ALK rearrangement / fusion — biomarker · CancerIndex

Biomarker · Gene alteration

ALK rearrangement / fusion

ALK gene rearrangements (most often EML4-ALK) detected by FISH, immunohistochemistry or sequencing; used as a predictive marker for ALK inhibitors in non-small cell lung cancer and some lymphomas.

CI-BIO-00000013ALK graph →NCIt C142135 Tumor-agnostic · 3 approval rows

Also calledALK-positive · ALK rearrangement · EML4-ALK · ALK fusion

Tissue-agnostic indications

Approval rows flagged tumor-agnostic (3)

Entrectinib EU EMA · Jul 31, 2020 · drug in derived setRegulatory approved
Entrectinib US FDA · Oct 20, 2023 · drug in derived setRegulatory approved
Entrectinib US FDA · Aug 15, 2019 · 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 (20)

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
Lung Non-Small Cell Carcinoma	80	80	—	—	9 / 12 / 23 / 35 / 1
Neuroblastoma	18	18	—	—	0 / 0 / 6 / 12 / 0
Malignant Neoplasm	10	10	—

Derived

Drugs with predictive evidence (16)

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
CrizotinibSmall Molecule	73	45	28	A	45 / 52	Anaplastic Large Cell Lymphoma, Colorectal Adenocarcinoma, Cutaneous Melanoma, Diffuse Large B-Cell Lymphoma +8
AlectinibSmall Molecule	23	13	10	A	14 / 17	Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma, Malignant Neoplasm, Neuroblastoma +3
CeritinibSmall Molecule	18	15	3	A	21 / 5	Colon Adenocarcinoma, Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma, Malignant Neoplasm +1
LorlatinibSmall Molecule	10	7	3	B	10 / 7	Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma, Neuroblastoma, Pleural Malignant Mesothelioma
ALK Inhibitor TAE684	9	7	2	D	7 / 3	Diffuse Large B-Cell Lymphoma, Lung Non-Small Cell Carcinoma, Neuroblastoma
BrigatinibSmall Molecule	6	5	1	A	7 / 2	Lung Non-Small Cell Carcinoma, Malignant Neoplasm, Neuroblastoma
EntrectinibSmall Molecule	5	5	—	B	4 / 0	Inflammatory Myofibroblastic Tumor, Malignant Colorectal Neoplasm, Malignant Neoplasm, Mucosal Melanoma +1
AlvespimycinSmall Molecule	3	3	—	D	2 / 0	Lung Non-Small Cell Carcinoma
TanespimycinSmall Molecule	2	2	—	D	4 / 0	Lung Non-Small Cell Carcinoma
Retaspimycin HydrochlorideSmall Molecule	2	2	—	C	2 / 0	Lung Non-Small Cell Carcinoma
LuminespibSmall Molecule	1	—	1	C	0 / 2	Lung Non-Small Cell Carcinoma
2,4-pyrimidinediamine	1	1	—	D	1 / 0	Lung Non-Small Cell Carcinoma
AZD3463	1	1	—	D	1 / 0	Neuroblastoma
ErlotinibSmall Molecule	1	—	1	C	0 / 1	Lung Acinar Adenocarcinoma
PemetrexedSmall Molecule	1	1	—	B	1 / 0	Lung Non-Small Cell Carcinoma
WHI-P154	1	1	—	D	1 / 0	Lung Non-Small Cell Carcinoma

Curatedcivic items and knowledge edges as curated at the source.

Curated evidence

Predictive evidence items (148)

