Please select the arm or intervention descriptions that belong 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: Arm Label: Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: MEL: Pembrolizumab 10 mg/kg Q2W (Part B); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: NSCLC: Pembrolizumab 2 mg/kg Q3W (Part E-Not Enrolled); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: NSCLC: Pembrolizumab 5 mg/kg Q3W (Part E-Not Enrolled); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: NSCLC: Pembrolizumab 10 mg/kg Q3W (Part E-Not Enrolled); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Intervention Type: BIOLOGICAL; Name: Pembrolizumab; Assigned to Arm(s): MEL: Pembrolizumab 10 mg/kg Q2W (Part B), MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D), MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D), NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F), NSCLC: Pembrolizumab 10 mg/kg Q3W (Part E-Not Enrolled), NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F), NSCLC: Pembrolizumab 2 mg/kg Q3W (Part E-Not Enrolled), NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F), NSCLC: Pembrolizumab 5 mg/kg Q3W (Part E-Not Enrolled), Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A), Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1), Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A), Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2), Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2), Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2)
B: Arm Label: Arm A: Nivolumab + Gemcitabine + Cisplatin; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Drug: Gemcitabine, Drug: Cisplatin | Arm Label: Arm B: Nivolumab + Pemetrexed + Cisplatin; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Drug: Cisplatin, Drug: Pemetrexed | Arm Label: Arm C: Nivolumab + Paclitaxel + Carboplatin; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Drug: Paclitaxel, Drug: Carboplatin | Arm Label: Arm D: Nivolumab + Bevacizumab maintenance; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Drug: Bevacizumab | Arm Label: Arm E: Nivolumab + Erlotinib; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Drug: Erlotinib | Arm Label: Arm F: Nivolumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab | Arm Label: Arm G: Nivolumab + Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm H: Nivolumab + Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm I: Nivolumab + Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm J: Nivolumab + Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm K: Nivolumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab | Arm Label: Arm L: Nivolumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab | Arm Label: Arm M: Nivolumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab | Arm Label: Arm N: Nivolumab + Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm O: Nivolumab + Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm P: Nivolumab + Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm Q: Nivolumab + Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm R: Nivolumab + Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm S: Nivolumab + Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Intervention Type: BIOLOGICAL; Name: Nivolumab; Assigned to Arm(s): Arm A: Nivolumab + Gemcitabine + Cisplatin, Arm B: Nivolumab + Pemetrexed + Cisplatin, Arm C: Nivolumab + Paclitaxel + Carboplatin, Arm D: Nivolumab + Bevacizumab maintenance, Arm E: Nivolumab + Erlotinib, Arm F: Nivolumab, Arm G: Nivolumab + Ipilimumab, Arm H: Nivolumab + Ipilimumab, Arm I: Nivolumab + Ipilimumab, Arm J: Nivolumab + Ipilimumab, Arm K: Nivolumab, Arm L: Nivolumab, Arm M: Nivolumab, Arm N: Nivolumab + Ipilimumab, Arm O: Nivolumab + Ipilimumab, Arm P: Nivolumab + Ipilimumab, Arm Q: Nivolumab + Ipilimumab, Arm R: Nivolumab + Ipilimumab, Arm S: Nivolumab + Ipilimumab | Intervention Type: DRUG; Name: Gemcitabine; Assigned to Arm(s): Arm A: Nivolumab + Gemcitabine + Cisplatin | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): Arm A: Nivolumab + Gemcitabine + Cisplatin, Arm B: Nivolumab + Pemetrexed + Cisplatin | Intervention Type: DRUG; Name: Pemetrexed; Assigned to Arm(s): Arm B: Nivolumab + Pemetrexed + Cisplatin | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Arm C: Nivolumab + Paclitaxel + Carboplatin | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Arm C: Nivolumab + Paclitaxel + Carboplatin | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): Arm D: Nivolumab + Bevacizumab maintenance | Intervention Type: DRUG; Name: Erlotinib; Assigned to Arm(s): Arm E: Nivolumab + Erlotinib | Intervention Type: BIOLOGICAL; Name: Ipilimumab; Assigned to Arm(s): Arm G: Nivolumab + Ipilimumab, Arm H: Nivolumab + Ipilimumab, Arm I: Nivolumab + Ipilimumab, Arm J: Nivolumab + Ipilimumab, Arm N: Nivolumab + Ipilimumab, Arm O: Nivolumab + Ipilimumab, Arm P: Nivolumab + Ipilimumab, Arm Q: Nivolumab + Ipilimumab, Arm R: Nivolumab + Ipilimumab, Arm S: Nivolumab + Ipilimumab
C: Arm Label: Pembrolizumab 2 mg/kg; Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Pembrolizumab 10 mg/kg; Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Docetaxel 75 mg/m^2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Docetaxel | Intervention Type: BIOLOGICAL; Name: Pembrolizumab; Assigned to Arm(s): Pembrolizumab 10 mg/kg, Pembrolizumab 2 mg/kg | Intervention Type: DRUG; Name: Docetaxel; Assigned to Arm(s): Docetaxel 75 mg/m^2
D: Arm Label: Arm A: Nivolumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab | Arm Label: Arm B: Docetaxel; Type: EXPERIMENTAL; Interventions: Drug: Docetaxel | Intervention Type: BIOLOGICAL; Name: Nivolumab; Assigned to Arm(s): Arm A: Nivolumab | Intervention Type: DRUG; Name: Docetaxel; Assigned to Arm(s): Arm B: Docetaxel

Answer: C