Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2025
Final Overall Survival and Long-Term Safety of Lorlatinib in Patients With ALK-Positive NSCLC From the Pivotal Phase 2 Study: A Brief Report.
Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01970865 (PHASE 1/2 STUDY OF PF-06463922), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 1/2 study of pf-06463922 (an alk/ros1 tyrosine kinase inhibitor) in patients with advanced non-small cell lung cancer harboring specific molecular alterations
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparison of the efficacy based on clinicopathological characteristics and the safety of first-line treatments for patients with advanced ALK rearrangement non-small cell lung cancer: a network meta-analysis.Frontiers in oncology · 2025Pooled it
- Lorlatinib in patients withFuture oncology (London, England) · 2026Trial
- Efficacy and safety of second-line treatments in ALK mutation-positive advanced non-small cell lung cancer after second- or third-generation ALK inhibitors: Turkish Oncology Group real-life study (TOG study).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Refining first-line therapy in ALK-positive non-small cell lung cancer: final overall survival from the ALEX trial and an evolving treatment landscape.Journal of thoracic disease · 2026Article
- Case report: first-line lorlatinib in metastatic lung adenocarcinoma with a novel WIPF1-ALK and EML4-ALK dual fusion.Translational lung cancer research · 2026Article
- ALK-tyrosine kinase inhibitor resistance due to acquiredTranslational lung cancer research · 2026Article
- Role of solute carrier transporters in the biodistribution and toxicity of chemotherapeutic drugs.Pharmacological reviews · 2026Review
- Targeted Therapy-Induced Interstitial Lung Disease in NSCLC: Mechanisms, Clinical Signatures, and a Precision Medicine Roadmap.Drug design, development and therapy · 2026Review
- Lorlatinib in advanced ALK-positive NSCLC after prior progression on ALK inhibitors: real-world experience in Russia.Exploration of targeted anti-tumor therapy · 2026Article
- Review
- Early Weight Gain as a Risk Factor for Increased Maximum Weight Gain Among Patients With NSCLC on Lorlatinib and Other ALK Tyrosine Kinase Inhibitors.JTO clinical and research reports · 2025Article
- Long-term survival outcomes of lorlatinib in advanced anaplastic lymphoma kinase (ALK)-fusion positive non-small cell lung cancer.Translational lung cancer research · 2025Article
- Precision-medicine management recommendations for advanced non-small cell lung cancer: expert consensus.Future oncology (London, England) · 2025Article
- Navigating treatment sequencing in ALK-positive non-small cell lung cancer: lorlatinib as a key to prolonged survival?Translational lung cancer research · 2025Article
- Lorlatinib in ALK-positive non-small cell lung cancer: final survival data that reshape the therapeutic landscape.Translational lung cancer research · 2025Article
- Long-term efficacy and improved overall survival of lorlatinib in anaplastic lymphoma kinase-rearranged lung cancer: is cure a dream or a reality?Translational lung cancer research · 2025Article
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionLorlatinib is a potent, brain-penetrant, third-generation inhibitor of anaplastic lymphoma kinase (ALK) and ROS1 tyrosine kinases with broad coverage of ALK resistance mutations. We present the overall survival (OS) and long-term safety of lorlatinib in patients with advanced ALK-positive NSCLC from the final analyses of the pivotal phase 2 study.
methodsAdults with ALK-positive NSCLC, enrolled in expansion cohorts (EXPs) on the basis of prior therapy (EXP1-5), received lorlatinib 100 mg orally once daily in continuous 21-day cycles. The primary endpoint was the objective response rate; secondary endpoints included OS and safety.
resultsThirty patients were enrolled in EXP1 (treatment naïve), 59 in EXP2-3A (disease progression after crizotinib ± chemotherapy), 28 in EXP3B (disease progression after one second-generation ALK tyrosine kinase inhibitor [TKI] ± chemotherapy), 111 in EXP4-5 (disease progression after ≥2 ALK TKIs ± chemotherapy), and 139 in EXP3B-5 (disease progression after ≥1 ALK TKI ± chemotherapy). Median OS was not reached (NR) (95% confidence interval [CI]: NR-NR) in EXP1, NR (95% CI: 51.5-NR) in EXP2-3A, 37.4 months (95% CI: 12.3-NR) in EXP3B, 19.2 months (95% CI: 15.4-30.2) in EXP4-5, and 20.7 months (95% CI: 16.1-30.3) in EXP3B-5. All-cause adverse events leading to dose reduction were reported in 77 patients (28%), temporary treatment discontinuation in 158 patients (57%), and permanent discontinuation in 35 patients (13%).
conclusionsAfter a minimum follow-up of five years, final analyses from the global phase 2 study confirmed substantial activity, prolonged OS, and generally consistent safety findings with lorlatinib in treatment-naïve and previously treated patients with ALK-positive NSCLC. CLINICALTRIALS: gov NCT01970865.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.