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 51–100 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 Fusion10
Ceritinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID1175 Updated results from ASCEND-1 trial assessing safety and activity of ceritinib in ALK rearranged locally advanced or metastatic NSCLC. 255 patients were enrolled and received at least one dose of ceri… (full text at CIViC) PMID 26973324 · Kim et al., 2016 · Open in CIViC	civic
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID1187 In the Phase I study PROFILE 1001 (NCT00585195), a recommended crizotinib dose of 250 mg twice daily for 28 day cycles was established. Among 1,500 advanced NSCLC patients who were screened for ALK-re… (full text at CIViC) PMID 20979469 · Kwak et al., 2010 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID1198 This two arm Phase III study named PROFILE 1007 (NCT00932893) was performed to assess crizotinib vs. established chemotherapy in non-small cell lung cancer patients positive for ALK rearrangement (ass… (full text at CIViC) PMID 23724913 · Shaw et al., 2013 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID1199 This phase 3 trial named PROFILE 1014 (NCT01154140) compared crizotinib to established chemotherapy in first-line treatment for this disease. The study consisted of 343 patients with advanced or metas… (full text at CIViC) PMID 25470694 · Solomon et al., 2014 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID1200 This retrospective study of patients from the PROFILE 1001 and 1005 studies of crizotinib in advanced ALK-rearranged NSCLC assessed the potential benefit of crizotinib beyond progressive disease (CBPD… (full text at CIViC) PMID 24478318 · Ou et al., 2014 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID1201 This prospective Phase III study named Profile 1014 on NSCLC ALK-rearranged patients assessed intracranial disease control rate (IC-DCR) in the subset of patients entering the study with preexisting t… (full text at CIViC) PMID 27022118 · Solomon et al., 2016 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID1419 In a retrospective study comparing survival outcomes in a subgroup of 82 ALK-positive crizotinib-treated patients enrolled in a phase 1 clinical trial (NCT00585195), crizotinib therapy was associated … (full text at CIViC) PMID 21933749 · Shaw et al., 2011 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID1577 A phase-3 clinical trial evaluated 347 patients with ALK-positive lung cancer. The study compared crizotinib treatment (n=173) with chemotherapy treatment of either pemetrexed or docetaxel (n=174). … (full text at CIViC) PMID 26466010 · 2015 · Open in CIViC	civic
Alectinib + CrizotinibSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	5	accepted	EID4858 In a randomized, open-label phase 3 trial 303 patients with ALK-positive, previously untreated NSCLC (including asympt. CNS disease) were randomized to reiceive either Alectinib or Crizotinib. During … (full text at CIViC) PMID 28586279 · Peters et al., 2017 · Open in CIViC	civic
Lorlatinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID7286 In a phase 2 trial, patients with NSCLC with ALK fusion received lorlatinib. In treatment-naive patients, ORR was 90.0% In patients with at least one previous ALK tyrosine kinase inhibitor, ORR were a… (full text at CIViC) PMID 30413378 · Solomon et al., 2018 · Open in CIViC	civic
ALK Mutation1
Ceritinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID1237 In a phase 1 clinical trial (NCT01283516) 130 patients with advanced cancers all harboring ALK alterations were treated with ceritinib. Of 114 NSCLC patients treated with at least 400 mg/daily ceriti… (full text at CIViC) PMID 24670165 · Shaw et al., 2014 · Open in CIViC	civic
ALK I11714
Ceritinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	4	accepted	EID1284 The MGH056-1 cell line was derived from an NSCLC patient with ALK-rearrangement who had progressed on crizotinib and then on alectinib. the cell line was also resistant to crizotinib and alectinib, an… (full text at CIViC) PMID 25228534 · Katayama et al., 2014 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID1368 A 51 year old female never smoker was diagnosed with stage IV NSCLC with liver metastases, and had adverse response to crizotinib treatment, after which she responded to alectinib until disease progre… (full text at CIViC) PMID 25736571 · Ou et al., 2015 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER
