Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189)
Brief Summary: This is an efficacy and safety study of pembrolizumab (MK-3475) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned to receive pembrolizumab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin).

With Amendment 10 (effective date 23-Dec-2019), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded, and all participants in the 'control' arm will discontinue saline placebo.

With Amendment 11 (effective date 31-Jan-2022), once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.

The primary hypothesis is that pembrolizumab in combination with pemetrexed/platinum chemotherapy prolongs Progression-Free Survival (PFS) and Overall Survival (OS) compared to pemetrexed/platinum chemotherapy alone.


Options:
A: Intervention Type: DRUG; Name: carboplatin; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: cisplatin; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: gemcitabine hydrochloride; Assigned to Arm(s): N/A
B: Arm Label: Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed; Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab 200 mg, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Dietary Supplement: Folic acid 350-1000 μg, Dietary Supplement: Vitamin B12 1000 μg, Drug: Dexamethasone 4 mg | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Dietary Supplement: Folic acid 350-1000 μg, Dietary Supplement: Vitamin B12 1000 μg, Drug: Dexamethasone 4 mg, Drug: Saline solution | Intervention Type: BIOLOGICAL; Name: Pembrolizumab 200 mg; Assigned to Arm(s): Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): Control, Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Control, Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed | Intervention Type: DRUG; Name: Pemetrexed; Assigned to Arm(s): Control, Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed | Intervention Type: DIETARY_SUPPLEMENT; Name: Folic acid 350-1000 μg; Assigned to Arm(s): Control, Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin B12 1000 μg; Assigned to Arm(s): Control, Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed | Intervention Type: DRUG; Name: Dexamethasone 4 mg; Assigned to Arm(s): Control, Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed | Intervention Type: DRUG; Name: Saline solution; Assigned to Arm(s): Control
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Cisplatin, Drug: Gemcitabine, Drug: bevacizumab [Avastin] | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Cisplatin, Drug: Gemcitabine, Drug: bevacizumab [Avastin] | Arm Label: 3; Type: PLACEBO_COMPARATOR; Interventions: Drug: Cisplatin, Drug: Gemcitabine, Drug: Placebo | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): 1, 2, 3 | Intervention Type: DRUG; Name: Gemcitabine; Assigned to Arm(s): 1, 2, 3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: bevacizumab [Avastin]; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: bevacizumab [Avastin]; Assigned to Arm(s): 2
D: Arm Label: Arm I (paclitaxel and carboplatin); Type: EXPERIMENTAL; Interventions: Drug: paclitaxel, Drug: carboplatin, Other: laboratory biomarker analysis | Arm Label: Arm II (paclitaxel, carboplatin, and bevacizumab); Type: EXPERIMENTAL; Interventions: Drug: paclitaxel, Drug: carboplatin, Biological: bevacizumab, Other: laboratory biomarker analysis | Intervention Type: DRUG; Name: paclitaxel; Assigned to Arm(s): Arm I (paclitaxel and carboplatin), Arm II (paclitaxel, carboplatin, and bevacizumab) | Intervention Type: DRUG; Name: carboplatin; Assigned to Arm(s): Arm I (paclitaxel and carboplatin), Arm II (paclitaxel, carboplatin, and bevacizumab) | Intervention Type: BIOLOGICAL; Name: bevacizumab; Assigned to Arm(s): Arm II (paclitaxel, carboplatin, and bevacizumab) | Intervention Type: OTHER; Name: laboratory biomarker analysis; Assigned to Arm(s): Arm I (paclitaxel and carboplatin), Arm II (paclitaxel, carboplatin, and bevacizumab)

Answer: B