Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus.

简要总结

主要结局

次要结局

• Overall Survival (OS)(From randomization to death or last date known alive for those not known to have died (up to 72 months))
• Overall Survival Probability at Month 12 and 18(Month 12, 18)
• Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR(Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months))
• Duration of Response (DR) Based on IRR(From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months))
• Time to Tumor Response (TTR) Based on IRR(Randomization to first documentation of objective tumor response (up to 35 months))
• Percentage of Participants With Disease Control at Week 12 Based on IRR(Week 12)
• Time to Progression (TTP) Based on IRR(Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months))
• Time to Intracranial Progression (IC-TTP) Based on IRR(Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months))
• Time to Extracranial Progression (EC-TTP) Based on IRR(Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months))
• Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to follow up period (up to 72 months))
• Percentage of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to follow up period (up to 72 months))
• Percentage of Participants With Adverse Events (AEs) According to Maximum Severity(Baseline up to follow up period (up to 72 months))
• Plasma Predose Concentration (Ctrough) of Crizotinib and Its Metabolite PF-06260182(Predose at Day 1 of Cycle 2, 3 and 5)
• Percentage of Participants For Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants(28 days prior to day 1 of study treatment)
• Objective Response Rate (ORR) of Anaplastic Lymphoma Kinase (ALK) Variant Groups Based on IRR(Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months))
• Time to Deterioration (TTD) in Chest Pain, Dyspnea or Cough(From randomization of treatment up to deterioration while on study treatment (up to 35 months))
• Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)(Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months))
• Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)(Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months))
• Change From Baseline in Lung Cancer Symptom Scores as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)(Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months))
• Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS)(Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months))
• Percentage of Participants With Hospital Admissions-Healthcare Resource Utilization (HCRU)(Baseline up to follow up period (up to 72 months))
• Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Hematological Test Abnormalities(Baseline up to follow up period (up to 72 months))
• Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Chemistry Test Abnormalities(Baseline up to follow up period (up to 72 months))