Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Phase III Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-407)
Brief Summary: This is a study of carboplatin and paclitaxel or nano particle albumin-bound paclitaxel (nab-paclitaxel) with or without pembrolizumab (MK-3475, KEYTRUDA®) in adults with first line metastatic squamous non-small cell lung cancer (NSCLC).

The primary hypotheses are that treatment with pembrolizumab prolongs: 1) Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by a blinded central imaging vendor compared to placebo, and 2) Overall Survival (OS).

After analysis of interim results was conducted, the protocol was amended (Amendment 5) to allow participants the option to discontinue placebo in the control arm and to switch to pembrolizumab in the event of documented progressive disease as assessed by central review.


Options:
A: Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population (Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)); Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population (Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)); Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population (Baseline until death (up approximately 53 months))
B: Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Up to approximately 19 months); Overall Survival (OS) (Up to approximately 19 months)
C: Percentage of Participants Who Died: PP-ITT (Baseline until death due to any cause (up to approximately 2.25 years)); Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP (Baseline until death due to any cause (up to approximately 2.25 years)); Overall Survival (OS): PP-ITT (Baseline until death due to any cause (up to approximately 2.25 years)); OS: TC1/2/3 or IC1/2/3 Subgroup of PP (Baseline until death due to any cause (up to approximately 2.25 years)); OS: SP-ITT (Baseline until death due to any cause (up to approximately 2.87 years)); OS: TC1/2/3 Or IC1/2/3 Subgroup of SP (Baseline until death from any cause (approximately 2.87 years)); OS: TC2/3 or IC2/3 Subgroup of SP (Baseline until death due to any cause (up to approximately 2.87 years)); OS: TC3 or IC3 Subgroup of SP (Baseline until death due to any cause (up to approximately 2.87 years))
D: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months); Overall Survival (OS) Rate in All Randomized Participants (Randomization to 18 months post-randomization, up to June 2015); Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months)

Answer: B