21 completed, 12 recruiting, 10 active not recruiting, 7 terminated. 26 Phase 2, 18 Phase 1, 5 Phase 4, 3 Phase 3, 1 Early Phase 1.
Follow lorlatinib: new trials by email Literature Review of lorlatinib trials Research Report on lorlatinib
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 |
|---|---|---|---|---|---|---|
| Lorlatinib Plus Sacituzumab Tirumotecan With Peripheral ctDNA Guidance as First-Line Therapy for ALK Fusion-Positive NSCLC Lorlatinib, sacituzumab tirumotecan plus lorlatinib - ALK Positive Non-small Cell Lung Cancer | Phase 2 | Not yet recruiting | Guangdong Association of Clinical Trials | 153 | 2026-09-01 | 2026-08-06 |
| Study of NXP900 With Lorlatinib in ALK+ Lung Cancer NXP900, Lorlatinib - ALK Positive, ALK Positive Non-small Cell Lung Cancer | Phase 1 | Recruiting | Nuvectis Pharma, Inc. | 54 | 2026-08-17 | 2026-08-25 |
| AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer AQUA07, Lorlatinib - ALK Positive Non-small Cell Lung Cancer | Phase 1 | Recruiting | Chugai Pharmaceutical | 102 | 2026-07-24 | 2026-09-18 |
| A Study to Learn About Study Medicine Lorlatinib, as a First-line Treatment in Chinese Adults With ALK-positive a/mNSCLC Lorlatinib - Non-Small Cell Lung Cancer ALK-positive | Active not recruiting | Pfizer | 50 | 2026-05-18 | 2026-08-10 | |
| A Study to Learn About Patients With Non-Small Cell Lung Cancer (NSCLC) Who Took Lorlatinib as Their First Treatment lorlatinib - Non-Small-Cell Lung, ALK-positive Advanced NSCLC | Active not recruiting | Pfizer | 200 | 2026-05-01 | 2026-09-17 | |
| Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer Lorlatinib - Advanced Non-Small Cell Lung Cancer | Phase 2 | Recruiting | M.D. Anderson Cancer Center | 30 | 2026-04-24 | 2026-10-13 |
| Lorlatinib in ROS1+ NSCLC With Brain Metastasis Lorlatinib 100 mg - Lung Cancer (NSCLC) | Phase 2 | Not yet recruiting | Hunan Cancer Hospital | 21 | 2025-08-15 | 2025-07-24 |
| Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion Lorlatinib, Lorlatinib with chemotherapy1, Lorlatinib with chemotherapy 2 - High Grade Glioma, Diffuse Intrinsic Pontine Glioma | Early Phase 1 | Recruiting | Nationwide Children's Hospital | 15 | 2025-08-03 | 2026-06-29 |
| A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer (NSCLC) Which Has Spread Out. Lorlatinib - Carcinoma, Non-Small-Cell Lung | Completed | Pfizer | 22 | 2025-07-04 | 2026-07-10 | |
| 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 lorlatinib, lorlatinib plus chemotherapy - NSCLC | Phase 4 | Not yet recruiting | The First Affiliated Hospital of Guangzhou Medical University | 20 | 2025-05-10 | 2025-03-25 |
| Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma lorlatinib, concurrent/sequential platinum-based chemoradiotherapy - Neoadjuvant Non-Small Cell Lung Cancer | Phase 3 | Not yet recruiting | Guangdong Association of Clinical Trials | 36 | 2025-03-01 | 2025-03-05 |
| Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context Lorlatinib - ALK+ Non-Small-Cell Lung Carcinoma | Not applicable | Recruiting | Pfizer | 90 | 2025-01-20 | 2026-10-23 |
| Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer Lorlatinib 100 mg - Neoadjuvant Non-Small Cell Lung Cancer | Phase 2 | Not yet recruiting | Peking University People's Hospital | 25 | 2024-11-15 | 2024-11-12 |
| Real-world Study of Local Therapy Changes During 1L Lorlatinib in Unresectable ALK+ NSCLC Lorlatinib 100 mg - Lung Cancer, Non-Small Cell | Not yet recruiting | Peking University Cancer Hospital & Institute | 100 | 2024-11-10 | 2024-11-15 | |
