Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-blind Phase III Study of the Effect of First-line Treatment With Intercalated Tarceva Versus Placebo in Combination With Gemcitabine/Platinum on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer
Brief Summary: This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Options:
A: Arm Label: erlotinib; Type: EXPERIMENTAL; Interventions: Drug: erlotinib | Arm Label: gemcitabine/carboplatin; Type: ACTIVE_COMPARATOR; Interventions: Drug: gemcitabine/carboplatin | Intervention Type: DRUG; Name: erlotinib; Assigned to Arm(s): erlotinib | Intervention Type: DRUG; Name: gemcitabine/carboplatin; Assigned to Arm(s): gemcitabine/carboplatin
B: Arm Label: AZD9291+ placebo; Type: EXPERIMENTAL; Interventions: Drug: AZD9291 80 mg/40 mg + placebo, Drug: Placebo Erlotinib 150/100mg, Drug: Placebo Gefitinib 250 mg | Arm Label: Standard of Care + placebo AZD9291; Type: ACTIVE_COMPARATOR; Interventions: Drug: Erlotinib 150/100 mg, Drug: Gefitinib 250 mg, Drug: Placebo AZD9291 80 mg/ 40 mg | Intervention Type: DRUG; Name: AZD9291 80 mg/40 mg + placebo; Assigned to Arm(s): AZD9291+ placebo | Intervention Type: DRUG; Name: Placebo Erlotinib 150/100mg; Assigned to Arm(s): AZD9291+ placebo | Intervention Type: DRUG; Name: Placebo Gefitinib 250 mg; Assigned to Arm(s): AZD9291+ placebo | Intervention Type: DRUG; Name: Erlotinib 150/100 mg; Assigned to Arm(s): Standard of Care + placebo AZD9291 | Intervention Type: DRUG; Name: Gefitinib 250 mg; Assigned to Arm(s): Standard of Care + placebo AZD9291 | Intervention Type: DRUG; Name: Placebo AZD9291 80 mg/ 40 mg; Assigned to Arm(s): Standard of Care + placebo AZD9291
C: Arm Label: Erlotinib; Type: EXPERIMENTAL; Interventions: Drug: Erlotinib | Arm Label: Chemotherapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Chemotherapy | Intervention Type: DRUG; Name: Erlotinib; Assigned to Arm(s): Erlotinib | Intervention Type: DRUG; Name: Chemotherapy; Assigned to Arm(s): Chemotherapy
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Platinum chemotherapy (cisplatin or carboplatin), Drug: erlotinib [Tarceva], Drug: gemcitabine | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Platinum chemotherapy (cisplatin or carboplatin), Drug: gemcitabine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Platinum chemotherapy (cisplatin or carboplatin); Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: erlotinib [Tarceva]; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: gemcitabine; Assigned to Arm(s): 1, 2

Answer: D