ALK F1245C + ALK Fusion2
Ceritinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID1338 A 52 year old male never smoker was diagnosed with stage IV NSCLC adenocarcinoma and was treated with chemotherapy with eventual disease progression. He tested positive for ALK rearrangement via break… (full text at CIViC) PMID 26775591 · Kodityal et al., 2016 · Open in CIViC	civic
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID1339 A 52 year old with a non-smoking history was diagnosed with stage IV NSCLC-adenocarcinoma and treated with chemotherapy. Upon disease progression, the initial diagnostic biopsy tested positive for AL… (full text at CIViC) PMID 26775591 · Kodityal et al., 2016 · Open in CIViC	civic
ALK V1180L + ALK Fusion2
Ceritinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID1289 Passaging of the alectinib sensitive EML4-ALK containing H3122 NSCLC cell line with increasing levels of alectinib resulted in an alectinib resistant derivative of this cell line named H3122 CHR-A1. A… (full text at CIViC) PMID 25228534 · Katayama et al., 2014 · Open in CIViC	civic
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Resistance	2	accepted	EID1288 The alectinib resistant cell line H3122 CHR-A1 was generated by culturing of the EML4-ALK (variant 1) containing cell line H3122 with increasing levels of alectinib. Molecular characterization of H312… (full text at CIViC) PMID 25228534 · Katayama et al., 2014 · Open in CIViC	civic
ALK e6::e203
Ceritinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID1340 Ceritinib was 28x more potent (GI50 3.8nM) than crizotinib (GI50 107nM) at inhibiting growth of H2228, an NSCLC cell line which harbors the EML4-ALK variant 3a/3b. SCID mice xenografted with H2228 we… (full text at CIViC) PMID 24675041 · Friboulet et al., 2014 · Open in CIViC	civic
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	4	accepted	EID1193 In a set of 31 patients with NSCLC, RT-PCR was performed to test for known EML4-ALK variants. Five patients tested positive for the 3a/3b EML4-ALK variant. Of these, 4 had partial response (PR), and… (full text at CIViC) PMID 20979469 · Kwak et al., 2010 · Open in CIViC	civic
〃	Lung Non-Small Cell Carcinoma
ALK L1196M + ALK Fusion2
Ceritinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	accepted	EID1341 The crizotinib-resistant MGH045 cell line with EML4-ALK L1196M was treated with crizotinib or ceritinib. In nude mice with MGH045 xenografts, tumor response to crizotinib did not differ appreciably fr… (full text at CIViC) PMID 24675041 · Friboulet et al., 2014 · Open in CIViC	civic
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Resistance	4	accepted	EID442 The L1196M mutation in the EML4-ALK fusion was found to confer resistance to crizotinib in Ba/F3 cells. PMID 22277784 · Katayama et al., 2012 · Open in CIViC	civic
ALK G1269A + ALK Fusion1
Ceritinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID1342 The NSCLC cell line MGH021-4, harboring SQSTM1-ALK G1269A, was 6 times more sensitive to ceritinib (80nM GI50) than crizotinib (500 nM) in proliferation assays and caused notable reductions in phospho… (full text at CIViC) PMID 24675041 · Friboulet et al., 2014 · Open in CIViC	civic
ALK S1206Y + ALK Fusion2
Ceritinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID1343 Ba/F3 cells expressing the EML4-ALK S1206Y variant were treated with ceritinib, and survival GI50 value of 1.5 nM was obtained, which compares favorably with GI50 of 1.7 for the highly ceritinib sensi… (full text at CIViC) PMID 24675041 · Friboulet et al., 2014 · Open in CIViC	civic
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Resistance	4	accepted	EID443 The S1206Y mutation in the EML4-ALK fusion was found to confer resistance to crizotinib in Ba/F3 cells. PMID 22277784 · Katayama et al., 2012 · Open in CIViC	civic
ALK G1202R + ALK Fusion2
Ceritinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Resistance	4	accepted	EID1345 Ba/F3 cells expressing EML4-ALK variant 1 with ALK G1202R mutation were assessed for ceritinib sensitivity. Crizotinib was shown to confer significantly more potency than ceritinib (43-fold decrease i… (full text at CIViC) PMID 24675041 · Friboulet et al., 2014 · Open in CIViC	civic
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Resistance	4	accepted	EID441 The G1202R mutation in the EML4-ALK fusion was found to confer resistance to crizotinib in Ba/F3 cells. PMID 22277784 · Katayama et al., 2012 · Open in CIViC	civic
ALK T1151dup + ALK Fusion1
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	4	accepted	EID444 A lung adenocarcinoma patient responded to crizotinib treatment for 12 months, after which the cancer relapsed and sequencing of the ALK tyrosine kinase domain revealed a 1151insT mutation. This mutat… (full text at CIViC) PMID 22277784 · Katayama et al., 2012 · Open in CIViC	civic
ALK L1152R + ALK Fusion1
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	4	accepted	EID763 Case-report of a patient with an acquired EML4::ALK L1152R mutation and resistance to crizotinib treatment. The L1152R variant was not present in the pre-crizotinib sample. A cell line model also show… (full text at CIViC) PMID 21791641 · Sasaki et al., 2011 · Open in CIViC	civic
ALK G1269A + ALK Fusion2
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	4	accepted	EID764 This study analyzed patients with non small cell lung cancer (NSCLC) who were positive for EML4-ALK fusions (ALK+) and progressed on crizotinib monotherapy. One ALK+ patient harbored the common E6;A20… (full text at CIViC) PMID 22235099 · Doebele et al., 2012 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID765 2 out of 7 patients with an acquired resistance to crizotinib had a G1269A mutation. One of these patients also harbored a L1196M mutation. In vitro follow-up showed reduced crizotinib-induced ALK dep… (full text at CIViC) PMID 23344087 · Kim et al., 2013 · Open in CIViC	civic
ALK Amplification + ALK Fusion3
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID766 This study analyzed patients with non small cell lung cancer (NSCLC) who were positive for EML4-ALK fusions (ALK+) and progressed on crizotinib monotherapy. One out of 11 patients with acquired crizot… (full text at CIViC) PMID 22235099 · Doebele et al., 2012 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID767 One patient with ALK-rearranged non-small cell lung cancer and an acquired resistance to crizotinib showed new ALK amplification (4.1 fold increase compared to pre-crizotinib specimen as measured by F… (full text at CIViC) PMID 23344087 · Kim et al., 2013 · Open in CIViC	civic
〃	Lung Non-Small Cell Carcinoma
ALK C1156Y + ALK L1198F + ALK Fusion1
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	4	accepted	EID844 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 e20::e203
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	2	accepted	EID1189 In the PROFILE 1001 study, from 31 NSCLC tumors positive for ALK fusions with sufficient material for RT-PCR aided exon breakpoint identification, 1 case of EML4-ALK variant 2 (EML4 exon 20 fused to A… (full text at CIViC) PMID 20979469 · Kwak et al., 2010 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID1196 EML4-ALK variants v1 (E13;A20), v2 (E20;A20), v3a (E6;A20) and v3b (E6ins33;A20) were expressed in Ba/F3 cells using retrovirus. While all constructs rendered Ba/F3 cells IL3-independant, marked diff… (full text at CIViC) PMID 22912387 · Heuckmann et al., 2012 · Open in CIViC	civic
Alvespimycin + CrizotinibCombination
ALK Fusion3
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	4	accepted	EID1207 In the PROFILE 1001 study of crizotinib in 82 patients with ALK-rearranged NSCLC, 31 patients with sufficient tumor material were tested using RT-PCR for the presence of certain EML4-ALK variants. 13… (full text at CIViC) PMID 20979469 · Kwak et al., 2010 · Open in CIViC	civic
Alvespimycin + CrizotinibCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID1206 Transduction of Ba/F3 cells with EML4-ALK variant 1 causes IL3 independent growth. Incubation of EML4-ALK variant 1 transduced Ba/F3 cells with Hsp90 inhibitor 17-DMAG caused cell death that was rever… (full text at CIViC) PMID 22912387 · Heuckmann et al., 2012 · Open in CIViC	civic
