ALK TKI (2nd generation) · small molecule

alectinib

17 active trials across 10 of our biomarkers, targeting ALK. 5 active approvals for a biomarker on marked.bio.

Also known as CH5424802, RO5424802, Alecensa.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

Therapy	Biomarker	Tumour	United States	European Union
alectinib FDA, 2015 metastatic, ALK-positive AA 11/12/2015 (after crizotinib), converted to regular approval 06/11/2017 with first-line use; current label 1.2: ALK-positive metastatic NSCLC. Source FDA, 2024 adjuvant after resection, ALK-positive, tumours >=4 cm or node-positive FDA approval 18/04/2024; label 1.1 (tumours >=4 cm or node positive). Source EU (EMA), 2017 ALK-positive advanced NSCLC previously treated with crizotinib MA 16/02/2017. First-line indication added by II/0001 (EC 18/12/2017), now its own row. Source EU (EMA), 2017 first line, ALK-positive advanced NSCLC II/0001, EC decision 18/12/2017. Source EU (EMA), 2024 adjuvant after complete resection, ALK-positive, high risk of recurrence II/0047, EC decision 06/06/2024. Source Alecensa	ALK fusion	NSCLC	Approved 2015	Approved 2017
In the US approval report ALEX vs crizotinib, 152 vs 151 patients PFS 25.7 months vs 10.4 months, HR 0.53 (0.38-0.73)Response 79% vs 72% Serious side effects 28%Stopped for side effects 11%Fatal 3.3% Trial details and side effects Patients first-line ALK-positive NSCLC (NCT02075840) Most common side effects constipation 34%, fatigue 26%, myalgia 23%, oedema 22% (152 patients) Later trial Brain metastases: response in the brain 81% vs 50% (21 vs 22 patients with measurable lesions). Notes US label rev. 08/2026. Source US approval report In the EU product information NP28761 and NP28673 single-arm, 87 and 138 patients Response 52% and 51% (40-65 and 42-60)Lasting 14.9 and 15.2 months Trial details and side effects Patients ALK-positive NSCLC after crizotinib (NCT01871805) Notes EU SmPC section 5.1 (NP28761 and NP28673, response-evaluable patients, independent review). Source EU product information In the EU product information ALEX vs crizotinib, 152 vs 151 patients PFS not reached (investigator) vs 11.1 months, HR 0.47 (0.34-0.65)Response 83% vs 76%OS 81.1 months vs 54.2 months, HR 0.78 (0.56-1.08), not significant Trial details and side effects Patients first-line ALK-positive NSCLC (NCT02075840) Most common side effects constipation 34%, fatigue 26%, myalgia 23%, oedema 22% (152 patients) Later trial Brain metastases: response in the brain 81% vs 50% (21 vs 22 patients with measurable lesions). Notes EU SmPC section 5.1 (ALEX, investigator-assessed PFS; final OS). Side effects from the US label. Source EU product information

Biomarkers

Biomarker	Active trials	All trials	Furthest active phase
ALK fusion	17	35	Phase 4
ROS1 fusion	4	4	Phase 3
BRAF V600E	3	6	Phase 2
NTRK1/2/3 fusion	2	2	Phase 2
BRCA1/2 mutation	1	2	Phase 2
EGFR exon 19 deletion / L858R	1	2	Phase 2
KRAS G12C	1	1	Phase 2
RET fusion or mutation	1	6	Phase 2
MSI-H / dMMR	0	1	–
PIK3CA activating mutation	0	1	–

Trials

17 of 37 trials shown

Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels

Recruiting Phase 4 University Medical Center Groningen Started 2022Primary completion 2025-12 NCT05525338

alectinib FDA EU

Documented ALK rearrangement based on an EMA approved test

ALK fusionStatus may be outdated, last updated 2024-05-13Drug Monitoring, Carcinoma, Non-Small-Cell Lung, Lung Cancer, Anaplastic Lymphoma Kinase Gene Mutation
Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

Active, not recruiting Phase 2/3 Medicine Invention Design Started 2026Primary completion 2026-11 NCT05987956

alectinib FDA EU

Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:

ALK fusionALK-Positive Non-Small Cell Lung Cancer (NSCLC)
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

Recruiting Phase 3 Nuvalent Started 2025Primary completion 2029-12 NCT06765109

neladalkibalectinib FDA EU

Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood

ALK fusionNon-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive
DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers

Recruiting Phase 2/3 Cancer Research UK Started 2023Primary completion 2029-10 NCT05770037

alectinib FDA EU

Confirmed diagnosis of an ALK-positive malignancy using an analytically validated next-generation sequencing method.

