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 151–200 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
NCT02152631	A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer(JUNIPER)	active not recruiting	Phase 3	453	Eli Lilly and CompanyINDUSTRY	21	Feb 6, 2026	clinicaltrials
NCT04223596	Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients(CUBIK)	active not recruiting	Phase 2	33	Fundación GECPOTHER	1	Feb 4, 2026	clinicaltrials
NCT04339218	Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma(CRYOMUNE)	recruiting	Phase 3	214	Institut BergoniéOTHER	1	Jan 30, 2026	clinicaltrials
NCT05502237	Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer(STAR-121)	active not recruiting	Phase 3	1,021	Gilead SciencesINDUSTRY	23	Jan 30, 2026	clinicaltrials
NCT07005336	A Study to Compare Uliledlimab Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer	active not recruiting	Phase 2	150	TJ Biopharma Co., Ltd.INDUSTRY	1	Jan 30, 2026	clinicaltrials
NCT07365410	Furmonertinib 160mg vs 80mg + Chemotherapy in EGFR-Mutated NSCLC With Brain Metastases: Efficacy and Safety Study	not yet recruiting	Phase 2	60	Tianjin Medical University Cancer Institute and HospitalOTHER	1	Jan 26, 2026	clinicaltrials
NCT05740943	Induction Lorlatinib in Stage III Non-small Cell Lung Cancer	active not recruiting	Phase 2	48	Guangdong Provincial People's HospitalOTHER	1	Jan 20, 2026	clinicaltrials
NCT06576635	LUNG-05: Investigating Chemotherapy Effectiveness for Non-Small Cell Lung Cancer (NSCLC) Metastatic Patients(LUNG-05)	recruiting	N/A	29	University of Illinois at ChicagoOTHER	1	Jan 20, 2026	clinicaltrials
NCT02411448	A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)(RELAY)	active not recruiting	Phase 3	545	Eli Lilly and CompanyINDUSTRY	14	Jan 16, 2026	clinicaltrials
NCT04367311	Adjuvant Treatment With Cisplatin-based Chemotherapy Plus Concomitant Atezolizumab in Patients With Stage I (Tumors ≥ 4cm), IIA, IIB, and Select Stage III [Any T1-3 N1-2 and T4N0-2] Resected Non-small Cell Lung Cancer (NSCLC) and the Clearance of Circulating Tumor DNA (ctDNA)	active not recruiting	Phase 2	100	Nasser HannaOTHER	1	Jan 2, 2026	clinicaltrials
NCT02201992	Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)	active not recruiting	Phase 3	166	ECOG-ACRIN Cancer Research GroupNETWORK	3	Dec 19, 2025	clinicaltrials
NCT04966663	Using ctDNA to Determine Therapies for Lung Cancer(ctDNA Lung RCT)	recruiting	Phase 2	66	University Health Network, TorontoOTHER	1	Dec 18, 2025	clinicaltrials
NCT06908993	Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated(COMET)	recruiting	Phase 3	133	Intergroupe Francophone de Cancerologie ThoraciqueOTHER	1	Dec 17, 2025	clinicaltrials
NCT04925609	Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors(Briga-PED)	recruiting	Phase 1 / Phase 2	65	Princess Maxima Center for Pediatric OncologyOTHER	2	Dec 5, 2025	clinicaltrials
NCT07256509	A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer	not yet recruiting	Phase 2	120	CSPC Megalith Biopharmaceutical Co.,Ltd.INDUSTRY	0	Dec 5, 2025	clinicaltrials
NCT03052608	A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC	active not recruiting	Phase 3	296	PfizerINDUSTRY	23	Nov 25, 2025	clinicaltrials
NCT05117476	A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors(MICA)	active not recruiting	Phase 1	440	Cullinan Therapeutics Inc.INDUSTRY	4	Nov 24, 2025	clinicaltrials
NCT05770037	DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers(DETERMINE)	recruiting	Phase 2 / Phase 3	30	Cancer Research UKOTHER	1	Nov 24, 2025	clinicaltrials
NCT05770544	DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-Positive Cancers.(DETERMINE)	recruiting	Phase 2 / Phase 3	30	Cancer Research UKOTHER	1	Nov 24, 2025	clinicaltrials
NCT05200481	Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)(MP-ALK)	active not recruiting	Phase 2	110	Intergroupe Francophone de Cancerologie ThoraciqueOTHER	1	Nov 17, 2025	clinicaltrials
NCT03707938	Local Consolidative Therapy and Brigatinib in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer	active not recruiting	Phase 1	35	M.D. Anderson Cancer CenterOTHER	1	Nov 3, 2025	clinicaltrials
NCT04194944	A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer(LIBRETTO-431)	active not recruiting	Phase 3	261	Eli Lilly and CompanyINDUSTRY	26	Oct 21, 2025	clinicaltrials
NCT00977470	Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations	active not recruiting	Phase 2	76	Massachusetts General HospitalOTHER	1	Oct 15, 2025	clinicaltrials
NCT02767804	eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients	active not recruiting	Phase 3	290	Xcovery Holdings, Inc.INDUSTRY	20	Oct 14, 2025	clinicaltrials
NCT07199959	Study on the Mechanism of Acquired Resistance of Entrectinib	recruiting	—	38	Fudan UniversityOTHER	1	Sep 30, 2025	clinicaltrials
