NRAS mutation — biomarker · CancerIndex

Biomarker · Gene alteration

NRAS mutation

Activating NRAS mutations detected by sequencing or PCR; used as a predictive marker in colorectal cancer (anti-EGFR antibodies) and studied in melanoma.

CI-BIO-00000017NRAS graph →NCIt C41381 Tumor-agnostic · 4 approval rows

Also calledNRAS-mutant · NRAS-mutated

Tissue-agnostic indications

Approval rows flagged tumor-agnostic (4)

Dabrafenib US FDA · Mar 16, 2023 · drug in derived setRegulatory approved
Dabrafenib US FDA · May 29, 2013 · drug in derived setRegulatory approved
Trametinib US FDA · Mar 16, 2023 · drug in derived setRegulatory approved
Trametinib US FDA · May 29, 2013 · drug in derived setRegulatory approved

The flag is the source's (openFDA label text), never inferred; the full indication text of each row is in the Approvals section below.

Derived

Associated cancers (13)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Malignant Colorectal Neoplasm	17	16	1	—	1 / 6 / 8 / 2 / 0
Melanoma	15	12	2	1	0 / 6 / 6 / 3 / 0
Cutaneous Melanoma	9	9	—	—

Derived

Drugs with predictive evidence (20)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
CetuximabMonoclonal Antibody	14	—	14	A	0 / 13	Malignant Colorectal Neoplasm
BinimetinibSmall Molecule	8	8	—	B	7 / 0	Cutaneous Melanoma, Melanoma, Neuroblastoma, Solid Neoplasm
TrametinibSmall Molecule	6	6	—	B	5 / 0	Cutaneous Melanoma, Lung Non-Small Cell Carcinoma, Malignant Neoplasm, Malignant Ovarian Serous Tumor +1
SelumetinibSmall Molecule	6	6	—	B	4 / 0	Cutaneous Melanoma, Lung Non-Small Cell Carcinoma, Malignant Colorectal Neoplasm, Malignant Neoplasm
BelvarafenibSmall Molecule	5	5	—	C	5 / 0	Acral Lentiginous Melanoma, Melanoma, Mucosal Melanoma
Chemotherapy	4	—	4	B	0 / 4	Malignant Colorectal Neoplasm
IrinotecanSmall Molecule	4	—	4	C	0 / 4	Malignant Colorectal Neoplasm
VemurafenibSmall Molecule	3	—	3	B	0 / 3	Cutaneous Melanoma, Melanoma
PanitumumabMonoclonal Antibody	2	—	2	A	0 / 2	Malignant Colorectal Neoplasm
TemozolomideSmall Molecule	2	2	—	C	2 / 0	Melanoma
AmuvatinibSmall Molecule	1	1	—	D	1 / 0	Cutaneous Melanoma
DabrafenibSmall Molecule	1	—	1	B	0 / 1	Melanoma
DactolisibSmall Molecule	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
DocetaxelSmall Molecule	1	1	—	B	1 / 0	Cutaneous Melanoma
EverolimusSmall Molecule	1	1	—	D	1 / 0	Neuroblastoma
MetforminSmall Molecule	1	1	—	D	1 / 0	Malignant Neoplasm
OmipalisibSmall Molecule	1	1	—	D	1 / 0	Melanoma
RibociclibSmall Molecule	1	1	—	B	1 / 0	Cutaneous Melanoma
TanespimycinSmall Molecule	1	1	—	C	1 / 0	Melanoma
MEK Inhibitor RO4987655	1	—	1	C	—	Melanoma

Curatedcivic items and knowledge edges as curated at the source.