ALK fusionHaematological Malignancy, Malignant Neoplasm, Lymphoproliferative Disorders, Neoplasms by Histologic Type
A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)

Active, not recruiting Phase 3 Roche Started 2022Primary completion 2030-06 NCT05170204

alectinib FDA EUentrectinibdurvalumab

…rformed prior and within 42 days for Cohort A2 (ROS1 positive) and 50 days for Cohort A1 (ALK positive) of the first dose of concurrent chemoradiotherapy (cCRT) or sequential chemoradiotherapy…

ALK fusionROS1 fusionNon-Small Cell Lung Cancer
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

Active, not recruiting Phase 3 Roche Started 2018Primary completion 2023-06 NCT03456076

alectinib FDA EUcisplatinvinorelbinegemcitabinepemetrexedcarboplatin

Documented ALK-positive disease according to an FDA-approved and CE-marked test

ALK fusionCarcinoma, Non-Small-Cell Lung
Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa)

Not yet recruiting Phase 1/2 China Medical University Hospital Started 2026Primary completion 2029-01 NCT07560410

alectinib FDA EU

Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa)

ALK fusionBone Cancer
Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements

Recruiting Phase 1/2 Joshua Palmer Started 2024Primary completion 2028-02 NCT05987644

alectinib FDA EU

Confirmation of positive ALK rearrangement per local standard of care testing.

ALK fusionLung Cancer, NSCLC, Brain Metastases
Alectinib Pharmacokinetic in Patients With NSCLC

Recruiting Phase 1/2 Instituto Nacional de Cancerologia de Mexico Started 2022Primary completion 2026-12 NCT05713006

alectinib FDA EU

ALK rearrangements tested by FDA-approved tests (IHQ or FISH)

ALK fusionNon-small Cell Lung Cancer Stage IIIB, ALK Gene Mutation
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors

Active, not recruiting Phase 1/2 Roche Started 2021Primary completion 2032-02 NCT04774718

alectinib FDA EU

Histologically confirmed diagnosis of CNS or solid tumors with documented evidence of ALK gene fusions as assessed centrally through the use of the investigational F1CDx assay or based on pre-…

ALK fusionALK Fusion-positive Solid or CNS Tumors
Alectinib in Neo-adjuvant Treatment of Stage III NSCLC

Active, not recruiting Phase 2 Gruppo Oncologico Italiano di Ricerca Clinica Started 2021Primary completion 2024-12 NCT05015010

alectinib FDA EU

Documented ALK-positive disease according to an FDA-approved and CE-marked test.

ALK fusionStatus may be outdated, last updated 2024-08-09Non Small Cell Lung Cancer
ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma

Recruiting Phase 2 Hunan Province Tumor Hospital Started 2021Primary completion 2026-06 NCT05014464

crizotinib FDA EUalectinib FDA EUbrigatinib FDA EUlorlatinib FDA EUpemetrexedcarboplatinpaclitaxel

ALK fusion positive evaluated by IHC (ventana), NGS or FISH.

ALK fusionStatus may be outdated, last updated 2024-09-20Non-small Cell Lung Cancer
PLATFORM Study of Precision Medicine for Rare Tumors

Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020Primary completion 2026-07 NCT04423185

aumolertinibdacomitinib FDA EUalectinibcrizotinibpyrotinibimatinibniraparibpalbociclibvemurafenibsintilimabatezolizumab

when obtaining EGFR mutation, ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation, BRAF mutation, BRCA1/2 mu…

EGFR exon 19 deletion / L858RBRAF V600EBRCA1/2 mutationALK fusionROS1 fusionRare Tumor
A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)

Recruiting Phase 2 Roche Started 2020Primary completion 2026-11 NCT04302025

alectinibentrectinibvemurafenibcobimetinibpralsetinibatezolizumabSBRTChemotherapydivarasib