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

civicCuratedShowing 101–148 of 148 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
ALK C1156Y + ALK L1198F + ALK Fusion1
Lorlatinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	4	accepted	EID843 Case report of a patient with metastatic ALK-rearranged NSCLC. After developing resistance to first and second line ALK inhibitors mediated by a C1156Y mutation, the patient had a partial response wit… (full text at CIViC) PMID 26698910 · Shaw et al., 2016 · Open in CIViC	civic
ALK Fusion3
Lorlatinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID1332 EML4-ALK variant 1 containing H-3122 NSCLC cells were treated with second generation ALK inhibitor PF-06463922. PF-06463922 was 125x more potent at reducing cell viability than crizotinib. Control neu… (full text at CIViC) PMID 26554404 · Infarinato et al., 2016 · Open in CIViC	civic
WHI-P154	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	5	accepted	EID1188 A retroviral cDNA expression library was constructed using a lung adenocarcinoma specimen from a 67 year old NSCLC patient, and transfected into mouse 3T3 fibroblasts which were assessed for transform… (full text at CIViC) PMID 17625570 · Soda et al., 2007 · Open in CIViC	civic
Alectinib	Pleural Malignant Mesothelioma
ALK Fusion7
Pemetrexed	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID945 Among 95 patients with NSCLC in this study, 15 had an ALK translocation. ORR of these patients compared to EGFR mutated or wild-type tumors was superior (46.7 versus 4.7 versus 16.2%, p = 0.001). TYMS… (full text at CIViC) PMID 21642865 · Lee et al., 2011 · Open in CIViC	civic
Retaspimycin Hydrochloride	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	2	accepted	EID1202 In this study, heavily pretreated advanced NSCLC patients with various molecular tumor makeup were treated with Hsp90 inhibitor IPI-504 to assess overall response rate. The study did not reach the tar… (full text at CIViC) PMID 20940188 · Sequist et al., 2010 · Open in CIViC	civic
Crizotinib	Malignant Breast Neoplasm
ALK T1151dup + ALK Fusion1
Tanespimycin	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID1349 Ba/F3 cells transduced with EML4-ALK 1151 insT were treated with 17-AAG producing an IC50 value of 44.5 nM, which was 0.4 times that reported for EML4-ALK wildtype in Ba/F3, indicating possible increa… (full text at CIViC) PMID 22277784 · Katayama et al., 2012 · Open in CIViC	civic
ALK G1202R + ALK Fusion3
Tanespimycin	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID1352 The G1202R ALK mutation was found in a crizotinib-resistant ALK-rearranged NSCLC, and the mutant ALK fusion was further characterized in Ba/F3 cells. EML4-ALK variant 1 with G1202R mutation was expres… (full text at CIViC) PMID 22277784 · Katayama et al., 2012 · Open in CIViC	civic
Alectinib	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	3	accepted	EID1350 Ba/F3 cell line expressing EML4-ALK variant 3 with G1202R ALK mutation was assessed for alectinib sensitivity and IC50 for survival of 868 nM was reported, which was 64.4x higher than the IC50 reporte… (full text at CIViC) PMID 25727400 · Fontana et al., 2015 · Open in CIViC	civic
Brigatinib	Malignant NeoplasmALIAS
ALK Fusion1
Entrectinib	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID7481 A patient with colorectal cancer harboring a CAD-ALK fusion gene was treated with the ALK inhibitor entrectinib, resulting in durable objective tumor response. A CT scan four weeks after treatment ini… (full text at CIViC) PMID 26633560 · Amatu et al., 2015 · Open in CIViC	civic
ALK G1269A + ALK Fusion3
Alectinib	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	3	accepted	EID1354 EML4-ALK with ALK G1269A mutation was tested for sensitivity to alectinib using Ba/F3 cells. In Ba/F3 cells with ectopic EML4-ALK variant 1 G1269A, IC50 of 84 nM was reported with alectinib, which was… (full text at CIViC) PMID 25727400 · Fontana et al., 2015 · Open in CIViC	civic