Curated evidence

Predictive evidence items (47)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 1–47 of 47 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
NRAS G13R3
Belvarafenib	Acral Lentiginous Melanoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID13214 A patient with acral melanoma harboring NRAS G13R received belvarafenib monotherapy after four prior lines of systemic therapy and achieved stable disease as the best RECIST response. The patient rece… (full text at CIViC) PMID 38470950 · Kim et al., 2024 · Open in CIViC	civic
Cetuximab + IrinotecanCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	1	accepted	EID2204 One patient participating in a large retrospective study of cetuximab in metastatic, treatment refractory colorectal cancer had a tumor which harbored NRAS G13R, was wildtype for KRAS, BRAF and PIK3CA… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
Panitumumab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	1	accepted	EID3842 One patient participating in a large retrospective study of cetuximab in metastatic, treatment refractory colorectal cancer had a tumor which harbored NRAS G13R, was wildtype for KRAS, BRAF and PIK3CA… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
NRAS Q61K8
Belvarafenib	Acral Lentiginous Melanoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID13218 A patient with acral melanoma harboring NRAS Q61K received belvarafenib as first-line therapy for metastatic disease after progression on adjuvant pembrolizumab and achieved stable disease as the best… (full text at CIViC) PMID 38470950 · Kim et al., 2024 · Open in CIViC	civic
Selumetinib	Cutaneous MelanomaALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID1475 Preclinical study in melanoma cell lines. NRAS Q61K, in addition to the BRAF V600E mutation was associated with resistance to vemurafenib but sensitivity to AZD6244 (selumetinib) in vitro in the acqui… (full text at CIViC) PMID 22194965 · Atefi et al., 2011 · Open in CIViC	civic
Vemurafenib	Cutaneous MelanomaALIAS	Predictive
NRAS Mutation14
Amuvatinib	Cutaneous MelanomaALIAS	Predictive	D	Supports Sensitivity Response	1	accepted	EID1476 Preclinical study in melanoma cell lines. Cell lines (2-5/assay) with NRAS mutation were more sensitive to Amuvatinib (inhibitor targets multiple tyrosine kinases) than BRAF mutant cell lines in growt… (full text at CIViC) PMID 24950457 · Fedorenko et al., 2014 · Open in CIViC	civic
Binimetinib	Cutaneous MelanomaALIAS	Predictive	B	Supports Sensitivity Response	2	accepted	EID1472 Phase II study in 71 patients with NRAS or BRAF V600 mutant melanoma treated with MEK162. Six (20%) of 30 patients with NRAS-mutated melanoma had a partial response (three confirmed). PMID 23414587 · Ascierto et al., 2013 · Open in CIViC	civic
〃	Cutaneous MelanomaALIAS
NRAS Q615
Binimetinib	Cutaneous MelanomaALIAS	Predictive	B	Supports Sensitivity Response	2	accepted	EID1226 Phase 2 study of MEK162 in patients with advanced melanoma and NRAS or BRAF mutation. 71 patients were enrolled, 6/30 patients with NRAS mutation had a partial response (Gln61Leu 1 Patient, Gln61Lys 9… (full text at CIViC) PMID 23414587 · Ascierto et al., 2013 · Open in CIViC	civic
Selumetinib	Cutaneous MelanomaALIAS	Predictive	C	Supports Sensitivity Response	2	accepted	EID1473 Phase 1 trial in 57 patients with advanced cancers treated with selumetinib. 4 melanoma patients had NRAS Q61 mutations. One patient with NRAS mutation had 70% tumor shrinkage after three cycles of se… (full text at CIViC) PMID 18390968 · Adjei et al., 2008 · Open in CIViC	civic
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER
NRAS G12D2
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	—	accepted	EID3693 In a retrospective study of 148 treatment naive metastatic colorectal cancer patients, patients with RAS mutations (n=10), including KRAS A146T, KRAS G13D, NRAS G12D and NRAS Q179*, treated with FOLFO… (full text at CIViC) PMID 25666295 · Kaczirek et al., 2015 · Open in CIViC	civic
Cetuximab + IrinotecanCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID2002 One patient participating in a large retrospective trial of cetuximab in metastatic, treatment refractory colorectal cancer had a tumor which harbored NRAS G12D and was wild type for KRAS, PIK3CA, and… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
NRAS Q179*1
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Resistance	—	accepted	EID4785 In a retrospective study of 148 treatment naive metastatic colorectal cancer patients, patients with RAS mutations (n=10), including KRAS A146T, KRAS G13D, NRAS G12D and NRAS Q179*, treated with FOLFO… (full text at CIViC) PMID 25666295 · Kaczirek et al., 2015 · Open in CIViC	civic
