30 completed, 18 recruiting, 12 active not recruiting, 5 terminated. 40 Phase 2, 18 Phase 1, 13 Phase 3, 1 Early Phase 1, 1 Not applicable.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Molecularly Stratified Trial for Newly Diagnosed Infant-Type Hemispheric Glioma Alectinib, Entrectinib, Surgery - Infant-Type Hemispheric Glioma | Phase 2 | Not yet recruiting | St. Jude Children's Research Hospital | 50 | 2026-11-01 | 2026-11-04 |
| Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa) Alectinib - Bone Cancer | Phase 1 / Phase 2 | Not yet recruiting | China Medical University Hospital | 10 | 2026-05-15 | 2026-05-11 |
| Multi Omics Molecular Characteristics and Immunophenotyping of Lung Signet Ring Cell Carcinoma Patients with specific TIME subtype and ALK fusion mutations (confirmed via RNA-seq and OncoKB annotation) will receive tyrosine kinase inhibitors (TKIs, e.g., alectinib or crizotinib) as first-line - Signet Ring Cell Carcinoma of the Lung | Recruiting | First People's Hospital of Hangzhou | 39 | 2025-09-01 | 2025-10-03 | |
| A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL) Alectinib, Duvelisib - Anaplastic Lymphoma Kinase, Anaplastic Large Cell Lymphoma | Phase 1 | Recruiting | Memorial Sloan Kettering Cancer Center | 30 | 2025-08-08 | 2026-05-26 |
| Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC Neladalkib (NVL-655), Alectinib - Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive | Phase 3 | Recruiting | Nuvalent Inc. | 450 | 2025-07-17 | 2026-09-30 |
| Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy Alectinib - Carcinoma, Non-Small-Cell Lung | Recruiting | Hoffmann-La Roche | 800 | 2025-04-30 | 2026-11-05 | |
| Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS Albumin-Bound Paclitaxel, Epirubicin, Gemcitabine - Rare Tumour | Phase 2 | Not yet recruiting | Peking University Shenzhen Hospital | 200 | 2025-01-01 | 2024-11-18 |
| A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC) Alectinib, Cisplatin, Carboplatin - Non-Small Cell Lung Cancer | Phase 3 | Completed | Hoffmann-La Roche | 11 | 2024-11-18 | 2026-08-19 |
| Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC Osimertinib, Alectinib, TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy - Non-Small Cell Lung Cancer | Not applicable | Not yet recruiting | Guangdong Association of Clinical Trials | 342 | 2024-11-01 | 2024-11-29 |
| ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer Alectinib, Brigatinib, Lorlatinib 100 mg - NSCLC Stage IV, Sex Disorder | Unknown | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | 80 | 2024-08-05 | 2024-08-09 | |
| Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements Alectinib, Stereotactic Radiosurgery - Lung Cancer, NSCLC | Phase 1 / Phase 2 | Recruiting | Joshua Palmer | 56 | 2024-03-07 | 2026-04-08 |
| DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers Alectinib - Haematological Malignancy, Malignant Neoplasm | Phase 2 / Phase 3 | Recruiting | Cancer Research UK | 30 | 2023-12-18 | 2025-11-24 |
| A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. lorlatinib, crizotinib, brigatinib - Non-Small Cell Lung Cancer | Completed | Pfizer | 5279 | 2023-06-23 | 2025-03-30 | |
| DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol Alectinib, Atezolizumab, Entrectinib - Haematological Malignancy, Solid Tumour | Phase 2 / Phase 3 | Recruiting | Cancer Research UK | 825 | 2023-03-01 | 2026-07-01 |