…on in ≥ 1% tumor cells as determined by Food and Drug Administration (FDA)-approved test, KRAS G12C mutation

KRAS G12CBRAF V600EALK fusionROS1 fusionRET fusion or mutationNTRK1/2/3 fusionNon-small Cell Lung Cancer
A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

Recruiting Phase 2 Centre Leon Berard Started 2020Primary completion 2026-10 NCT04116541

siremadlinribociclibcabozantinibalectinibregorafenibtrametinib FDA EUdabrafenib FDA EUAvapritinib

…r amplification and/or rearrangement of VEGFR1-3, TIE-2, KIT, RET, RAF1, BRAF (other than V600 mutations), CRAF, HRAS, PDGFR, FGFR1-2, FLT3 and/or CSFR1, and/or amplification of the ligands, an…

BRAF V600EALK fusionROS1 fusionNTRK1/2/3 fusionMalignant Solid Tumor
A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC

Active, not recruiting Phase 1/2 Massachusetts General Hospital Started 2017Primary completion 2029-01 NCT03202940

alectinib FDA EUcobimetinib

…tologically confirmed diagnosis of metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA)-approved fluorescence in-situ hy…

ALK fusionNon-small Cell Lung Cancer
A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)

Recruiting Phase 1 Memorial Sloan Kettering Cancer Center Started 2025Primary completion 2031-08 NCT07001384

alectinib FDA EUDuvelisib

Pathologically-confirmed diagnosis of ALK+ ALCL by WHO/ICC, classification procedures in use at the time of diagnosis.

ALK fusionAnaplastic Lymphoma Kinase, Anaplastic Large Cell Lymphoma
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)

Completed Phase 3 Roche Started 2024 NCT06624059

alectinib FDA EUcisplatincarboplatinpemetrexed

Documented ALK fusion

ALK fusionNon-Small Cell Lung Cancer
A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer

Completed Phase 3 Takeda Started 2019 NCT03596866

brigatinib FDA EUalectinib FDA EU

Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break-Apart fluorescence in situ hybridization (F…

ALK fusionALK+ Advanced NSCLC
A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

Completed Phase 3 Roche Started 2017 NCT03194893

alectinib FDA EUcrizotinib FDA EU

A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

ALK fusionRET fusion or mutationNeoplasms
A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

Completed Phase 3 Roche Started 2016 NCT02838420

alectinib FDA EUcrizotinib FDA EU

…age IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test.

ALK fusionAnaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer
Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib

Completed Phase 3 Roche Started 2015 NCT02604342

alectinib FDA EUdocetaxelpemetrexed

…age IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive.

ALK fusionNon-small Cell Lung Cancer
A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

Completed Phase 3 Roche Started 2014 NCT02075840

alectinib FDA EUcrizotinib FDA EU

…age IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test

ALK fusionNon-Small Cell Lung Cancer
CRAFT: The NCT-PMO-1602 Phase II Trial

Completed Phase 2 German Cancer Research Center Started 2021 NCT04551521

vemurafenib FDA EUcobimetinib FDA EUatezolizumab FDAtrastuzumabpertuzumabalectinibipatasertibinavolisib

Arm 1 (BRAF V600E/K): BRAF V600E/K mutation

BRAF V600EPIK3CA activating mutationALK fusionRET fusion or mutationMSI-H / dMMRMetastatic or Locally Advanced Malignancies
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

Terminated Phase 2 Roche Started 2021 NCT04644315

alectinib FDA EU

Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding lung cancer

ALK fusionNeoplasms, Colorectal Neoplasms, Melanoma, Pancreatic Neoplasms
Alectinib in Combination With Bevacizumab in ALK Positive NSCLC

Completed Phase 2 Instituto Nacional de Cancerologia de Mexico Started 2020 NCT03779191

alectinib FDA EUbevacizumab

Subjects with NSCLC with known ALK-rearrangement tested with FDA-approved test (IHQ or FISH).