NRAS Q61R3
Cetuximab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID2184 Five patients participating in a large retrospective study of cetuximab in metastatic, treatment refractory colorectal cancer had tumors which harbored NRAS Q61R and were wildtype for KRAS, BRAF and P… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
Belvarafenib	Melanoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID13220 A patient with melanoma harboring NRAS Q61R received belvarafenib monotherapy after one prior line of systemic therapy and achieved stable disease as the best RECIST response. At the October 2023 data… (full text at CIViC) PMID 38470950 · Kim et al., 2024 · Open in CIViC	civic
Temozolomide	Melanoma	Predictive	C	Supports Sensitivity Response
NRAS G12C1
Cetuximab + ChemotherapyCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID3845 Two patients participating in a large retrospective trial of cetuximab in metastatic, treatment refractory colorectal cancer had tumors which harbored NRAS G12C and were wild type for KRAS, PIK3CA, an… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
NRAS Q61L3
Cetuximab + IrinotecanCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID2181 Two patients participating in a large retrospective study of cetuximab in metastatic, treatment refractory colorectal cancer had tumors which harbored NRAS Q61L and were wildtype for KRAS, BRAF and PI… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
Temozolomide	Melanoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID22 In a melanoma patient with NRAS Q61L mutation, treatment with temozolomide resulted in disease free survival of 14 months. PMID 21576590 · Soon et al., 2011 · Open in CIViC	civic
Belvarafenib	Mucosal Melanoma	Predictive	C	Supports Sensitivity Response
NRAS Q61H1
Cetuximab + IrinotecanCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID3690 One patient participating in a large retrospective study of cetuximab in metastatic, treatment refractory colorectal cancer had a tumor which harbored NRAS Q61H was wildtype for KRAS, BRAF and PIK3CA.… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
BRAF V600E + HRAS Mutation + KRAS Mutation + NF1 Mutation + NRAS MutationHRAS BRAF NF1 KRAS NRAS1
Selumetinib	Malignant NeoplasmALIAS	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID11681 In this phase II study of the arm E of the NCI-COG pediatric MATCH trial, 20 patients (median age: 14) were treated with Selumetinib. High-grade glioma (n=7) and rhabdomyosarcoma (n=7) were the most c… (full text at CIViC) PMID 35363510 · Eckstein et al., 2022 · Open in CIViC	civic
BRAF V600E + HRAS Mutation + KRAS Mutation + NF1 Inactivating Mutation + NRAS MutationHRAS NF1 BRAF KRAS NRAS1
Selumetinib	Malignant NeoplasmALIAS	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID11696 In this Phase II study, 20 patients harboring activating RAS gene mutations (KRAS = 8, NRAS = 3. HRAS = 1), BRAF V600E mutations, and NF1 inactivating mutations (n=7) were treated with Selumetinib. No… (full text at CIViC) PMID 35363510 · Eckstein et al., 2022 · Open in CIViC	civic
NRAS G12A1
Belvarafenib	Melanoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID13153 A patient with melanoma harboring NRAS G12A received belvarafenib monotherapy after two prior lines of systemic therapy and achieved a partial response as the best RECIST response. Belvarafenib treatm… (full text at CIViC) PMID 38470950 · Kim et al., 2024 · Open in CIViC	civic
NRAS Gain1
Binimetinib	Melanoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID6899 In melanoma preclinical models, increased NRAS expression enhanced sensitivity to binimetinib in NRAS-copy-normal A875 cells, whereas NRAS knockdown decreased binimetinib sensitivity in NRAS-gain WM26… (full text at CIViC) PMID 29245078 · Yan et al., 2018 · Open in CIViC	civic
NRAS G13D1
Tanespimycin	Melanoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID21 Likely due to increased reliance of mutant NRAS on HSP90 for stabilization, inhibition of HSP90 by 17-AAG was shown to be effective in a patient with metastatic malignant melanoma with an NRAS G13D mu… (full text at CIViC) PMID 18375819 · Banerji et al., 2008 · Open in CIViC	civic
BRAF V600E + NRAS MutationBRAF NRAS1
Dabrafenib + VemurafenibSubstitutes	Melanoma	Predictive	B	Supports Resistance	2	accepted	EID6263 In a retrospective study of 44 relapsed melanoma patients harboring BRAF V600E or V600K (known BRAF inhibitor sensitizing mutations), MAPK pathway reactivation mechanisms were implicated in acquired r… (full text at CIViC) PMID 24265155 · Shi et al., 2014 · Open in CIViC	civic