NCT07154368	JYP0322 Versus Platinum Based Doublet Chemotherapy in ROS1 Positive Patients Previously Treated With ROS1-TKIs.	not yet recruiting	Phase 3	207	Guangzhou JOYO Pharma Co., LtdINDUSTRY	0	Sep 19, 2025	clinicaltrials
NCT05442060	To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer(EGFR)	recruiting	Phase 2	60	OBI Pharma, IncINDUSTRY	1	Aug 3, 2025	clinicaltrials
NCT04341181	ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling(ProTarget)	recruiting	Phase 2	300	Ulrik LassenOTHER	1	Jul 25, 2025	clinicaltrials
NCT04136535	Pemetrexed and Carboplatin With or Without Anlotinib Hydrochloride for Osimertinib-resistant Non-squamous NSCLC(PCA)	recruiting	Phase 2	105	Fudan UniversityOTHER	1	Jul 22, 2025	clinicaltrials
NCT05116462	Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer	active not recruiting	Phase 3	506	Innovent Biologics (Suzhou) Co. Ltd.INDUSTRY	1	Jun 26, 2025	clinicaltrials
NCT05180799	A Phase 1/2 Study of BA3071 in Patients With Solid Tumors	active not recruiting	Phase 1 / Phase 2	320	BioAtla, Inc.INDUSTRY	2	Jun 15, 2025	clinicaltrials
NCT04533451	Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer	active not recruiting	Phase 2	101	Alliance for Clinical Trials in OncologyOTHER	1	Jun 13, 2025	clinicaltrials
NCT03800134	A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer(AEGEAN)	active not recruiting	Phase 3	825	AstraZenecaINDUSTRY	28	Jun 11, 2025	clinicaltrials
NCT06754644	A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC	recruiting	Phase 3	808	Qilu Pharmaceutical Co., Ltd.INDUSTRY	1	Jun 10, 2025	clinicaltrials
NCT06969612	A Study on the Efficacy and Safety of Golidocitinib Combined With Tislelizumab and Chemotherapy as First-line Treatment for Advanced NSCLC	recruiting	Phase 1	21	Peking University Cancer Hospital & InstituteOTHER	1	Jun 6, 2025	clinicaltrials
NCT06943820	AK129 Combination Therapy for Advanced Solid Tumors	recruiting	Phase 1 / Phase 2	230	AkesoINDUSTRY	1	Jun 3, 2025	clinicaltrials
NCT06082635	TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC)	active not recruiting	Phase 3	321	Shenzhen TargetRx Co., Ltd.INDUSTRY	1	May 18, 2025	clinicaltrials
NCT06659042	Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer	recruiting	Phase 2	32	Shanghai Chest HospitalOTHER	1	May 18, 2025	clinicaltrials
NCT06829459	A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIs	recruiting	Phase 3	350	Shanghai JMT-Bio Inc.INDUSTRY	1	Apr 8, 2025	clinicaltrials
NCT05255302	De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction(DIAL)	recruiting	Phase 2 / Phase 3	1,360	Intergroupe Francophone de Cancerologie ThoraciqueOTHER	1	Apr 1, 2025	clinicaltrials
NCT06893354	Explore the Mechanisms Underlying Disease Resistance and Potential Primary Resistance Mechanism of Induction Therapy Lorlatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Positive Mutation Revealed by Single-cell RNA Sequencing and Spatial Transcriptomics	not yet recruiting	Phase 4	20	The First Affiliated Hospital of Guangzhou Medical UniversityOTHER	0	Mar 25, 2025	clinicaltrials
NCT06876675	LORLATINIB-related HYPERLIPIDEMIA in ALK+ Non-Small Cell Lung Cancer	enrolling by invitation	—	167	Peking University Third HospitalOTHER	1	Mar 14, 2025	clinicaltrials
NCT06858410	Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma	not yet recruiting	Phase 3	36	Guangdong Association of Clinical TrialsOTHER	0	Mar 5, 2025	clinicaltrials
NCT05281406	Additional Chemotherapy for EGFRm Patients with the Continued Presence of Plasma CtDNA EGFRm At Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)	recruiting	Phase 2	50	Goethe UniversityOTHER	1	Feb 21, 2025	clinicaltrials
NCT03944772	Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)(ORCHARD)	active not recruiting	Phase 2	247	AstraZenecaINDUSTRY	9	Jan 30, 2025	clinicaltrials
NCT05504278	Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation	recruiting	Phase 1	144	Innovent Biologics (Suzhou) Co. Ltd.INDUSTRY	1	Jan 27, 2025	clinicaltrials
NCT06758557	A Study to Evaluate the Safety and Efficacy of HB0025 Injection in Patients With Advanced Solid Tumor	recruiting	Phase 1 / Phase 2	282	Huabo Biopharm Co., Ltd.INDUSTRY	1	Jan 23, 2025	clinicaltrials
NCT06704620	Study of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Cancer	not yet recruiting	Phase 3	430	Tianjin Medical University Cancer Institute and HospitalOTHER	1	Dec 16, 2024	clinicaltrials
NCT04956692	Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)	active not recruiting	Phase 3	531	Merck Sharp & Dohme LLCINDUSTRY	16	Dec 3, 2024	clinicaltrials
NCT06709274	Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC(MOTION-NSCLC)	not yet recruiting	N/A	342	Guangdong Association of Clinical TrialsOTHER	1	Nov 29, 2024	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)