NCT03052608

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Official title

A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF LORLATINIB (PF-06463922) MONOTHERAPY VERSUS CRIZOTINIB MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED ALK-POSITIVE NON-SMALL CELL LUNG CANCER

Phase

Phase 3

Status

Active not recruiting

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Lorlatinib; Crizotinib

Arms

• Lorlatinib · Experimental
• Crizotinib · Active comparator

Enrollment

296

Primary outcomes

• Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment

Sponsor

Pfizer

Start

Apr 27, 2017

Primary completion

Mar 20, 2020

Results posted

Yes

Registry record

NCT03052608 · updated Nov 25, 2025

• Lu SL, Chang YC, Liang CH, Chiang PL, Maresca K, Pollom E, Wilner K, Lu JT, Toffalorio F, Giaccone G, Duan C. Artificial intelligence-enabled early intracranial volumetric response predicts systemic progression-free survival in the phase III CROWN study. Neurooncol Adv. 2026 Sep 7;8(1):vdag236. doi: 10.1093/noajnl/vdag236. eCollection 2026 Jan-Dec. PubMed 42781551
• Liu G, Solomon BJ, Mazieres J, Kim DW, Cortinovis D, Inoue T, Sharma R, Thurm H, Polli A, Bauer TM. Kinetics and management of adverse events associated with lorlatinib after 5 years of follow-up in the CROWN study. Oncologist. 2025 Oct 1;30(10):oyaf287. doi: 10.1093/oncolo/oyaf287. PubMed 41124598
• Wu YL, Kim HR, Soo RA, Zhou Q, Akamatsu H, Chang GC, Chiu CH, Hayashi H, Kim SW, Goto Y, Kato T, Zhou J, Lee VH, Nishio M, Han B, Kim DW, Lu S, Polli A, Martini JF, Toffalorio F, Wong CH, Mok T. First-Line Lorlatinib Versus Crizotinib in Asian Patients With Advanced ALK-Positive NSCLC: Five-Year Outcomes From the CROWN Study. J Thorac Oncol. 2025 Jul;20(7):955-968. doi: 10.1016/j.jtho.2025.02.021. Epub 2025 Feb 28. PubMed 40024442
• Solomon BJ, Liu G, Felip E, K Mok TS, Soo RA, Mazieres J, Shaw AT, Marinis F, Goto Y, Wu YL, Kim DW, Martini JF, Messina R, Paolini J, Polli A, Thomaidou D, Toffalorio F, Bauer TM. Plain language summary: 5-year results from the CROWN study of lorlatinib vs crizotinib in non-small-cell lung cancer. Future Oncol. 2024 Dec;20(40):3377-3387. doi: 10.1080/14796694.2024.2406117. Epub 2024 Oct 3. PubMed 39360949
• Solomon BJ, Liu G, Felip E, Mok TSK, Soo RA, Mazieres J, Shaw AT, de Marinis F, Goto Y, Wu YL, Kim DW, Martini JF, Messina R, Paolini J, Polli A, Thomaidou D, Toffalorio F, Bauer TM. Lorlatinib Versus Crizotinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer: 5-Year Outcomes From the Phase III CROWN Study. J Clin Oncol. 2024 Oct 10;42(29):3400-3409. doi: 10.1200/JCO.24.00581. Epub 2024 May 31. PubMed 38819031
• Soo RA, Martini JF, van der Wekken AJ, Teraoka S, Ferrara R, Shaw AT, Shepard D, Calella AM, Polli A, Toffalorio F, Tomasini P, Chiu CH, Kowalski DM, Kim HR, Solomon BJ. Early Circulating Tumor DNA Dynamics and Efficacy of Lorlatinib in Patients With Treatment-Naive, Advanced, ALK-Positive NSCLC. J Thorac Oncol. 2023 Nov;18(11):1568-1580. doi: 10.1016/j.jtho.2023.05.021. Epub 2023 Jun 7. PubMed 37295609
• Solomon BJ, Bauer TM, Mok TSK, Liu G, Mazieres J, de Marinis F, Goto Y, Kim DW, Wu YL, Jassem J, Lopez FL, Soo RA, Shaw AT, Polli A, Messina R, Iadeluca L, Toffalorio F, Felip E. Efficacy and safety of first-line lorlatinib versus crizotinib in patients with advanced, ALK-positive non-small-cell lung cancer: updated analysis of data from the phase 3, randomised, open-label CROWN study. Lancet Respir Med. 2023 Apr;11(4):354-366. doi: 10.1016/S2213-2600(22)00437-4. Epub 2022 Dec 16. PubMed 36535300
• Solomon BJ, Bauer TM, Ignatius Ou SH, Liu G, Hayashi H, Bearz A, Penkov K, Wu YL, Arrieta O, Jassem J, Calella AM, Peltz G, Polli A, Thurm H, Mok T. Post Hoc Analysis of Lorlatinib Intracranial Efficacy and Safety in Patients With ALK-Positive Advanced Non-Small-Cell Lung Cancer From the Phase III CROWN Study. J Clin Oncol. 2022 Nov 1;40(31):3593-3602. doi: 10.1200/JCO.21.02278. Epub 2022 May 23. PubMed 35605188
• Solomon BJ, Bauer TM, de Marinis F, Felip E, Goto Y, Liu G, Mazieres J, Kim DW, Mok T, Polli A, Thurm H, Calella AM, Peltz G, Shaw AT. Plain language summary of the CROWN study comparing lorlatinib with crizotinib for people with untreated non-small cell lung cancer. Future Oncol. 2021 Dec 1;17(34):4649-4656. doi: 10.2217/fon-2021-0904. Epub 2021 Sep 29. PubMed 34585621
• Shaw AT, Bauer TM, de Marinis F, Felip E, Goto Y, Liu G, Mazieres J, Kim DW, Mok T, Polli A, Thurm H, Calella AM, Peltz G, Solomon BJ; CROWN Trial Investigators. First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer. N Engl J Med. 2020 Nov 19;383(21):2018-2029. doi: 10.1056/NEJMoa2027187. PubMed 33207094
• 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
• Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10. No abstract available. PubMed 28501139