Regulatory

Approvals mentioning the linked drugs (333)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

openfdaRegulatory50 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Dabrafenib	US FDA	—	Efficacy supplement 2014-01-09 (see label)	approved	Jan 9, 2014	openfda
Dabrafenib	US FDA	Lung Non-Small Cell Carcinoma	the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.	approved	May 29, 2013	openfda
Dabrafenib	US FDA	Melanoma	the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.	approved	May 29, 2013	openfda
Dabrafenib	US FDA

Health Canada DIN rows carry no indication text and only match by drug.

Clinical trials

Active trials (349)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 188 recruiting · 62 active phase 3 · 1,723 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 349 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04793958	Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)	active not recruiting	Phase 3	461	Mirati Therapeutics Inc.INDUSTRY	32	Sep 28, 2026	clinicaltrials
NCT05867251	Study of AVZO-021 in Patients With Advanced Solid Tumors	recruiting	Phase 1 / Phase 2	430	Avenzo Therapeutics, Inc.INDUSTRY	2	Sep 28, 2026	clinicaltrials
NCT05981703	A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors	recruiting	Phase 1	337	BeOne MedicinesINDUSTRY	4	Sep 28, 2026	clinicaltrials
NCT06820463	A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer(AndroMETa-CRC)	recruiting	Phase 2	390	AbbVieINDUSTRY	15	Sep 28, 2026	clinicaltrials
NCT02595931	M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery	active not recruiting	Phase 1	66	National Cancer Institute (NCI)NIH	1	Sep 25, 2026	clinicaltrials
NCT05132075	Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer(KontRASt-02)	active not recruiting	Phase 3	95	Novartis PharmaceuticalsINDUSTRY	25	Sep 25, 2026	clinicaltrials
NCT06369259	Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer	recruiting	Phase 2	33	M.D. Anderson Cancer CenterOTHER	1	Sep 25, 2026	clinicaltrials
NCT07271355	Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial	recruiting	Phase 3	129	City of Hope Medical CenterOTHER	1	Sep 25, 2026	clinicaltrials
NCT07659795	A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer(TARGET-D 203)	recruiting	Phase 2	150	Verastem, Inc.INDUSTRY	2	Sep 25, 2026	clinicaltrials
NCT05863195	Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial	recruiting	Phase 3	408	ECOG-ACRIN Cancer Research GroupNETWORK	1	Sep 24, 2026	clinicaltrials
NCT06172296	Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma	recruiting	Phase 3	478	National Cancer Institute (NCI)NIH	5	Sep 24, 2026	clinicaltrials
NCT06995872	Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma	recruiting	Phase 1	40	National Cancer Institute (NCI)NIH	1	Sep 24, 2026	clinicaltrials
NCT07839819	Study of PM54 in Combination With Cytotoxic and Targeted Agents in Adult Participants With Advanced Malignancies	not yet recruiting	Phase 1 / Phase 2	231	PharmaMarINDUSTRY	4	Sep 24, 2026	clinicaltrials
NCT02392429	FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia	active not recruiting	Phase 2	87	National Cancer Institute (NCI)NIH	1	Sep 23, 2026	clinicaltrials
NCT03340506	Dabrafenib and/or Trametinib Rollover Study	recruiting	Phase 4	100	Novartis PharmaceuticalsINDUSTRY	14	Sep 23, 2026	clinicaltrials
NCT03899155	Pan Tumor Rollover Study	recruiting	Phase 2	1,500	Bristol-Myers SquibbINDUSTRY	38	Sep 23, 2026	clinicaltrials
NCT06102902	Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer	recruiting	Phase 1	30	National Cancer Institute (NCI)NIH	1	Sep 23, 2026	clinicaltrials
NCT04928846	A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)	recruiting	Phase 3	768	AbbVieINDUSTRY	32	Sep 22, 2026	clinicaltrials
NCT06445062	Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors	recruiting	Phase 1 / Phase 2	1,130	Revolution Medicines, Inc.INDUSTRY	1	Sep 22, 2026	clinicaltrials
NCT07415031	A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies	recruiting	Phase 2	170	Mirati Therapeutics Inc.INDUSTRY	20	Sep 22, 2026	clinicaltrials
NCT04544111	PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer	active not recruiting	Phase 2	19	Memorial Sloan Kettering Cancer CenterOTHER	1	Sep 17, 2026	clinicaltrials
NCT07349537	Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors	recruiting	Phase 1	574	Revolution Medicines, Inc.INDUSTRY	1	Sep 17, 2026	clinicaltrials
NCT07566052	A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation	recruiting	Phase 3	356	Astellas Pharma Global Development, Inc.INDUSTRY	3	Sep 17, 2026	clinicaltrials
