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 (226)

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 · 867 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 226 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
NCT04988295	A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure(MARIPOSA-2)	active not recruiting	Phase 3	776	Janssen Research & Development, LLCINDUSTRY	29	Sep 28, 2026	clinicaltrials
NCT05498428	A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer(PALOMA-2)	recruiting	Phase 2	520	Janssen Research & Development, LLCINDUSTRY	12	Sep 28, 2026	clinicaltrials
NCT06623422	A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)	recruiting	Phase 3	680	Merck Sharp & Dohme LLCINDUSTRY	31	Sep 28, 2026	clinicaltrials
NCT07190248	A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)	recruiting	Phase 3	675	Merck Sharp & Dohme LLCINDUSTRY	30	Sep 28, 2026	clinicaltrials
NCT02609776	Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer(CHRYSALIS)	active not recruiting	Phase 1	751	Janssen Research & Development, LLCINDUSTRY	10	Sep 25, 2026	clinicaltrials
NCT04253964	Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy	recruiting	Phase 2	105	Wake Forest University Health SciencesOTHER	1	Sep 25, 2026	clinicaltrials
NCT04267848	Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])	recruiting	Phase 3	1,210	National Cancer Institute (NCI)NIH	2	Sep 25, 2026	clinicaltrials
NCT06312137	A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)(TroFuse-019)	recruiting	Phase 3	780	Merck Sharp & Dohme LLCINDUSTRY	31	Sep 25, 2026	clinicaltrials
NCT07586202	A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC(AmiNA)	recruiting	Phase 2	68	Janssen Research & Development, LLCINDUSTRY	6	Sep 25, 2026	clinicaltrials
NCT06096844	Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial	recruiting	Phase 3	304	National Cancer Institute (NCI)NIH	1	Sep 24, 2026	clinicaltrials
NCT02194738	Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)	active not recruiting	N/A	7,458	National Cancer Institute (NCI)NIH	3	Sep 23, 2026	clinicaltrials
NCT03899155	Pan Tumor Rollover Study	recruiting	Phase 2	1,500	Bristol-Myers SquibbINDUSTRY	38	Sep 23, 2026	clinicaltrials
NCT05144997	Lorlatinib Continuation Study	active not recruiting	Phase 4	76	PfizerINDUSTRY	8	Sep 23, 2026	clinicaltrials
NCT06452277	A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)(SOHO-02)	recruiting	Phase 3	555	BayerINDUSTRY	36	Sep 23, 2026	clinicaltrials
NCT06561386	A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%(RELATIVITY1093)	recruiting	Phase 3	1,000	Bristol-Myers SquibbINDUSTRY	31	Sep 23, 2026	clinicaltrials
NCT06564844	A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features(TROPION-Lung12)	active not recruiting	Phase 3	25	AstraZenecaINDUSTRY	10	Sep 23, 2026	clinicaltrials
NCT06140836	A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)	active not recruiting	Phase 3	190	Bristol-Myers SquibbINDUSTRY	21	Sep 22, 2026	clinicaltrials
NCT06712316	Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer	recruiting	Phase 2 / Phase 3	1,580	BioNTech SEINDUSTRY	22	Sep 22, 2026	clinicaltrials
NCT06772623	Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations	recruiting	Phase 1 / Phase 2	252	AbbVieINDUSTRY	15	Sep 22, 2026	clinicaltrials
NCT06875310	A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)	recruiting	Phase 3	630	Mirati Therapeutics Inc.INDUSTRY	35	Sep 22, 2026	clinicaltrials
NCT07100080	Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)	recruiting	Phase 2 / Phase 3	500	Bristol-Myers SquibbINDUSTRY	25	Sep 22, 2026	clinicaltrials
NCT07816380	A Phase III Study to Evaluate the Efficacy and Safety of JYP0322 in Previously Untreated ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer	not yet recruiting	Phase 3	216	Guangzhou JOYO Pharma Co., LtdINDUSTRY	0	Sep 22, 2026	clinicaltrials
NCT06745882	Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC	recruiting	Phase 2	318	H. Lee Moffitt Cancer Center and Research InstituteOTHER	1	Sep 21, 2026	clinicaltrials
NCT06318286	Study of Pembrolizumab Plus Chemotherapy With Lenvatinib for Malignant Pleural Mesothelioma(PENINSULA)	active not recruiting	Phase 2	25	Hyogo Medical UniversityOTHER	1	Sep 16, 2026	clinicaltrials
