A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
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
2 other identifiers
interventional
296
23 countries
166
Brief Summary
A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2017
Longer than P75 for phase_3
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2017
CompletedFirst Posted
Study publicly available on registry
February 14, 2017
CompletedStudy Start
First participant enrolled
April 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedResults Posted
Study results publicly available
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
ExpectedNovember 25, 2025
November 1, 2025
2.9 years
January 20, 2017
March 5, 2021
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment
PFS was defined as the time from randomization to the date of the first documentation of progressive disease as assessed by the independent radiologist or death due to any cause, whichever occurred first. PFS (in months) was calculated as (date of event or censoring-randomization+1)/30.4375. Progressive disease is defined per RECIST version 1.1, as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.
From time of Study Start up to 33 months
Secondary Outcomes (27)
Overall Survival (OS)
From time of Study Start up to 33 months
Progression-Free Survival (PFS) Based on Investigator's Assessment
From time of Study Start up to 33 months
Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on BICR Assessment
From time of Study Start up to 33 months
Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on Investigator's Assessment
From time of Study Start up to 33 months
Intracranial Objective Response Rate (IC-ORR) - Percentage of Participants With Intracranial Objective Response (IC-OR) Based on BICR Assessment
From time of Study Start up to 33 months
- +22 more secondary outcomes
Study Arms (2)
Lorlatinib
EXPERIMENTALLorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously
Crizotinib
ACTIVE COMPARATORCrizotinib single agent, 250 mg (1 x 250) oral capsules, BID, continuously
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK-positive NSCLC; at least 1 extracranial measurable target lesion not previously irradiated. CNS metastases allowed if asymptomatic and not currently requiring corticosteroid treatment.
- Availability of an archival FFPE tissue specimen.
- No prior systemic NSCLC treatment.
- ECOG PS 0, 1, or 2.
- Age ≥18 years .
- Adequate Bone Marrow, Liver, Renal, Pancreatic Function
- Negative pregnancy test for females of childbearing potential
You may not qualify if:
- Spinal cord compression unless good pain control attained
- Major surgery within 4 weeks prior to randomization.
- Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation. Whole brain irradiation within 4 weeks prior to randomization
- Active bacterial, fungal, or viral infection
- Clinically significant cardiovascular disease, active or within 3 months prior to enrollment. Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation, bradycardia or congenital long QT syndrome
- Predisposing characteristics for acute pancreatitis in the last month prior to randomization.
- History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease
- Active malignancy (other than NSCLC, non melanoma skin cancer, in situ cervical cancer, papillary thyroid cancer, LCIS/DCIS of the breast, or localized prostate cancer) within the last 3 years prior to randomization.
- Concurrent use of any of the following food or drugs within 12 days prior to the first dose of lorlatinib or crizotinib.
- known strong CYP3A inhibitors .
- known strong CYP3A inducers
- known P gp substrates with a narrow therapeutic index
- Concurrent use of CYP3A substrates with narrow therapeutic indices within 12 days prior to the first dose of lorlatinib or crizotinib.
- Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results
- Investigational site staff members directly involved in the conduct of the study and their family members, or Pfizer employees, including their family members, directly involved in the conduct of the study.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (166)
Florida Cancer Specialists
Altamonte Springs, Florida, 32701, United States
Florida Cancer Specialists
Brandon, Florida, 33511, United States
Florida Cancer Specialists
Clearwater, Florida, 33761, United States
Florida Cancer Specialists
Gainesville, Florida, 32605, United States
Florida Cancer Specialists
Largo, Florida, 33770, United States
Florida Cancer Specialists
Lecanto, Florida, 34461, United States
Florida Cancer Specialists
Orange City, Florida, 32763, United States
Florida Cancer Specialists
Orlando, Florida, 32806, United States
Florida Cancer Specialists
Spring Hill, Florida, 34608, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists
Tampa, Florida, 33607, United States
Florida Cancer Specialists
Tavares, Florida, 32778, United States
Florida Cancer Specialists
The Villages, Florida, 32159, United States
Florida Cancer Specialists
Winter Park, Florida, 32792, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Ophthalmic Consultants of Boston Inc
Boston, Massachusetts, 02114, United States
The William P. Beetham Eye Institute, Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
University of Rochester Cancer Center Pharmacy
Rochester, New York, 14642, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Tennessee Oncology, PLLC
Dickson, Tennessee, 37055, United States
Tennessee Oncology, PLLC
Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, 37066, United States
Tennessee Oncology, PLLC
Hermitage, Tennessee, 37076, United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, 37090, United States
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, 37129, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
The Sarah Cannon Research Institute.