| SMMART Adaptive Clinical Treatment (ACT) Trial Alectinib, Alpelisib, Anastrozole - Advanced Breast Carcinoma, Advanced Malignant Solid Neoplasm | Early Phase 1 | Withdrawn | OHSU Knight Cancer Institute | 2023-01-30 | 2024-01-23 | |
| 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) Alectinib, Entrectinib, Durvalumab - Non-Small Cell Lung Cancer | Phase 3 | Active not recruiting | Hoffmann-La Roche | 68 | 2022-11-01 | 2026-11-02 |
| KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II Alectinib, Atezolizumab, Erlotinib - Solid Tumor, Advanced Solid Tumor | Active not recruiting | Seoul National University Bundang Hospital | 1000 | 2022-09-28 | 2026-09-30 | |
| Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer Alectinib, Cetuximab, Crizotinib - Metastatic Colorectal Cancer | Phase 2 | Recruiting | Oslo University Hospital | 40 | 2022-09-27 | 2023-02-21 |
| Alectinib Pharmacokinetic in Patients With NSCLC Alectinib Oral Product - Non-small Cell Lung Cancer Stage IIIB, ALK Gene Mutation | Phase 1 / Phase 2 | Recruiting | Instituto Nacional de Cancerologia de Mexico | 45 | 2022-05-01 | 2026-04-08 |
| Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels Alectinib - Drug Monitoring, Carcinoma, Non-Small-Cell Lung | Phase 4 | Recruiting | University Medical Center Groningen | 196 | 2022-03-23 | 2024-05-13 |
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Carcinoma, Non-Small-Cell Lung (37) · Neoplasms (8) · Lung Neoplasms (7) · Brain Neoplasms (4) · Neoplasm Metastasis (4) · Breast Neoplasms (3) · Hematologic Neoplasms (3) · Lymphoma, Large-Cell, Anaplastic (3) · Neoplasms by Site (3) · Carcinoma, Renal Cell (2) · Colorectal Neoplasms (2) · Gastrointestinal Neoplasms (2) · Lymphoproliferative Disorders (2) · Neoplasms by Histologic Type (2) · Ovarian Neoplasms (2)
Hoffmann-La Roche (25) · Genentech, Inc. (4) · Fondazione Policlinico Universitario Agostino Gemelli IRCCS (3) · Pfizer (3) · Cancer Research UK (2) · China Medical University Hospital (2) · Hunan Province Tumor Hospital (2) · Instituto Nacional de Cancerologia de Mexico (2) · Massachusetts General Hospital (2) · Oslo University Hospital (2) · Takeda (2) · Aarhus University Hospital (1) · AstraZeneca (1) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (1) · Centre Leon Berard (1)
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Matthew Krebs, Dr (2) · Oscar G Arrieta Rodriguez, M.D., M.Sc. (2) · Yongchang Zhang, MD (2) · A.J. van der Wekken, PhD (1) · Aditi Bagchi, M.D., Ph.D. (1) · Andrea Botticelli (1) · Chang-Fang Chiu, Ph.D. (1) · Charles Swanton (1) · Diogo Gomes, MD (1) · E.E. Voest, prof. (1) · Egbert F. Smith, MD-PhD (1) · Enriqueta Felip, MD-PhD (1)
PMID 39661917, PMID 27863201, PMID 29748847, PMID 31706099, PMID 41213248, PMID 22327623, PMID 23814043, PMID 25153538, PMID 25349307, PMID 26708155, PMID 27130468, PMID 27544060, PMID 28447912, PMID 28501139, PMID 28586279, PMID 29320312, PMID 29656744, PMID 29668860, PMID 30052269, PMID 30215676, PMID 30857956, PMID 30981696, PMID 32009824, PMID 32027845, PMID 32418886, PMID 34083331, PMID 34339623, PMID 34389237, PMID 34423676, PMID 34808524, PMID 34876409, PMID 35086719, PMID 35275991, PMID 35568909, PMID 35598186, PMID 35649212, PMID 35995953, PMID 36814246, PMID 36870947, PMID 36969063, PMID 37424386, PMID 37574132, PMID 37793085, PMID 38190582, PMID 38598794, PMID 38630551, PMID 38724991, PMID 38898120, PMID 39096924, PMID 39521433
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