An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Phase 3, Randomized, Open-Label Study Of The Efficacy And Safety Of PF-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932893
• Other study ID #: A8081007
• Secondary ID: 2009-012595-27
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2009
• Last updated: February 4, 2016
• Start date: September 2009
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: January 2016
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically or cytologically proven diagnosis of non-small cell lung cancer

• positive for the ALK fusion gene (test provided by a central laboratory)

• must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug

• tumors must be measurable

Exclusion Criteria:

• prior treatment with PF-02341066

• current treatment in another clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• PF-02341066
PF-02341066, 250 mg BID will be administered orally on a continuous schedule
• Pemetrexed
Pemetrexed, 500 mg/m^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle
• Docetaxel
Docetaxel, 75 mg/m^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital, Department of Medical Oncology	Adelaide	South Australia
Australia	Sydney Cancer Centre	Camperdown	New South Wales
Australia	Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology	East Melbourne	Victoria
Australia	Department of Medical Oncology	Nedlands	Western Australia
Brazil	Fundacao Pio XII Hospital de Cancer de Barretos	Barretos	SP
Brazil	Associacao Hospital de Caridade de Ijui	Ijui	RS
Brazil	Fundacao Hospital Amaral Carvalho	Jau	Sao Paulo
Brazil	Hospital Sao Lucas da PUCRS	Porto Alegre	RS
Brazil	Irmandade da Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RS
Brazil	Instituto Nacional de Câncer - INCA	Rio de Janeiro	RJ
Brazil	Nucleo de Oncologia da Bahia	Salvador	BA
Brazil	Fundacao Antonio Prudente	Sao Paulo	SP
Brazil	Instituto do Câncer de São Paulo "Octavio Frias de Oliveira" - ICESP	Sao Paulo	SP
Bulgaria	MDOZS Plovdiv EOOD; Parvo vatreshno himioterapevtichno otdelenie	Plovdiv
Bulgaria	MBAL Voennomeditsinska Academia, MMA HAT Sofia	Sofia
Bulgaria	Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya	Sofia
Bulgaria	UMBAL "Tsaritsa Yoanna - ISUL", Klinika po onkoterapiya	Sofia
Bulgaria	MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi	Varna
Canada	Alberta Health Services, Holy Cross Site	Calgary	Alberta
Canada	Office of Dr. John McWhae	Calgary	Alberta
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Dr. Georges-L. Dumont Regional Hospital	Moncton	New Brunswick
Canada	Dr. Leon Richard Oncology Centre	Moncton	New Brunswick
Canada	Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM)	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	St. Mary's Hospital Center	Montreal	Quebec
Canada	Dr. Dana Blakolmer and Associates	Oshawa	Ontario
Canada	RSM Durham Regional Cancer Centre	Oshawa	Ontario
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario
China	307 Hospital of PLA	Beijing
China	Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC	Beijing
China	Guangdong General Hospital	Guangzhou	Guangdong
China	SUN Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Nanjing Bayi Hospital	Nanjing	Jiangsu
China	Shanghai Chest Hospital	Shanghai
China	Shanghai Chest Hospital/Department of Pulmonary Medicine	Shanghai
China	Shanghai Pulmonary Hospital/Dept. of Oncology	Shanghai
China	Zhongshan Hospital Fudan University / Respiratory Department	Shanghai
France	Centre Francois Baclesse	Caen Cedex 05
France	Centre Georges-François Leclerc	Dijon
France	Hopital Albert Michallon	Grenoble Cedex 09
France	Pr Fabrice BARLESI	Marseille Cedex 20
France	Centre Antoine Lacassagne	NICE Cedex 2
France	Groupe Hospitalier Cochin	Paris Cedex 14
France	Hopital Tenon / Service de Pneumologie	Paris cedex 20
France	Centre Rene Gauducheau / Service d'Oncologie Medicale	St Herblain Cedex
France	Institut Gustave Roussy	Villejuif
Germany	Universitaetsklinik Carl-Gustav-Carus Dresden	Dresden
Germany	Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung	Essen
Germany	Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie	Grosshansdorf
Germany	MVZ Prof. Mathey, Pfrof. Schofer GmbH	Hamburg
Germany	Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren	Heidelberg
Germany	St. Vincentius-Kliniken Karlsruhe	Karlsruhe
Germany	Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin	Koeln
Germany	Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie	Muenchen
Germany	Pius-Hospital Oldenburg	Oldenburg
Germany	HSK Dr.- Horst-Schmidt-Kliniken GmbH, Haematologie/Onkologie, Innere Medizin III	Wiesbaden
Greece	General Hospital of Chest Diseases of Athens "Sotiria"	Athens
Greece	General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department	Exohi	Thessaloniki
Greece	University General Hospital of Heraklion/ Department of Clinical Oncology	Heraklion	Crete
Hong Kong	Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital	Pokfulam
Hong Kong	Department of Clinical Oncology, Prince of Wales Hospital	Shatin, New Territories
Hong Kong	Tuen Mun Hospital, Department of Clinical Oncology	Tuen Mun	New Territories