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37207, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37211, United States
Tennessee Oncology, PLLC
Shelbyville, Tennessee, 37160, United States
Tennessee Oncology, PLLC
Smyrna, Tennessee, 37167, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Centro de Investigacion Pergamino SA
Pergamino, Buenos Aires, B2700CPM, Argentina
Centro Medico Austral
CABA, C1019ABS, Argentina
Bendigo Day Surgery Collection Centre and Laboratory
Bendigo, Victoria, 3550, Australia
Bendigo Medical Imaging, Bendigo Hospital
Bendigo, Victoria, 3550, Australia
Melbourne Pathology
Bendigo, Victoria, 3550, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Grand Hopital de Charleroi - Site Notre Dame
Charleroi, 6000, Belgium
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
The Affiliated Hospital of Military Medical Sciences
Beijing, Beijing Municipality, 100071, China
Jilin Provincial Cancer Hospital
Changchun, Jilin, 130012, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Department of Respiratory,the First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Beijing Cancer Hospital
Beijing, 100142, China
Guangdong General Hospital
Guangzhou, 510000, China
Fakultni nemocnice Olomouc, Klinika plicnich nemoci a tuberkulozy
Olomouc, 779 00, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Hopital Haut-Léveque-Centre François Magendie
Pessac, Aquitaine, 33604, France
Hopital de Chevilly Larue
Chevilly-Larue, 94550, France
Centre Hospitalier du Mans
Le Mans, 72000, France
Institut Paoli-Calmettes
Marseille, 13273, France
Département d'Imagerie Médicale
Marseille, 13915, France
Hôpital Nord
Marseille, 13915, France
Service Ophtalmologie
Marseille, 13915, France
Groupe Hospitalier Bichat Claude Bernard, AP-HP
Paris, 75018, France
CHU de Rennes Hopital Pontchaillou
Rennes, 35033, France
CHU de Rennes, Hopital Pontchaillou
Rennes, 35033, France
Hopital Foch
Suresnes, 92150, France
Hopital Larrey
Toulouse, 31059, France
Hopital Pierre Paul Riquet
Toulouse, 31059, France
Hôpital Larrey
Toulouse, 31059, France
Department d'imagerie medicale
Villejuif, 94805, France
Institut Gustave Roussy
Villejuif, 94805, France
Uberortliche Radiologische Gemeinschaftspraxis Dr. med. Marc Amler
Dresden, 01309, Germany
Technische Universitat Dresden , Medizinische Fakultat Carl Gustav Carus
Dresden, D-01307, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, D-69126, Germany
Universitatsklinikum Heidelberg
Heidelberg, D-69126, Germany
Universitätsklinikum des Saarlandes, Innere Medizin V
Homburg - Saar, 66421, Germany
Universitätsklinikum des Saarlandes
Homburg - Saar, 66421, Germany
Universitatsklinikum Regensburg, Institut fur Rontgendiagnostik
Regensburg, 93053, Germany
Universitatsklinikum Regensburg, Klinik und Poliklinik fur Innere Medizin II
Regensburg, 93053, Germany
The University of Hong Kong, Department of Clinical Oncology
Hong Kong, Hong Kong
The University of Hong Kong, Department of Medicine
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Artemis Hospital
Gurugram, Haryana, 122001, India
Manipal Hospital
Bangalore, Karnataka, 560017, India
Srinivasam Cancer Care Multispeciality Hospitals India Pvt Ltd
Bangalore, Karnataka, 560072, India
Sahyadri Clinical Research and Development Centre
Pune, Maharashtra, 411004, India
Sahyadri Specialty Hospital
Pune, Maharashtra, 411004, India
AOU Policlinico Vittorio Emanuele-P.O.G. Rodolico
Catania, CT, 95123, Italy
ASST Monza - A.O. San Gerardo
Monza, MB, 20900, Italy
IRCCS Ospedale San Raffaele
Milan, MI, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, 20133, Italy
Istituto Europeo di Oncologia
Milan, MI, 20141, Italy
Istituto Clinico Humanitas
Rozzano, MI, 20089, Italy
Azienda Ospedaliera di Perugia - Ospedale S. M. Misericordia
Perugia, PG, 06132, Italy
Centro di Riferimento Oncologico-IRCCS
Pordenone, PN, 33081, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, 43126, Italy
Istituto Nazionale Tumori Regina Elena
Roma, RM, 00144, Italy
Az.Osp.San Camillo-Forlanini
Roma, RM, 00152, Italy
Azienda Ospedaliera Dei Colli Ospedale Monaldi
Napoli, 80131, Italy
Istituto Nazionale Tumori di Napoli
Napoli, 80131, Italy
Ausl della Romagna- Ravenna
Ravenna, 48121, Italy
Aichi cancer center central hospital
Nagoya, Aichi-ken, 464-8681, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 981-0914, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Kindai University Hospital
Sayama, Osaka, 589-8511, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital
Chuo-Ku, Tokyo, 104-0045, Japan
National Hospital Organization, Yamaguchi-Ube Medical Center
Ube, Yamaguchi, 755-0241, Japan
The Cancer Institute Hospital of JFCR
Kōtoku, 135-8550, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
Wakayama Medical University Department of Pulmonary Medicine and Oncology
Wakayama, 641-8509, Japan
Médicos Especialistas en Cancer S.C. / San Peregrino.
