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Clinical trial · no report yet · Phase 1/Phase 2

NCT01970865

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

We haven't built an HCP commentary report on NCT01970865 yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Indexed commentary on NCT01970865 so far

Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.

ChannelIndexed
X threads3

The trial

ClinicalTrials.gov
Official title
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
Phase
Phase 1/Phase 2
Status
Completed
Conditions
ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC
Interventions
PF-06463922; Crizotinib
Arms
  • PF-06463922 · Experimental
  • Crizotinib · Other
Enrollment
364
Primary outcomes
  • Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1
  • Percentage of Participants With Overall and Intracranial Objective Response (Phase 2)
Sponsor
Pfizer
Start
Jan 8, 2014
Primary completion
Mar 15, 2017
Results posted
Yes
Registry record
NCT01970865 · updated Aug 12, 2024

Publications

linked from the registry
  • Bauer TM, Martini JF, Besse B, Lin CC, Soo RA, Riely GJ, Wang IM, Toffalorio F, Shepard DA, Usari T, Hamilton P, Camidge DR, Kao S, Chiari R, Gadgeel S, Felip E, Shaw AT, Solomon BJ. Final Biomarker and Efficacy Analyses of Lorlatinib in Patients With ALK-Positive Advanced NSCLC in a Phase 2 Study. J Thorac Oncol. 2026 Sep 17:104202. doi: 10.1016/j.jtho.2026.104202. Online ahead of print. PubMed 42749050
  • Ou SI, Solomon BJ, Besse B, Bearz A, Lin CC, Chiari R, Camidge DR, Lin JJ, Abbattista A, Toffalorio F, Soo RA. Final Overall Survival and Long-Term Safety of Lorlatinib in Patients With ALK-Positive NSCLC From the Pivotal Phase 2 Study: A Brief Report. J Thorac Oncol. 2025 Apr;20(4):513-520. doi: 10.1016/j.jtho.2024.11.021. Epub 2024 Nov 22. PubMed 39581380
  • Chen J, Bearz A, Kim DW, Mamdani H, Bauman J, Chiari R, Ou SI, Solomon BJ, Soo RA, Felip E, Shaw AT, Thurm H, Clancy JS, Lee K, O'Gorman M, Tanski C, Pithavala YK. Evaluation of the Effect of Lorlatinib on CYP2B6, CYP2C9, UGT, and P-Glycoprotein Substrates in Patients with Advanced Non-Small Cell Lung Cancer. Clin Pharmacokinet. 2024 Feb;63(2):171-182. doi: 10.1007/s40262-023-01309-4. Epub 2023 Dec 11. PubMed 38079095
  • Dagogo-Jack I, Abbattista A, Murphy JF, Krulewicz S, Do A, Peterson J, Lin JJ, Gainor JF, Messina R, Krueger EA, Thurm H, Yeap BY. Factors Associated With Developing Neurocognitive Adverse Events in Patients Receiving Lorlatinib After Progression on Other Targeted Therapies. J Thorac Oncol. 2023 Jan;18(1):67-78. doi: 10.1016/j.jtho.2022.09.219. Epub 2022 Sep 29. PubMed 36184067
  • Soo RA, Huat Tan E, Hayashi H, Seto T, Lin CC, Ou SI, Kim DW, Liu G, Abbattista A, Martini JF, Hooi Wong C, Toffalorio F, Solomon BJ. Efficacy and safety of lorlatinib in Asian and non-Asian patients with ALK-positive advanced non-small cell lung cancer: Subgroup analysis of a global phase 2 trial. Lung Cancer. 2022 Jul;169:67-76. doi: 10.1016/j.lungcan.2022.05.012. Epub 2022 May 23. PubMed 35660971
  • Ou SI, Solomon BJ, Shaw AT, Gadgeel SM, Besse B, Soo RA, Abbattista A, Toffalorio F, Wiltshire R, Bearz A. Continuation of Lorlatinib in ALK-Positive NSCLC Beyond Progressive Disease. J Thorac Oncol. 2022 Apr;17(4):568-577. doi: 10.1016/j.jtho.2021.12.011. Epub 2022 Jan 10. PubMed 35026476