NCT07680764	A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)	recruiting	Phase 2	160	Bristol-Myers SquibbINDUSTRY	12	Sep 16, 2026	clinicaltrials
NCT07822542	A Study Evaluating HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer	not yet recruiting	Phase 3	448	Jiangsu Hansoh Pharmaceutical Co., Ltd.INDUSTRY	0	Sep 16, 2026	clinicaltrials
NCT06899126	Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer(DESTINY-Lung06)	recruiting	Phase 3	686	Daiichi SankyoINDUSTRY	23	Sep 15, 2026	clinicaltrials
NCT06236438	Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)(LIVIGNO-4)	recruiting	Phase 2 / Phase 3	840	AbbVieINDUSTRY	12	Sep 14, 2026	clinicaltrials
NCT04162015	A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma	active not recruiting	Phase 1	22	Memorial Sloan Kettering Cancer CenterOTHER	1	Sep 11, 2026	clinicaltrials
NCT04410796	Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers	recruiting	Phase 2	571	Memorial Sloan Kettering Cancer CenterOTHER	1	Sep 11, 2026	clinicaltrials
NCT06305754	Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)	active not recruiting	Phase 3	550	Merck Sharp & Dohme LLCINDUSTRY	19	Sep 11, 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
NCT01064648	Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma	active not recruiting	Phase 1 / Phase 2	117	National Cancer Institute (NCI)NIH	1	Sep 9, 2026	clinicaltrials
NCT04351555	A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer(NeoADAURA)	active not recruiting	Phase 3	358	AstraZenecaINDUSTRY	25	Sep 9, 2026	clinicaltrials
NCT03715933	Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas	recruiting	Phase 1	411	Inhibrx Biosciences, IncINDUSTRY	6	Sep 8, 2026	clinicaltrials
NCT04092283	Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer	active not recruiting	Phase 3	660	National Cancer Institute (NCI)NIH	2	Sep 8, 2026	clinicaltrials
NCT05789082	A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation(KRAScendo 170)	recruiting	Phase 1 / Phase 2	320	Hoffmann-La RocheINDUSTRY	18	Sep 8, 2026	clinicaltrials
NCT06119581	A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer(SUNRAY-01)	recruiting	Phase 3	1,264	Eli Lilly and CompanyINDUSTRY	29	Sep 8, 2026	clinicaltrials
NCT06561685	A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors	recruiting	Phase 1	340	Eli Lilly and CompanyINDUSTRY	6	Sep 8, 2026	clinicaltrials
NCT06793215	A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer(Krascendo 2)	recruiting	Phase 3	600	Hoffmann-La RocheINDUSTRY	28	Sep 8, 2026	clinicaltrials
NCT06862869	Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy	recruiting	—	800	Hoffmann-La RocheINDUSTRY	1	Sep 8, 2026	clinicaltrials
NCT02559778	Pediatric Precision Laboratory Advanced Neuroblastoma Therapy(PEDS-PLAN)	recruiting	Phase 2	500	Giselle ShollerOTHER	2	Sep 4, 2026	clinicaltrials
NCT05198830	Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer	active not recruiting	Phase 2	42	National Cancer Institute (NCI)NIH	1	Sep 4, 2026	clinicaltrials
NCT03178552	A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)(B-FAST)	active not recruiting	Phase 2 / Phase 3	1,000	Hoffmann-La RocheINDUSTRY	27	Sep 3, 2026	clinicaltrials
NCT04981509	Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer	recruiting	Phase 2	65	National Cancer Institute (NCI)NIH	1	Sep 2, 2026	clinicaltrials
NCT05862285	A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study(UmbrellaMAX)	recruiting	Phase 3	100	Hoffmann-La RocheINDUSTRY	15	Sep 2, 2026	clinicaltrials
NCT06632327	Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer	active not recruiting	Phase 3	37	Alliance for Clinical Trials in OncologyOTHER	1	Sep 2, 2026	clinicaltrials
NCT04538664	A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions(PAPILLON)	active not recruiting	Phase 3	308	Janssen Research & Development, LLCINDUSTRY	26	Aug 31, 2026	clinicaltrials
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
NCT06448754	Volrustomig Priming Regimens Exploratory Phase II Platform Study(eVOLVE-01)	active not recruiting	Phase 2	194	AstraZenecaINDUSTRY	14	Aug 31, 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 (226)

Linked publications (82)