Brigatinib	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID1353 EML4-ALK with ALK G1269A has been seen in crizotinib resistant NSCLC, and this mutation was tested for Brigatinib sensitivity via ectopic expression in Ba/F3 cells, where half maximal inhibitory conce… (full text at CIViC) PMID 25727400 · Fontana et al., 2015 · Open in CIViC	civic
Ceritinib	Malignant NeoplasmALIAS
ALK Fusion + ROS1 FusionALK ROS11
Crizotinib	Malignant NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	2	accepted	EID11671 This clinical study was conducted on patients harboring either ROS1 or ALK rearrangements, and were treated with Crizotinib. The two sub-protocols F(ALK rearrangements) and G(ROS1 rearrangements) had … (full text at CIViC) PMID 35233056 · Mansfield et al., 2022 · Open in CIViC	civic
ALK e6::e201
Crizotinib	Malignant NeoplasmALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID1245 This case study presented a 53-year-old never-smoker with a poorly differentiated malignant neoplasm. Morphology and immunohistochemistry were unable to establish the primary tumor site. Right upper e… (full text at CIViC) PMID 25408655 · Chung et al., 2014 · Open in CIViC	civic
ALK F1245C + ALK Fusion1
Crizotinib	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	2	accepted	EID1337 A Ba/F3 cell line expressing EML4-ALK variant 1 was created, and then exposed to the DNA modifying agent ENU. Cells were subsequently cultured in 96 well plates at increasing concentrations of crizoti… (full text at CIViC) PMID 22034911 · Zhang et al., 2011 · Open in CIViC	civic
ALK Fusion1
Crizotinib	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID1356 In Ba/F3 cells, crizotinib sensitivty of the NPM-ALK variant was compared to crizotinib sensitivity of EML4-ALK variant 3. 50% of maximal inhibitory concentration for NPM-ALK was 42 nM, which was appr… (full text at CIViC) PMID 25727400 · Fontana et al., 2015 · Open in CIViC	civic
ALK Alternative Transcript (ATI)1
Entrectinib	Mucosal Melanoma	Predictive	C	Does Not Support Sensitivity Response	4	accepted	EID7421 ALK expression was analyzed in 45 melanoma patient-derived xenografts (PDXs), with 11/45 showing ALK expression. Four PDX tumours had only wild-type ALK expression, four had only ALK alternative trans… (full text at CIViC) PMID 29054983 · Couts et al., 2018 · Open in CIViC	civic
ALK F1174L7
Alectinib	Neuroblastoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID37 CH5424802 (Alectinib) is effective in inhibiting the activity of the F1174L ALK mutant in a kinase activity assay and proliferation assay using neuroblastoma KELLY cells. PMID 21575866 · Sakamoto et al., 2011 · Open in CIViC	civic
ALK Inhibitor TAE684	Neuroblastoma	Predictive	D	Supports Sensitivity Response	4	accepted	EID142 SH-SY5Y and Kelly cells with mutant ALK (F1174L) and Ba/F3 cells overexpressing ALK harboring the F1174L mutation are sensitive to TAE684-mediated growth inhibition. PMID 18923525 · George et al., 2008 · Open in CIViC	civic
AZD3463	Neuroblastoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID1327 The SH-SY5Y neuroblastoma cell line containing the F1174L ALK mutation was found to undergo cell death when treated with the ALK/IGF1R inhibitor AZD3463. These cells were more sensitive than other neu…
ALK R1275Q6
ALK Inhibitor TAE684	Neuroblastoma	Predictive	D	Supports Sensitivity Response	2	accepted	EID39 This study identified previously unknown mutations in the ALK gene in 8% (7/93) of primary neuroblastomas and neuroblastoma cell lines (6/30). R1275Q was found in the germline of one patient sample an… (full text at CIViC) PMID 18923525 · George et al., 2008 · Open in CIViC	civic
〃	Neuroblastoma	Predictive	D	Supports Resistance	3	accepted	EID48 The SMS-KCNR cell line harboring the R1275Q mutation was resistant to TAE684. PMID 18923525 · George et al., 2008 · Open in CIViC	civic
Crizotinib	Neuroblastoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID1269 This Phase I study of crizotinib involved a cohort of pediatric neuroblastoma patients between ages 12 months and 22 years. In 11 patients with characterized ALK mutations, 4 had R1275Q mutations, and…
ALK Exon 4-11 Deletion1