ALK fusionALK Gene Rearrangement Positive, Non-Squamous Non-Small Cell Neoplasm of Lung
Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer

Terminated Phase 2 National Cancer Institute (NCI) Started 2019 NCT03737994

alectinib FDA EUbrigatinib FDA EUcarboplatinceritinib FDA EUcisplatincrizotinib FDA EUensartinib FDAlorlatinib FDA EUpemetrexed

Patients must have histologically or cytologically confirmed stage IV ALK-positive non-squamous non-small cell lung carcinoma (NSCLC) (includes M1a, M1b, M1c stage disease,…

ALK fusionLung Non-Squamous Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer

Terminated Phase 2 ETOP IBCSG Partners Foundation Started 2018 NCT03445000

alectinib

RET rearrangement detected by FISH, Nanostring or by parallel-sequencing on FFPE tumour tissue assessed loc…

RET fusion or mutationNon-small Cell Lung Cancer, Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Recurrent
Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity

Completed Phase 2 University College, London Started 2017 NCT02314481

atezolizumab FDAvemurafenib FDA EUalectinibtrastuzumab emtansine

Arm 2: Presence of BRAFV600 mutation

BRAF V600EALK fusionRET fusion or mutationNon-small Cell Lung Cancer
A Study of the Efficacy and Safety of Alectinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer

Completed Phase 2 Roche Started 2017 NCT03155009

alectinib FDA EU

…ken after progression on previous therapy showing presence of anaplastic lymphoma kinase (ALK) rearrangement, assessed by immunohistochemistry (IHC) and confirmed by fluorescence in situ hybridizati…

ALK fusionCarcinoma, Non-Small-Cell Lung
A Study of Alectinib in RET-rearranged Non-small Cell Lung Cancer or RET-mutated Thyroid Cancer

Terminated Phase 1/2 Dana-Farber Cancer Institute Started 2017 NCT03131206

alectinib FDA EU

… or cytologically confirmed diagnosis of metastatic (AJCC Stage IV) NSCLC that carries an ALK rearrangement with CNS metastases, as determined by FISH, RT-PCR, immunohistochemistry (IHC), or NGS vi…

ALK fusionRET fusion or mutationALK-positive Non-small Cell Lung Cancer (NSCLC), RET-positive Non-small Cell Lung Cancer (NSCLC), RET-positive Thyroid Cancer
Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer

Terminated Phase 1/2 Massachusetts General Hospital Started 2015 NCT02521051

alectinib FDA EUbevacizumab

Molecular confirmation of an ALK rearrangement.

ALK fusionNon-Small Cell Lung Cancer (NSCLC)
My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors

Completed Phase 2 Roche Started 2014 NCT02091141

trastuzumabpertuzumaberlotinibvemurafenib FDA EUcobimetinib FDA EUVismodegibalectinibatezolizumab FDA

…esting results from CLIA-certified laboratories (using tissue and/or blood) demonstrating BRAF V600 mutations a) For participants screened using a blood assay: obtain tissue-based testing r…

BRAF V600EALK fusionNeoplasms, Solid Tumors, Biliary Cancer, Salivary Cancer
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

Completed Phase 1/2 Roche Started 2013 NCT01871805

alectinib FDA EU

ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test

ALK fusionNon-Small Cell Lung Cancer
A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment

Completed Phase 1/2 Roche Started 2013 NCT01801111

erlotinibalectinib FDA EU

Documented ALK rearrangement based on Food and Drug Administration (FDA)-approved test

ALK fusionNon-Small-Cell Lung Carcinoma
A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC)

Completed Phase 1 Roche Started 2014 NCT02013219

alectinibatezolizumaberlotinib FDA EU

Participants in Stage 2 (Expansion) receiving erlotinib: i) sensitizing mutation in the EGFR gene and ii) consent to collection of tumor tissue samples before, during, and after trea…

EGFR exon 19 deletion / L858RALK fusionNon-Small Cell Lung Cancer
SMMART Adaptive Clinical Treatment (ACT) Trial

Withdrawn Early Phase 1 OHSU Knight Cancer Institute Started 2023 NCT05238831

alectinibalpelisibanastrozoleatezolizumabbevacizumab FDA EUcapecitabinecarboplatincobimetinibentrectiniberibulinfulvestrantpertuzumab

… least one prior line of therapy with a PARP inhibitor for triple negative disease with a BRCA1/2 mutation.

BRCA1/2 mutationAdvanced Breast Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Ovarian Carcinoma, Advanced Pancreatic Carcinoma

Approvals and pivotal results

Biomarkers

Sponsors

Trials