Hungary	Orszagos Koranyi TBC és Pulmonologiai Intezet, VI. Bronchologia	Budapest
Hungary	Semmelweis Egyetem Pulmonologia Intezet	Budapest
Hungary	Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Tudogyogyaszati Klinika	Debrecen
Hungary	Veszprem Megyei Onkormanyzat Tudogyogyintezete	Farkasgyepu
Hungary	Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly	Szekesfehervar
Hungary	Pest Megyei Tudogyogyintezet, III. Osztaly	Torokbalint
Ireland	Aseptic Compounding Unit	Dublin 8
Ireland	Department of Medical Oncology	Dublin 8
Ireland	Department of Medical Oncology	Galway
Italy	Divisione di Oncologia Medica, Ospedale San Giuseppe Moscati, Citta' Ospedaliera	Avellino
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	Oncologia Medica A	Genova
Italy	Ospedale Versilia, Oncologia Medica	Lido di Camaiore (LU)
Italy	Ospedale San Luca	Lucca
Italy	Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative	Milano
Italy	Istituto Europeo di Oncologia	Milano
Italy	Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk	Milano
Italy	Nuovo Ospedale San Gerardo	Monza
Italy	Azienda Ospedaliera Universitaria San Luigi Gonzaga	Orbassano (TO)
Italy	SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia	Perugia
Italy	Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani	Roma
Italy	Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette	Torino
Japan	Hyogo Cancer Center	Akashi	Hyogo
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	National Kyushu Cancer Center	Fukuoka
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Aichi cancer center central hospital	Nagoya	Aichi
Japan	Okayama University Hospital / Department of Respiratory Medicine and Allergy	Okayama-city	Okayama
Japan	Kinki University Hospital	Osakasayama-shi	Osaka
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Korea, Republic of	National Cancer Center, Center for Lung Cancer	Goyang-si	Gyeonggi-do
Korea, Republic of	Samsung MedicaCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine	Seoul
Korea, Republic of	Seoul National University Hospital / Department of Internal Medicine	Seoul
Netherlands	Universitair Medisch Centrum Groningen / Afdeling Inwendige Geneeskunde	Groningen
Poland	Klinika Onkologii i Radioterapii	Gdansk
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc	Olsztyn
Poland	Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy	Otwock
Poland	Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii	Poznan
Russian Federation	Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic	Kazan
Russian Federation	State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS"	Moscow
Russian Federation	Research Institute of Pulmonology	Saint-Peterburg
Russian Federation	Saint-Petersburg State Medical University	Saint-Petersburg
Russian Federation	State Medical Institution "Oncology Center #2" of Healthcare Department of Krasnodar Region	Sochi
Russian Federation	City Clinical Oncology Dispensary	St. Petersburg
Spain	Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera (Materno-Infantil)	A Coruña
Spain	Hospital Universitari Germans Trias I Pujol	Badalona	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Hospital General Universitari Vall D´Hebron	Barcelona
Spain	Institut Catala Doncologia - Hospital Duran I Reynals	L'hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital de Navarra	Pamplona	Navarra
Spain	Consorcio Hospitalario Parc Tauli	Sabadell	Barcelona
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Sweden	Karolinska Universitetssjukhuset, Onkologiska kliniken	Stockholm
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital, Department of Internal Medicine	Taipei
Taiwan	Taipei Veterans General Hospital, Chest Department	Taipei
United Kingdom	Nuffield Health Wessex Hospital	Eastleigh
United Kingdom	Department of Oncology	London
United Kingdom	Kings College London at Guy's Hospital	London
United Kingdom	Royal Marsden Hospital	London
United Kingdom	Christie Hospital NHS Trust, Department of Medical Oncology	Manchester
United Kingdom	Cancer and Haematology Centre,	Oxford
United Kingdom	Southampton University Hospitals NHS Trust	Southampton
United Kingdom	Royal Marsden Hospital	Sutton	Surrey
United States	Emory Clinic	Atlanta	Georgia
United States	Emory University Clinic	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Georgia Cancer Specialists-Administrative Annex	Atlanta	Georgia
United States	Winship Cancer Institution	Atlanta	Georgia
United States	Drug Shipment: University of Colorado Cancer Center, Anschutz Cancer Pavilion	Aurora	Colorado
United States	University of Colorado Denver (CTRC)	Aurora	Colorado
United States	Unviersity of Colorado Hospital, Anschutz Cancer Pavilion	Aurora	Colorado
United States	Unviersity of Colorado Hospital, Anschutz Inpatient Pavilion	Aurora	Colorado
United States	Comprehensive Blood and Cancer Center	Bakersfield	California
United States	Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	Tower Cancer Research Foundation	Beverly Hills	California
United States	Tower Hematology Oncology Medical Group	Beverly Hills	California
United States	Beth Isreal Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	DFCI/Pharmacy (Drug Shipment Only)	Boston	Massachusetts