Brigatinib	Neuroblastoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID1336 The MYCN amplification positive relapsed neuroblastoma-derived cell line CLB-BAR contains the driver ALK DEL 11-14 mutation, which removes extracellular domain exons 4 through 11. Brigatinib treatment… (full text at CIViC) PMID 27049722 · Siaw et al., 2016 · Open in CIViC	civic
ALK I1171T1
Ceritinib	Neuroblastoma	Predictive	C	Supports Sensitivity Response	4	accepted	EID9404 This case reports a 16-mo-old boy with metastatic neuroblastoma (stage M). Genomic analysis of a diagnostic biopsy of the tumor and matched normal identified two germline mutations in FANCA and somati… (full text at CIViC) PMID 29907598 · Guan et al., 2018 · Open in CIViC	civic
ALK F1245C2
Crizotinib	Neuroblastoma	Predictive	C	Supports Resistance	3	accepted	EID1333 A participant in Children's Oncology Group (COG) study AVDL0912 with measurable neuroblastoma mutated at ALK F1245C was administered crizotinib at 100mg twice daily. The patient showed progressive di… (full text at CIViC) PMID 23598171 · Mossé et al., 2013 · Open in CIViC	civic
Lorlatinib	Neuroblastoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID1330 Patient derived xenografts of neuroblastoma Felix cells with F1245C ALK mutation in CB17 SCID mice showed growth inhibition with crizotinib treatment over control, and mice had improved duration of ev… (full text at CIViC) PMID 26554404 · Infarinato et al., 2016 · Open in CIViC	civic
ALK F1245V1
Entrectinib	Neuroblastoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID2987 Clinical trial of entrectinib in patients with ALK/ROS/TRK altered tumors. One patient with an ALK F1245V-mutant neuroblastoma achieved a durable, confirmed partial response (PR) lasting 8.3 months. T… (full text at CIViC) PMID 28183697 · Drilon et al., 2017 · Open in CIViC	civic
ALK Fusion1
Alectinib	Pancreatic Acinar Cell CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID10327 Case report of a 62-year old male patient diagnosed with pancreatic acinar cell carcinoma. Liver metastases were diagnosed and treatment was started with gemcitabine plus nab-paclitaxel regimen. After… (full text at CIViC) PMID 35005993 · Gaule et al., 2022 · Open in CIViC	civic
ALK I1171N + ALK L1196M + ALK Fusion2
Alectinib	Pleural Malignant MesotheliomaALIAS	Predictive	C	Supports Resistance	4	accepted	EID11115 A 33 year old male with no smoking history or known exposure to asbestos was diagnosed with malignant pleural mesothelioma (MPM). EML4::ALK was found using a panel of 520 genes in NGS, and the patient… (full text at CIViC) PMID 32600123 · Hu et al., 2020 · Open in CIViC	civic
Lorlatinib	Pleural Malignant MesotheliomaALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID11113 This case report describes a 33 year-old non-smoker with no known exposure to asbestos who was diagnosed with stage IIIB malignant pleural mesothelioma. Panel next generation sequencing (NGS) of 520 g… (full text at CIViC) PMID 32600123 · Hu et al., 2020 · Open in CIViC	civic
ALK G1202R + ALK I1171N + ALK L1196M + ALK Fusion1
Lorlatinib	Pleural Malignant MesotheliomaALIAS	Predictive	C	Supports Resistance	3	accepted	EID11114 This case report describes a 33 year-old non-smoker with no known exposure to asbestos who was diagnosed with stage IIIB malignant pleural mesothelioma. Panel next generation sequencing (NGS) of 520 g… (full text at CIViC) PMID 32600123 · Hu et al., 2020 · Open in CIViC	civic
ALK e2::e201
Unspecified therapy	Renal Cell CarcinomaCURATED_BROADER	Predictive	E	Supports Sensitivity Response	3	accepted	EID1266 Adenocarcinoma cells were detected via urinary cytology in a 53 year old woman. Cancer morphology suggested papillary renal cell carcinoma (RCC), type 2A. EML4-ALK variant 5 was discovered in tumor t… (full text at CIViC) PMID 22252991 · Sugawara et al., 2012 · Open in CIViC	civic
ALK Exon 2-18 Deletion + TFCP2 FusionTFCP2 ALK1
Alectinib	Spindle Cell Rhabdomyosarcoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID12406 A 31 year old male initially thought to have a mandibular osteosarcoma that was resected and treated with adjuvant radiation and cisplatin-doxorubicin. He had a mandibular recurrence with multiple pul… (full text at CIViC) PMID 39302072 · Csizmok et al., 2024 · Open in CIViC	civic