NCT04211675	NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab(STING)	active not recruiting	Phase 1 / Phase 2	31	Nationwide Children's HospitalOTHER	1	Sep 16, 2026	clinicaltrials
NCT05786924	Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies	recruiting	Phase 1 / Phase 2	554	Institut de Recherches Internationales ServierOTHER	10	Sep 16, 2026	clinicaltrials
NCT07492680	A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)	recruiting	Phase 2	260	Bristol-Myers SquibbINDUSTRY	13	Sep 16, 2026	clinicaltrials
NCT02196181	Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread	active not recruiting	Phase 2	280	National Cancer Institute (NCI)NIH	1	Sep 15, 2026	clinicaltrials
NCT04511013	A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases	recruiting	Phase 2	112	SWOG Cancer Research NetworkNETWORK	1	Sep 15, 2026	clinicaltrials
NCT07044362	Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis	recruiting	N/A	100	Case Comprehensive Cancer CenterOTHER	1	Sep 15, 2026	clinicaltrials
NCT03149029	Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma	active not recruiting	Phase 2	16	Massachusetts General HospitalOTHER	1	Sep 14, 2026	clinicaltrials
NCT04140526	Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC(PRESERVE-001)	active not recruiting	Phase 1 / Phase 2	733	OncoC4, Inc.INDUSTRY	2	Sep 14, 2026	clinicaltrials
NCT05067283	A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)(KANDLELIT-001)	recruiting	Phase 1	830	Merck Sharp & Dohme LLCINDUSTRY	21	Sep 14, 2026	clinicaltrials
NCT06596473	A Study of BG-C477 in Participants With Advanced Solid Tumors	recruiting	Phase 1	310	BeOne MedicinesINDUSTRY	8	Sep 14, 2026	clinicaltrials
NCT04485013	TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers	active not recruiting	Phase 1	240	Tizona Therapeutics, IncINDUSTRY	1	Sep 11, 2026	clinicaltrials
NCT04929223	A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)	recruiting	Phase 1	542	Hoffmann-La RocheINDUSTRY	11	Sep 11, 2026	clinicaltrials
NCT05845450	Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)	recruiting	Phase 2	197	Gruppo Oncologico del Nord-OvestOTHER	1	Sep 11, 2026	clinicaltrials
NCT05985954	Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy	recruiting	Phase 1	27	M.D. Anderson Cancer CenterOTHER	1	Sep 11, 2026	clinicaltrials
NCT07247110	A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)	recruiting	Phase 1	250	Merck Sharp & Dohme LLCINDUSTRY	7	Sep 11, 2026	clinicaltrials
NCT07381764	ROMANCE: "Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer"(ROMANCE - GOIM)	recruiting	Phase 2	150	Gruppo Oncologico Italia MeridionaleOTHER	1	Sep 11, 2026	clinicaltrials
NCT07746141	A First-in-Human Study Investigating BG-85738 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors With Rat Sarcoma Virus (RAS) Mutations	recruiting	Phase 1	100	BeOne MedicinesINDUSTRY	1	Sep 11, 2026	clinicaltrials
NCT01364051	Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies	active not recruiting	Phase 1	19	National Cancer Institute (NCI)NIH	1	Sep 10, 2026	clinicaltrials
NCT04302025	A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)(NAUTIKA1)	recruiting	Phase 2	99	Genentech, Inc.INDUSTRY	1	Sep 10, 2026	clinicaltrials
NCT06266299	A Study of KK2269 in Adult Participants With Solid Tumors	recruiting	Phase 1	101	Kyowa Kirin Co., Ltd.INDUSTRY	2	Sep 10, 2026	clinicaltrials
NCT07775287	Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2)	recruiting	Phase 3	600	GenmabINDUSTRY	1	Sep 10, 2026	clinicaltrials
NCT06578559	Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC(BRICKET)	active not recruiting	Phase 2	16	Gruppo Oncologico del Nord-OvestOTHER	1	Sep 9, 2026	clinicaltrials
NCT06625775	Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors	recruiting	Phase 1	392	TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)INDUSTRY	6	Sep 9, 2026	clinicaltrials
NCT03006172	To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer	active not recruiting	Phase 1	200	Genentech, Inc.INDUSTRY	5	Sep 8, 2026	clinicaltrials
NCT07807878	Trial of Temozolomide in BAP1 Mutated Patients With Advanced or Metastatic Cutaneous Melanoma(BAP1treat)	not yet recruiting	Phase 2	28	Assistance Publique Hopitaux De MarseilleOTHER	0	Sep 8, 2026	clinicaltrials
NCT02642042	Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer	active not recruiting	Phase 2	60	National Cancer Institute (NCI)NIH	1	Sep 4, 2026	clinicaltrials
NCT04589845	Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study	active not recruiting	Phase 2	920	Hoffmann-La RocheINDUSTRY	23	Sep 4, 2026	clinicaltrials