Aguascalientes, 20230, Mexico
Instituto Nacional de Cancerologia
Distrito Federal, 14080, Mexico
Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas
Distrito Federal, 14080, Mexico
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Med-Polonia Sp. z o.o.
Poznan, 60-693, Poland
Centrum Medyczne Dom Lekarski S.A.
Szczecin, 70-784, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
RBHI Kursk Regional Clinical Oncology Dispensary
Kislino, Kursk Oblast, 305 524, Russia
Budgetary Healthcare Institution Omsk Region "Clinical Oncological Dispensary"
Omsk, Omsk Oblast, 644013, Russia
LEC at SBIH "Saint-Petersburg Clinical Research Practical Center of specialized types of
Pesochniy Poselok, Sankt-Peterburg, 197758, Russia
Private Medical Institution "Euromedservice"
Pushkin, Sankt-Peterburg, 196603, Russia
RBHI Kursk Regional Clinical Oncology Dispensary
Kursk, 305 035, Russia
FSBI "N.N.Blokhin Medical Research Center of Oncology"
Moscow, 115478, Russia
National University Hospital
Singapore, 119074, Singapore
Raffles Hospital
Singapore, 188770, Singapore
The Catholic University of Korea, St. Vincents Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Division of Medical Oncology, Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Institut Catala d'Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Canary Islands, 35016, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Complejo Hospitalario De Navarra
Pamplona, Navarre, 31008, Spain
Hospital Teresa Herrera C.H.U.A.C.
A Coruña, 15006, Spain
Hospital De La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036, Spain
Hospital De La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Institut Catala d'Oncologia Girona
Girona, 17007, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario La Fe
Valencia, 46026, Spain
National Taiwan University Hospital
Taipei, Taiwan ROC, 10002, Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, 83301, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Cukurova University Medical Faculty
Adana, 01330, Turkey (Türkiye)
Istanbul University Oncology Institute
Istanbul, 34093, Turkey (Türkiye)
Marmara Univ Pendik Training and Research Hospital
Istanbul, 34899, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
The Ipswich Hospital NHS Trust
Ipswich, Suffolk, IP4 5PD, United Kingdom
Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital
Birmingham, WEST Midlands, B9 5SS, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Publications (11)
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.
PMID: 41124598DERIVEDWu 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.
PMID: 40024442DERIVEDSolomon 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.
PMID: 39360949DERIVEDSolomon 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.
PMID: 38819031DERIVEDSoo 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.
PMID: 37295609DERIVEDSolomon 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.
PMID: 36535300DERIVEDSolomon 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.
PMID: 35605188DERIVEDSolomon 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.
PMID: 34585621DERIVEDShaw 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.
PMID: 33207094DERIVEDShaw 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.
PMID: 29074098DERIVEDGainor 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.
PMID: 28501139DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 20, 2017
First Posted
February 14, 2017
Study Start
April 27, 2017
Primary Completion
March 20, 2020
Study Completion (Estimated)
December 31, 2028
Last Updated
November 25, 2025
Results First Posted
April 1, 2021
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.