Regulatory

Approvals mentioning the linked drugs (178)

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

emaRegulatory50 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
Entrectinib	EU EMA	Tumor-agnosticLung Non-Small Cell Carcinoma	Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor who have no satisfactory treatment options. Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.conditional	approved	Jul 31, 2020	ema
Entrectinib	US FDA	Tumor-agnostic	Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.accelerated	approved	Oct 20, 2023	openfda

4 records matched on indication text only (drug not in the derived set). Health Canada DIN rows carry no indication text and only match by drug.

Clinical trials

Active trials (227)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 105 recruiting · 85 active phase 3 · 868 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 51–100 of 227 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
NCT04736173	Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer(ARC-10)	active not recruiting	Phase 2	169	Arcus Biosciences, Inc.INDUSTRY	10	Aug 31, 2026	clinicaltrials
NCT07070440	DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)	recruiting	Phase 1 / Phase 2	180	Dizal PharmaceuticalsINDUSTRY	1	Aug 31, 2026	clinicaltrials
NCT04449874	A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation	active not recruiting	Phase 1	498	Genentech, Inc.INDUSTRY	17	Aug 28, 2026	clinicaltrials
NCT04025879	A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer	active not recruiting	Phase 3	461	Bristol-Myers SquibbINDUSTRY	22	Aug 26, 2026	clinicaltrials
NCT05722015	A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)	active not recruiting	Phase 3	377	Merck Sharp & Dohme LLCINDUSTRY	16	Aug 26, 2026	clinicaltrials
NCT06212752	A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension	active not recruiting	Phase 3	39	Merck Sharp & Dohme LLCINDUSTRY	1	Aug 26, 2026	clinicaltrials
NCT02568267	Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)(STARTRK-2)	active not recruiting	Phase 2	534	Hoffmann-La RocheINDUSTRY	16	Aug 25, 2026	clinicaltrials
NCT03126916	Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)	recruiting	Phase 3	750	Children's Oncology GroupNETWORK	3	Aug 25, 2026	clinicaltrials
NCT04165070	KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)	recruiting	Phase 1 / Phase 2	450	Merck Sharp & Dohme LLCINDUSTRY	9	Aug 25, 2026	clinicaltrials
NCT06765109	Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC(ALKAZAR)	recruiting	Phase 3	450	Nuvalent Inc.INDUSTRY	29	Aug 25, 2026	clinicaltrials
NCT07784959	Study of NXP900 With Lorlatinib in ALK+ Lung Cancer	recruiting	Phase 1	54	Nuvectis Pharma, Inc.INDUSTRY	1	Aug 25, 2026	clinicaltrials
NCT07680790	Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)	not yet recruiting	Phase 3	850	Bristol-Myers SquibbINDUSTRY	16	Aug 24, 2026	clinicaltrials
NCT07775040	Spatially Fractionated Radiotherapy With Tislelizumab and Chemotherapy for Bulky Stage III NSCLC: A Phase II Trial	not yet recruiting	Phase 2	43	Sichuan Cancer Hospital and Research InstituteOTHER	1	Aug 20, 2026	clinicaltrials
NCT06514027	Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations	recruiting	Phase 2	30	BeBetter Med IncINDUSTRY	1	Aug 18, 2026	clinicaltrials
NCT06731907	A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/KEYMAKER U01)	recruiting	Phase 2	90	Merck Sharp & Dohme LLCINDUSTRY	11	Aug 18, 2026	clinicaltrials
NCT05624996	Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer	recruiting	Phase 3	474	NRG OncologyOTHER	2	Aug 17, 2026	clinicaltrials
NCT05335941	A Phase 2 Study to Evaluate the Triplet Combination of Pemetrexed Plus AB928 (Etrumadenant) + AB122 (Zimberelimab) in Patients With Previously Treated Advanced or Metastatic MTAP Deficient Urothelial Carcinoma	active not recruiting	Phase 2	10	M.D. Anderson Cancer CenterOTHER	1	Aug 14, 2026	clinicaltrials
NCT06074588	Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)	active not recruiting	Phase 3	556	Merck Sharp & Dohme LLCINDUSTRY	25	Aug 14, 2026	clinicaltrials
NCT04603807	A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases	active not recruiting	Phase 3	217	Hoffmann-La RocheINDUSTRY	18	Aug 13, 2026	clinicaltrials
NCT06007937	A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer	active not recruiting	Phase 1 / Phase 2	9	Memorial Sloan Kettering Cancer CenterOTHER	1	Aug 13, 2026	clinicaltrials
NCT06956001	Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation	recruiting	Phase 3	300	Allist Pharmaceuticals, Inc.INDUSTRY	1	Aug 13, 2026	clinicaltrials
NCT04837716	Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer	active not recruiting	Phase 1	12	M.D. Anderson Cancer CenterOTHER	1	Aug 11, 2026	clinicaltrials