A study listed here tests a linked drug in a linked cancer; it does not necessarily select participants on this biomarker.

Docetaxel

EU EMA

—

Breast cancer Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxespira in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. Taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small cell lung cancer Taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Taxespira in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

withdrawnsince Oct 30, 2018

Aug 28, 2015

ema

Docetaxel

EU EMA

—

Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Kabi monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer. Docetaxel Kabi in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer. Gastric adenocarcinoma Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

approved

May 22, 2012

ema

Docetaxel

EU EMA

—

Breast cancer Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Accord in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

approved

May 22, 2012

ema

Docetaxel

EU EMA

—

Breast cancer Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small cell lung cancer Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Docetaxel in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

withdrawnsince May 25, 2012

May 10, 2010

ema

Docetaxel

EU EMA

—

Breast cancer Docetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Teva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Teva in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Teva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Teva in combination with cisplatin and 5 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

withdrawn

Jan 26, 2010

ema

Docetaxel

EU EMA

—

Breast cancer Docetaxel Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Winthrop in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Winthrop monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Winthrop in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Winthrop in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

withdrawn

Apr 20, 2007

ema

Docetaxel

EU EMA

—

Breast cancer Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

approved

Nov 27, 1995

ema

Approval rows flagged tumor-agnostic (4)

Associated cancers (13)

Drugs with predictive evidence (20)

Predictive evidence items (47)

Approvals mentioning the linked drugs (333)

Active trials (349)

Linked publications (37)