United States	Massachusette General Hospital	Boston	Massachusetts
United States	Massachussetts General Hospital	Boston	Massachusetts
United States	UNC Health Care, NC Cancer Hospital Infusion/lnpatient Pharmacy (CHIP)	Chapel Hill	North Carolina
United States	UNC Hospitals	Chapel Hill	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	James Care in Kenny	Columbus	Ohio
United States	The Ohio State University Hospital East	Columbus	Ohio
United States	The Ohio State University James Cancer Hospital and Solove Research Institute	Columbus	Ohio
United States	Siteman Cancer Center- West County	Creve Coeur	Missouri
United States	Georgia Cancer Specialists - Stemmer	Decatur	Georgia
United States	Kaiser Permanente	Denver	Colorado
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Tennessee Oncology, PLLC	Dickson	Tennessee
United States	Pharma Resource	East Providence	Rhode Island
United States	Vincent Armenio, MD	East Providence	Rhode Island
United States	Lawrence and Idell Weisberg Cancer Treatment Center	Farmington Hills	Michigan
United States	Tennessee Oncology, PLLC	Franklin	Tennessee
United States	Tennessee Oncology, PLLC	Gallatin	Tennessee
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Ingalls Memorial Hospital (Drug Shipment Only)	Harvey	Illinois
United States	Monroe Medical Associates	Harvey	Illinois
United States	Tennessee Oncology, PLLC	Hermitage	Tennessee
United States	Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute	Hershey	Pennsylvania
United States	Memorial Cancer Institute	Hollywood	Florida
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Hawaii Medical Center East	Honolulu	Hawaii
United States	OnCare Hawaii, Inc.	Honolulu	Hawaii
United States	The University of Texas	Houston	Texas
United States	Indiana University Hospital	Indianapolis	Indiana
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Ship Drug to: Investigational Drug Services	Indianapolis	Indiana
United States	Springmill Medical Clinic	Indianapolis	Indiana
United States	Wishard Memorial Hospital	Indianapolis	Indiana
United States	Moores UC San Diego Cancer Center	La Jolla	California
United States	UCSD Medical Center -La Jolla	La Jolla	California
United States	Kaiser Permanente	Lafayette	Colorado
United States	NSLIJ Health System/Monter Cancer Center	Lake Success	New York
United States	Cancer Center of South Florida Foundation, Inc.	Lake Worth	Florida
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Tennessee Oncology, PLLC	Lebanon	Tennessee
United States	University of Arkansas for Medical Research, Winthrop Rockefeller Cancer Institute	Little Rock	Arkansas
United States	Drug Shipping Address: [IRB# 10-001530] Ronald Reagan UCLA	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	UCLA Hematology Oncology	Los Angeles	California
United States	UCLA Ophthalmic Oncology Center	Los Angeles	California
United States	University of California, Los Angeles	Los Angeles	California
United States	University of California-Los Angeles	Los Angeles	California
United States	Georgia Cancer Specialists-Macon	Macon	Georgia
United States	Georgia Cancer Specialists-Kennestone	Marietta	Georgia
United States	Monroe Medical Associates	Munster	Indiana
United States	The Community Hospital	Munster	Indiana
United States	Tennessee Oncology, PLLC	Murfreesboro	Tennessee
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	The Vanderbilt Cancer Clinic	Nashville	Tennessee
United States	The Vanderbilt Chemo Pharmacy	Nashville	Tennessee
United States	Clinical Trial Office	New Haven	Connecticut
United States	Drug Shipping for Yale; C/O Thomas Ferenez, RPh, BCOP	New Haven	Connecticut
United States	Smilow Cancer Hospital at Yale New Haven	New Haven	Connecticut
United States	Yale Cancer Center	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavillion	New York	New York
United States	Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians	Oneida	New York
United States	Ship Drug To : Kevin Kong- University of California, Irvine-Pharmacy	Orange	California
United States	University of California, Irvine-Medical Center	Orange	California
United States	Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians	Oswego	New York
United States	Stanford University-Cancer Center	Palo Alto	California
United States	Memorial Cancer Institute (West)	Pembroke Pines	Florida
United States	Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center-Shadyside	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	UC Davis Cancer Center	Sacramento	California
United States	University of California Davis Medical Center	Sacramento	California
United States	UCSD Medical Center- Hillcrest	San Diego	California
United States	Georgia Cancer Specialists	Sandy Springs	Georgia
United States	Santa Monica-UCLA Medical Center and Orthopaedic Hospital	Santa Monica	California
United States	University of California-Los Angeles	Santa Monica	California
United States	Redwood Regional Medical Group, Inc.	Santa Rosa	California
United States	Investigational Drug Service	Seattle	Washington
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Swedish Cancer Institute	Seattle	Washington