NCT06161441	A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery	active not recruiting	Phase 2	195	Regeneron PharmaceuticalsINDUSTRY	12	Aug 10, 2026	clinicaltrials
NCT05170204	A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)(HORIZON 1)	active not recruiting	Phase 3	68	Hoffmann-La RocheINDUSTRY	19	Aug 5, 2026	clinicaltrials
NCT04083599	GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors	active not recruiting	Phase 1 / Phase 2	350	GenmabINDUSTRY	12	Aug 4, 2026	clinicaltrials
NCT06969027	JS207Combined With Chemotherapy in First-line Treatment of Advanced NSCLC	active not recruiting	Phase 2	69	Shanghai Junshi Bioscience Co., Ltd.OTHER	1	Aug 4, 2026	clinicaltrials
NCT07642024	A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)	recruiting	Phase 2 / Phase 3	90	Sichuan Baili Pharmaceutical Co., Ltd.INDUSTRY	1	Aug 3, 2026	clinicaltrials
NCT02535312	Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Pemetrexed Disodium and Cisplatin or Carboplatin	active not recruiting	Phase 1 / Phase 2	30	National Cancer Institute (NCI)NIH	1	Jul 31, 2026	clinicaltrials
NCT07739966	A Study of DS-3939a in Participants With Solid Tumors	not yet recruiting	Phase 1 / Phase 2	400	Daiichi SankyoINDUSTRY	0	Jul 31, 2026	clinicaltrials
NCT02486718	Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]	active not recruiting	Phase 3	1,280	Hoffmann-La RocheINDUSTRY	21	Jul 29, 2026	clinicaltrials
NCT03425643	Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)	active not recruiting	Phase 3	797	Merck Sharp & Dohme LLCINDUSTRY	25	Jul 29, 2026	clinicaltrials
NCT04198766	Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)	recruiting	Phase 1 / Phase 2	340	Inhibrx Biosciences, IncINDUSTRY	4	Jul 29, 2026	clinicaltrials
NCT05984277	A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.(eVOLVE-Lung02)	active not recruiting	Phase 3	895	AstraZenecaINDUSTRY	25	Jul 28, 2026	clinicaltrials
NCT03768063	A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study(IMbrella B)	active not recruiting	Phase 3	1,000	Hoffmann-La RocheINDUSTRY	24	Jul 24, 2026	clinicaltrials
NCT06475300	A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors	recruiting	Phase 2	570	Sichuan Baili Pharmaceutical Co., Ltd.INDUSTRY	1	Jul 23, 2026	clinicaltrials
NCT04166487	Plasma-Adapted First-Line Pembro In NSCLC	active not recruiting	Phase 2	40	Julia K. Rotow, MDOTHER	1	Jul 22, 2026	clinicaltrials
NCT05098132	Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers(SYNERGY-101)	recruiting	Phase 1 / Phase 2	364	SynthekineINDUSTRY	4	Jul 21, 2026	clinicaltrials
NCT06996782	A Platform Study in Non-Small Cell Lung Cancer (NSCLC)(ALTAIR)	recruiting	Phase 1 / Phase 2	152	AstraZenecaINDUSTRY	20	Jul 21, 2026	clinicaltrials
NCT06607185	A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors	active not recruiting	Phase 1	750	Eli Lilly and CompanyINDUSTRY	8	Jul 20, 2026	clinicaltrials
NCT03456076	A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer	active not recruiting	Phase 3	257	Hoffmann-La RocheINDUSTRY	27	Jul 15, 2026	clinicaltrials
NCT05800015	A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer	active not recruiting	Phase 2 / Phase 3	160	Regeneron PharmaceuticalsINDUSTRY	10	Jul 15, 2026	clinicaltrials
NCT07405190	Ivonescimab Alone And With Carboplatin/Pemetrexed For NSCLC	recruiting	Phase 2	46	Massachusetts General HospitalOTHER	1	Jul 15, 2026	clinicaltrials
NCT05048797	A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations	active not recruiting	Phase 3	454	AstraZenecaINDUSTRY	20	Jul 10, 2026	clinicaltrials
NCT04328844	A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers	active not recruiting	Phase 1	210	iOncturaINDUSTRY	2	Jul 8, 2026	clinicaltrials
NCT06711900	A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer	active not recruiting	Phase 3	432	Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.INDUSTRY	1	Jul 8, 2026	clinicaltrials
NCT04077463	A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer(Chrysalis-2)	active not recruiting	Phase 1	701	Janssen Research & Development, LLCINDUSTRY	10	Jul 6, 2026	clinicaltrials
NCT06008093	A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS(TRITON)	active not recruiting	Phase 2	103	AstraZenecaINDUSTRY	1	Jul 2, 2026	clinicaltrials
NCT06839105	A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies	recruiting	Phase 1	214	Shanghai Junshi Bioscience Co., Ltd.OTHER	1	Jul 2, 2026	clinicaltrials
NCT04227028	Brigatinib and Bevacizumab for the Treatment of ALK-Rearranged Locally Advanced, Metastatic, or Recurrent NSCLC	active not recruiting	Phase 1	5	City of Hope Medical CenterOTHER	1	Jul 1, 2026	clinicaltrials
NCT05443126	A Study of EP0031 (Lunbotinib) in Patients With Advanced RET-altered Malignancies	recruiting	Phase 1 / Phase 2	265	Ellipses PharmaINDUSTRY	8	Jul 1, 2026	clinicaltrials

