Randomized, Open-Label, Phase 3 Study of Pemetrexed Plus Carboplatin and Bevacizumab Followed by Maintenance Pemetrexed and Bevacizumab Versus Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB or IV Nonsquamous Non-Small Cell Lung Cancer

简要总结

主要结局

次要结局

• Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate)(Baseline to measured progressive disease (up to 37.06 months))
• Safety and Toxicity Profile of Study Treatments(Baseline to study endpoint (up to 37.06 months))
• Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-Ntx)(Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days))
• Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Total (Bound and Unbound) Platinum and Unbound Platinum(Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose))
• Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) Bevacizumab(Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose))
• Pharmacokinetics (PK): Bevacizumab Clearance (CL)(Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose))
• Time to Progressive Disease(Baseline to measured progressive disease (up to 37.06 months))
• Duration of Hospitalizations Per Participant(Baseline to study endpoint (up to 37.06 months))
• Number of Participants Who Received a Transfusion(Baseline to study endpoint (up to 37.06 months))
• Number of Participants Receiving Concomitant Medication(Baseline to study endpoint (up to 37.06 months))
• Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)(Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days))
• Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Lung (FACT-L)(Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days))
• Pharmacokinetics (PK): Elimination Half-life (t1/2) for Bevacizumab(Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose))
• Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)(Baseline to measured progressive disease (up to 37.06 months))
• Progression Free Survival Time(Baseline to measured progressive disease or date of death from any cause (up to 33.54 months))
• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Pemetrexed(Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose))
• Pharmacokinetics (PK): Elimination Half-life (t1/2) for Pemetrexed(Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose))
• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Total (Bound and Unbound) Platinum and Unbound Platinum(Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose))
• Pharmacokinetics (PK): Elimination Half-life (t1/2) for Total (Bound and Unbound) Platinum and Unbound Platinum(Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose))
• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Bevacizumab(Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose))
• Translational Research: Overall Survival (OS) Based on Cytoplasmic and Nuclear Thymidylate Synthase (TS) Expression(Baseline to date of death from any cause (up to 37.06 months))
• Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Pemetrexed(Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose))
• Pharmacokinetics (PK): Pemetrexed Clearance (CL)(Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose))
• Translational Research: Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations(Baseline)
• Pharmacokinetics (PK): Platinum Clearance (CL) for Total (Bound and Unbound) and Unbound Forms(Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose))
• Translational Research: Overall Survival (OS) Based on Nuclear Thyroid Transcription Factor-1 (TTF-1) Expression Regardless of Study Treatment(Baseline to date of death from any cause (up to 37.06 months))
• Translational Research: Overall Survival (OS) Based on Cytoplasmic and Membrane Folate Receptor Alpha (FR-α) Expression(Baseline to date of death from any cause (up to 37.06 months))