| LORLATINIB-related HYPERLIPIDEMIA in ALK+ Non-Small Cell Lung Cancer Lorlatinib - Non-Small Cell Lung Cancer, Hyperlipidemia | Enrolling by invitation | Peking University Third Hospital | 167 | 2024-10-15 | 2025-03-14 | |
| 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 | |
| Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases Lorlatinib - Carcinoma, Non-Small-Cell Lung, Brain Metastases | Phase 4 | Active not recruiting | Guangdong Association of Clinical Trials | 41 | 2024-08-01 | 2026-04-09 |
| Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients Lorlatinib - ALK-positive Non-small Cell Lung Cancer, Real World Study | Recruiting | Sichuan Cancer Hospital and Research Institute | 200 | 2024-05-01 | 2024-04-12 | |
| A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib Lorlatinib - Non Small Cell Lung Cancer Metastatic, ALK Gene Mutation | Phase 2 | Recruiting | Centro di Riferimento Oncologico - Aviano | 45 | 2024-03-15 | 2024-04-23 |
| Lorlatinib in Combination With Chemotherapy in Participants With Metastatic Anaplastic Lymphoma Kinase Positive (ALK+) Non-small Cell Lung Cancer (NSCLC) Who Progressed on Single-agent Lorlatinib Lorlatinib, Cisplatin or Carboplatin, Pemetrexed - Lung Cancer, Non-small Cell Lung Cancer | Phase 2 | Withdrawn | SCRI Development Innovations, LLC | 2023-11-01 | 2023-12-13 |
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Carcinoma, Non-Small-Cell Lung (28) · Lung Neoplasms (7) · Neoplasm Metastasis (4) · Neoplasms (3) · Neuroblastoma (3) · Recurrence (3) · Brain Neoplasms (2) · Meningeal Carcinomatosis (2) · Adenocarcinoma of Lung (1) · Anemia (1) · Astrocytoma (1) · Blast Crisis (1) · Breast Neoplasms (1) · Carcinoma (1) · Colorectal Neoplasms (1)
Pfizer (26) · Guangdong Association of Clinical Trials (4) · Fondazione Policlinico Universitario Agostino Gemelli IRCCS (2) · Hunan Province Tumor Hospital (2) · Intergroupe Francophone de Cancerologie Thoracique (2) · Massachusetts General Hospital (2) · Sichuan Cancer Hospital and Research Institute (2) · CStone Pharmaceuticals (1) · Centro di Riferimento Oncologico - Aviano (1) · Children's Oncology Group (1) · Chugai Pharmaceutical (1) · European Organisation for Research and Treatment of Cancer - EORTC (1) · Fondazione Ricerca Traslazionale (1) · Fundación GECP (1) · Guangdong Provincial People's Hospital (1)
United States (29) · China (14) · France (8) · Italy (8) · Spain (7) · Belgium (6) · Australia (5) · Canada (5) · Japan (5) · South Korea (5) · Taiwan (5) · India (4) · Netherlands (4) · United Kingdom (4) · Germany (3)
Denis Moro-Sibilot (2) · Ibiayi Dagogo-Jack, MD (2) · Michael Duruisseaux (2) · Yi-Long Wu, MD (2) · Yongchang Zhang, MD (2) · Anne-Marie Dingemans, MD (1) · Antonio Calles, MD (1) · Christine Lovly, MD, PhD (1) · E E Ke, M.D. (1) · E.E. Voest, prof. (1) · Fan F Yang, M.D. (1) · Gregory Riely, MD, PhD (1)
PMID 29074098, PMID 26698910, PMID 28501139, PMID 30413378, PMID 31669155, PMID 31728714, PMID 31863284, PMID 32060867, PMID 32344248, PMID 33207094, PMID 33937953, PMID 33937954, PMID 33973232, PMID 34028986, PMID 34486544, PMID 34585621, PMID 34623637, PMID 35018553, PMID 35026476, PMID 35086719, PMID 35584349, PMID 35598186, PMID 35605188, PMID 35660971, PMID 36184067, PMID 36535300, PMID 36870947, PMID 37012551, PMID 37295609, PMID 37424386, PMID 38079095, PMID 38344203, PMID 38630551, PMID 38819031, PMID 38879393, PMID 39034968, PMID 39360949, PMID 39581380, PMID 39863139, PMID 40024442, PMID 40541556, PMID 41124598, PMID 41296331, PMID 41949116, PMID 41986720, PMID 42749050, PMID 42781551, PMID 42872552
2019 (3), 2015 (2), 2023 (2), 2016 (1), U10CA180868 (1), U10CA180886 (1)