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

Atezolizumab

EU EMA

—

Urothelial carcinoma Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC): after prior platinum containing chemotherapy, or who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1). Early-stage non-small cell lung cancer (NSCLC) Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who do not have EGFR mutant or ALK positive NSCLC (see section 5.1 for selection criteria). Advanced NSCLC  Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5.1).Tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK positive NSCLC (see section 5.1).Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC (see section 5.1).Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy (see section 5.1 for selection criteria).Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving Tecentriq (see section 5.1).Small cell lung cancer (SCLC)Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1). Triple-negative breast cancer (TNBC)Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.Hepatocellular carcinomaTecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy (see section 5.1). Urothelial carcinoma (UC) Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC: after prior platinum containing chemotherapy, or who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1). Early-stage non-small cell lung cancer (NSCLC) Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who do not have EGFR mutant or ALK positive NSCLC (see section 5.1 for selection criteria). Advanced NSCLC  Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC. In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate target…

approved

Sep 20, 2017

ema

Durvalumab

EU EMA

—

Non-Small Cell Lung Cancer (NSCLC)Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Imfinzi as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1). Imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5.1).Imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations. Small Cell Lung Cancer (SCLC)Imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). Biliary Tract Cancer (BTC)Imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (BTC). Hepatocellular Carcinoma (HCC)Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).  Imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Endometrial Cancer Imfinzi in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with: - Imfinzi as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR) - Imfinzi in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). Muscle Invasive Bladder Cancer (MIBC) Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC). Gastric or Gastro-oesophageal Junction Adenocarcinoma (GC/GEJC) Imfinzi in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, is indicated for the treatment of adults with resectable gastric or gastro‑oesophageal junction adenocarcinoma.

approved

Sep 21, 2018

ema

Approval rows flagged tumor-agnostic (3)

Associated cancers (20)

Drugs with predictive evidence (16)

Predictive evidence items (148)

Approvals mentioning the linked drugs (178)

Active trials (227)

Linked publications (82)