Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer
Brief Summary: This study compared two doses of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) who had experienced disease progression after platinum-containing systemic therapy. Participants were assigned randomly to receive either pembrolizumab 2 mg/kg once every three weeks (Q3W), pembrolizumab 10 mg/kg Q3W or docetaxel 75 mg/m\^2 Q3W. The total number of participants randomized depended upon demonstration of sufficient objective responses at an interim analysis.

Eligible participants who were allocated to the first course of pembrolizumab (2 mg/kg Q3W or 10 mg/kg Q3W) and experienced disease progression, to be permitted to receive a second course of pembrolizumab as long as Inclusion/Exclusion criteria were met.

Protocol Amendment 12 (effective date: 09 Dec 2015) enabled eligible participants who were allocated to docetaxel and experienced disease progression, to be permitted to switch over to receive pembrolizumab 2 mg/kg Q3W as long as Inclusion/Exclusion criteria were met.

With Protocol Amendment 15 (effective date: 03 Jan 2018), all second course and switch over participants will receive pembrolizumab 200 mg Q3W. Response or progression during the second and switch over pembrolizumab courses will not count towards efficacy outcome measures, and adverse events during the second and switch over pembrolizumab courses will not count towards safety outcome measures.

Also with Amendment 15, once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and enrolled in an extension study (Keynote 587; NCT03486873) to continue protocol-defined assessments and treatment. Switch over participants who have not transitioned to pembrolizumab will be considered for the extension study on a case-by-case basis.

The primary study hypotheses are that pembolizumab prolongs Overall Survival (OS) and Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by independent radiologists' review in previously-treated participants with NSCLC in the strongly positive programmed cell death ligand 1 (PD-L1) stratum compared to docetaxel and in participants whose tumors express PD-L1 compared to docetaxel.


Options:
A: Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥50% (Up to approximately 44 months); Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥20% (Up to approximately 44 months); Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥1% (Up to approximately 44 months)
B: Overall Survival (OS) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Experiencing Adverse Events (AEs) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Discontinuing Study Drug Due to AEs (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months))
C: Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death (From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)); Number of Participants Who Experienced Selected Adverse Events (From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)); Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests (From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)); Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests (From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months))
D: Overall survival (OS) (approximately 48 months); Progression-free Survival (PFS) as determined by blinded independent central review (BICR) (approximately 40 months)

Answer: B