United States	Swedish Medical Center	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Tennessee Oncology, PLLC	Smyrna	Tennessee
United States	Barnes-Jewish Hospital	St. Louis	Missouri
United States	Washington University, School of Medicine	St. Louis	Missouri
United States	Siteman Cancer Center	St. Peters	Missouri
United States	Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians	Syracuse	New York
United States	SUNY Upstate Medical University	Syracuse	New York
United States	H Lee Moffitt Cancer Center & Research Institute	Tampa	Florida
United States	Monroe Medical Associates	Tinley Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Bulgaria,  Canada,  China,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Ireland,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.	Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)	No
Secondary	Overall Survival (OS)	OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.	Randomization until death (up to 112 weeks)	No
Secondary	Overall Survival Probability at Month 6 and Month 12	Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method.	Month 6, 12	No
Secondary	Percentage of Participants With Objective Response (OR)	Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis). PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Objective response is based on independent radiology review.	Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)	No
Secondary	Percentage of Participants With Disease Control at Week 6	Disease control: participants with CR, PR, or stable disease (SD) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Disease control is based on independent radiology review.	Week 6	No
Secondary	Percentage of Participants With Disease Control at Week 12	Disease control: participants with CR, PR, or SD according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.	Week 12	No
Secondary	Duration of Response (DR)	Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.02. DR was calculated for the subgroup of participants with a confirmed objective tumor response.	Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)	No
Secondary	Time to Tumor Response (TTR)	Time from date of randomization to first documentation of objective tumor response. TTR was calculated for the subgroup of participants with objective tumor response. Objective tumor response was defined as CR or PR according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.	Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)	No
Secondary	Pre-Dose Plasma Concentration (Ctrough) of Crizotinib	Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.	Pre-dose on Day 1 of Cycle 1, 2, 3, 5	No
Secondary	Pre-Dose Plasma Concentration at Steady State (Ctrough, ss) of Crizotinib	Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.	Pre-dose on Day 15 of Cycle 1	No
Secondary	Number of Participants With Categorical Maximum QTcF for Crizotinib	QT interval corrected using Fridericia's formula (QTcF): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (<) 450 milliseconds (msec), 450 msec to <480 msec, 480 msec to <500 msec, and more than or equal to (>=) 500 msec. A participant is reported only once under the maximum QTcF interval observed at any of the time-points. Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.	Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2	Yes
Secondary	Percentage of Participants With Echinoderm Microtubule Associated Protein-Like 4-Anaplastic Lymphoma Kinase (EML4-ALK) Fusion Variants		Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)	No
Secondary	Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins		Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)	No
Secondary	Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough	TTD in pain (pain in chest from European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer [EORTC QLQ-LC13]), dyspnea (from EORTC QLQ-LC13), or cough (from EORTC QLQ-LC13) symptoms was defined as the time from randomization to the earliest time the participant's score showed a 10 point or higher increase from baseline in any of the three symptoms from the instrument. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 range from 0 to 100, greater scores = higher symptom severity.	Baseline up to end of treatment (up to 112 weeks)	No
Secondary	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	EORTC QLQ-C30: included global health status/quality of life (QoL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of QoL/functioning or higher score for symptom scale=greater degree of symptoms.	Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks)	No
Secondary	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13)	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: 1 'Not at All' to 4 'Very Much'. Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms.	Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)	No
Secondary	European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.	Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)	No

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