  • Chen J, Ruiz-Garcia A, James LP, Peltz G, Thurm H, Clancy J, Hibma J. Lorlatinib Exposure-Response Analyses for Safety and Efficacy in a Phase I/II Trial to Support Benefit-Risk Assessment in Non-Small Cell Lung Cancer. Clin Pharmacol Ther. 2021 Nov;110(5):1273-1281. doi: 10.1002/cpt.2228. Epub 2021 Jun 26. PubMed 33973232
  • Chen J, O'Gorman MT, James LP, Klamerus KJ, Mugundu G, Pithavala YK. Pharmacokinetics of Lorlatinib After Single and Multiple Dosing in Patients with Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer: Results from a Global Phase I/II Study. Clin Pharmacokinet. 2021 Oct;60(10):1313-1324. doi: 10.1007/s40262-021-01015-z. Epub 2021 May 3. PubMed 33937954
  • Peters S, Shaw AT, Besse B, Felip E, Solomon BJ, Soo RA, Bearz A, Gadgeel SM, Lin CC, Kao S, Seto T, Masters ET, Abbattista A, Clancy JS, Thurm H, Reisman A, Peltz G, Ross Camidge D. Impact of lorlatinib on patient-reported outcomes in patients with advanced ALK-positive or ROS1-positive non-small cell lung cancer. Lung Cancer. 2020 Jun;144:10-19. doi: 10.1016/j.lungcan.2020.02.011. Epub 2020 Mar 10. PubMed 32344248
  • Bauer TM, Shaw AT, Johnson ML, Navarro A, Gainor JF, Thurm H, Pithavala YK, Abbattista A, Peltz G, Felip E. Brain Penetration of Lorlatinib: Cumulative Incidences of CNS and Non-CNS Progression with Lorlatinib in Patients with Previously Treated ALK-Positive Non-Small-Cell Lung Cancer. Target Oncol. 2020 Feb;15(1):55-65. doi: 10.1007/s11523-020-00702-4. PubMed 32060867
  • Shaw AT, Solomon BJ, Chiari R, Riely GJ, Besse B, Soo RA, Kao S, Lin CC, Bauer TM, Clancy JS, Thurm H, Martini JF, Peltz G, Abbattista A, Li S, Ou SI. Lorlatinib in advanced ROS1-positive non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2019 Dec;20(12):1691-1701. doi: 10.1016/S1470-2045(19)30655-2. Epub 2019 Oct 25. PubMed 31669155
  • Solomon BJ, Besse B, Bauer TM, Felip E, Soo RA, Camidge DR, Chiari R, Bearz A, Lin CC, Gadgeel SM, Riely GJ, Tan EH, Seto T, James LP, Clancy JS, Abbattista A, Martini JF, Chen J, Peltz G, Thurm H, Ou SI, Shaw AT. Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol. 2018 Dec;19(12):1654-1667. doi: 10.1016/S1470-2045(18)30649-1. Epub 2018 Nov 6. PubMed 30413378
  • Shaw AT, Felip E, Bauer TM, Besse B, Navarro A, Postel-Vinay S, Gainor JF, Johnson M, Dietrich J, James LP, Clancy JS, Chen J, Martini JF, Abbattista A, Solomon BJ. Lorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol. 2017 Dec;18(12):1590-1599. doi: 10.1016/S1470-2045(17)30680-0. Epub 2017 Oct 23. PubMed 29074098
  • Shaw AT, Friboulet L, Leshchiner I, Gainor JF, Bergqvist S, Brooun A, Burke BJ, Deng YL, Liu W, Dardaei L, Frias RL, Schultz KR, Logan J, James LP, Smeal T, Timofeevski S, Katayama R, Iafrate AJ, Le L, McTigue M, Getz G, Johnson TW, Engelman JA. Resensitization to Crizotinib by the Lorlatinib ALK Resistance Mutation L1198F. N Engl J Med. 2016 Jan 7;374(1):54-61. doi: 10.1056/NEJMoa1508887. Epub 2015 Dec 23. PubMed 26698910
Analysis of public HCP commentary. Not medical advice and not for promotional use. Reports do not judge efficacy, estimate consensus or promote any product.
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