Crizotinib
ALK F1174L + ALK Fusion1
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Resistance	3	accepted	EID33 Ba/F3 cells expressing the EML4-ALK fusion containing an F1174L mutation were more resistant to crizotinib treatment than Ba/F3 cells expressing EML4-ALK without this mutation. PMID 21030459 · Sasaki et al., 2010 · Open in CIViC	civic
ALK C1156Y + ALK Fusion3
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Resistance	4	accepted	EID1346 EML4-ALK variant 3 containing NSCLC cell line H2228 xenografts in SCID beige mice were treated with increasing doses of crizotinib up to 100 mg/kg per day by oral gavage. At approximately 40 days tumo… (full text at CIViC) PMID 24675041 · Friboulet et al., 2014 · Open in CIViC	civic
Ceritinib + Crizotinib + LuminespibSequential	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID841 In this case report, a patient with metastatic, ALK-rearranged NSCLC with C1156Y mutation had tumor progression under sequential treatment with first crizotinib, then ceritinib and finally AUY922. Sub… (full text at CIViC) PMID 26698910 · Shaw et al., 2016 · Open in CIViC	civic

ALK e2::e201
Crizotinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	E	Supports Sensitivity Response	4	accepted	EID1190 Multiplex RT-PCR to detect in-frame fusions of EML4 to ALK was performed on total RNA from 253 lung adenocarcinomas, and 9 samples were found to contain such fusions, one of which was a novel fusion c… (full text at CIViC) PMID 18927303 · Takeuchi et al., 2008 · Open in CIViC	civic
ALK I1171N + ALK Fusion1
Alectinib + CrizotinibSequential	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID1483 Case study describes a female (age 58) never-smoker presenting with stage IV NSCLC with an ALK rearrangement (confirmed by fish). Patient was treated with crizotinib (partial response) and alectinib (… (full text at CIViC) PMID 25393796 · Ou et al., 2014 · Open in CIViC	civic
ALK I1171S + ALK Fusion1
Alectinib + CrizotinibSequential	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID1484 Case study describes a caucasian male (age 38) never smoker presenting with stage IV non-small cell lung cancer with an ALK rearrangement. Patient was given crizotinib and exhibited a partial response… (full text at CIViC) PMID 25393796 · Ou et al., 2014 · 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

health-canada-dpdRegulatory50 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
Erlotinib	CA Health Canada	—	Marketed in Canada as APO-ERLOTINIB (DIN 02461870) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 22, 2017	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as APO-ERLOTINIB (DIN 02461889) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 22, 2017	health-canada-dpd
Erlotinib	CA Health Canada	—	Marketed in Canada as APO-ERLOTINIB (DIN 02461862) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed

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 1–50 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
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 29, 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 29, 2026	clinicaltrials
NCT06448754	Volrustomig Priming Regimens Exploratory Phase II Platform Study(eVOLVE-01)	active not recruiting	Phase 2	194	AstraZenecaINDUSTRY	14	Sep 29, 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 29, 2026	clinicaltrials
NCT07846358	This is a Multicenter, Open-label, Phase I/II Study to Explore the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of GFH276 in Patients With Advanced NSCLC Harboring a RAS Mutation.(GFH276X1203)	not yet recruiting	Phase 1 / Phase 2	84	Genfleet Therapeutics (Shanghai) Inc.INDUSTRY	0	Sep 29, 2026	clinicaltrials
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
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
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
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

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

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)