Summary
Crizotinib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Cancer. ClinicalTrials.gov lists 8 registered trials linking Crizotinib to Cancer: 2 are currently recruiting; 2 are active or not yet recruiting; 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT06140836). The largest enrolment is 840 participants (NCT05384626). Registration activity spans 2009 to 2023. The literature layer holds 17 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 systematic review, 3 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2024 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Cancer ranks 1226 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous regression is rare (<0.5% of cases); 5-year survival without treatment: <5% for advanced NSCLC; ~20% for stage I-II with surgery.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 75.0 (trials 25.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 2 recruiting, 2 active / not yet recruiting, 3 completed, 1 other |
| Linked publications | 17 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 3 randomised controlled trial publications, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| 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) 2023 | active, not recruiting | Phase 3 | 190 |
| NCT02568267 | Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) 2015 | active, not recruiting | Phase 2 | 534 |
| NCT02336451 | A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges 2015 | completed | Phase 2 | 156 |
| NCT01744652 | Dasatinib and Crizotinib in Advanced Cancer 2013 | completed | Phase 1 | 62 |
| NCT02074878 | CRIZENT: Crizotinib and Sunitinib in Metastatic Breast Cancer 2014 | terminated | Phase 1 | 3 |
| NCT00939770 | Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma 2009 | completed | PHASE1, PHASE2 | 122 |
| NCT03947385 | Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions 2019 | recruiting | PHASE1, PHASE2 | 336 |
| NCT05384626 | A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1) 2022 | recruiting | PHASE1, PHASE2 | 840 |
Published literature
- Clinical trial publication Long-Term Efficacy and Safety of Taletrectinib in Patients With ROS1+ Non-Small Cell Lung Cancer: Results From the Phase II TRUST-I StudyLi W, Zhang Y, Fan H et al. · Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026 · PMID 42013573
- Clinical trial publication Phase 1/2 Study of Crizotinib in Children With Relapsed/Refractory ALK-Positive Anaplastic Large Cell Lymphoma or Neuroblastoma in JapanMori T, Kada A, Osumi T et al. · Cancer science · 2026 · PMID 41457564
- Clinical trial publication Lorlatinib in Tyrosine Kinase Inhibitor-Naive Advanced ROS1-Positive Non-Small Cell Lung Cancer: A Phase 2 Nonrandomized Clinical TrialAhn BC, Kim YJ, Lee Y et al. · JAMA oncology · 2026 · PMID 41296331
- Clinical trial publication Alectinib versus crizotinib in previously untreated ALK-positive advanced non-small cell lung cancer: final overall survival analysis of the phase III ALEX studyPeters S, Camidge R, Dziadziuszko R et al. · Annals of oncology : official journal of the European Society for Medical Oncology · 2026 · PMID 41110693
- Cochrane review Optimizing treatment and sequencing strategies for maximal survival and net health benefits in ALK-positive NSCLC: a systematic review and reconstructed individual patient data meta-analysisZhao M, Li J, Jiang Y et al. · BMC cancer · 2026 · PMID 41906076
- Cochrane review Association between ALK tyrosine kinase inhibitor and the risk of interstitial lung disease and pneumonitis in non-small cell lung cancer patients: a systematic reviewSun S, Zhang R, Tan S et al. · BMC cancer · 2026 · PMID 41578213
- Meta-analysis A Systematic Review and Meta-analysis of Clinical Trials in ALK-positive Non-small Cell Lung CancerBasmajian K, Stepanyan Z, Sarkissian S · Anticancer research · 2026 · PMID 42373241
- Systematic review Modulation of Oncogenic NOTCH Signaling in Highly Aggressive Malignancies by Targeting the γ-Secretase Complex: A Systematic ReviewMartínez-Gascueña P, Nueda ML, Baladrón V · Cells · 2026 · PMID 41827901
- Clinical trial publication Real-world treatment patterns and subsequent treatment effectiveness following frontline brigatinib in the ALTA-1L trialAhn MJ, Delmonte A, Ghosh S et al. · Future oncology (London, England) · 2025 · PMID 41410381
- Cochrane review Nutritional status, body composition and chemotherapy dosing in children and young people with cancer: a systematic review by the SIOP nutrition networkLovell AL, Makamo N, Veal GJ et al. · British journal of cancer · 2025 · PMID 40571762
- Cochrane review Efficacy and safety of taletrectinib for treatment of ROS1 positive non-small cell lung cancer: A systematic reviewKhan I, Sahar A, Numra S et al. · Expert opinion on pharmacotherapy · 2025 · PMID 40170301
- Meta-analysis Health-related quality of life among anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) patients treated with first- and next-generation ALK tyrosine kinase inhibitors (TKIs): a systematic review and meta-analysisHuang Y, Chu Q, Wang J et al. · Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025 · PMID 41313568
- Meta-analysis Cardiovascular toxicity of anaplastic lymphoma kinase inhibitors for patients with non-small cell lung cancer: a network meta-analysisCai JQ, Wang YM, Lin X et al. · Future oncology (London, England) · 2025 · PMID 39400073
- Randomized controlled trial Activity of Brigatinib in Patients With Crizotinib-Resistant ALK-positive Non-Small-Cell Lung Cancer According to ALK Fusion and Mutation StatusBazhenova L, Hodgson JG, Camidge DR et al. · Clinical lung cancer · 2025 · PMID 40582920
- Randomized controlled trial First-Line Lorlatinib Versus Crizotinib in Asian Patients With Advanced ALK-Positive NSCLC: Five-Year Outcomes From the CROWN StudyWu YL, Kim HR, Soo RA et al. · Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2025 · PMID 40024442
- Cochrane review Correlation between ALK+ non-small cell lung cancer targeted therapy and thrombosis: a systematic review and network meta-analysisQi Y, Wang X, Guo T et al. · BMJ open · 2024 · PMID 39349372
- Randomized controlled trial Final Overall Survival Analysis of S1500: A Randomized, Phase II Study Comparing Sunitinib With Cabozantinib, Crizotinib, and Savolitinib in Advanced Papillary Renal Cell CarcinomaBarata P, Tangen C, Plets M et al. · Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 · PMID 39255440
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Crizotinib approved for Cancer?
Crizotinib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Crizotinib in clinical trials for Cancer?
ClinicalTrials.gov lists 8 registered trials linking Crizotinib to Cancer: 2 are currently recruiting; 2 are active or not yet recruiting; 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT06140836). The largest enrolment is 840 participants (NCT05384626). Registration activity spans 2009 to 2023.
What does the evidence show for Crizotinib in Cancer?
Crizotinib has both completed registered trials and synthesis-level publications linked to Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.