Conditions: NSCLC (Advanced Non-small Cell Lung Cancer)
Keywords: Lung cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 222
Healthy volunteers: no

Brief summary:
This is a Phase 1b/2 study. In Phase 1b, subjects will know the treatment they are receiving. Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if adding U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung cancer who fail prior treatment. In the Phase 2 portion, subjects will be blinded to the treatments they are receiving. Subjects will receive either Erlotinib alone or Erlotinib + U3-1287.

The Phase 2 portion will determine if adding U3-1287 to Erlotinib will be safe and improve survival in subjects with advanced non-small cell lung cancer who failed the first treatment.

Detailed description:

Arms:
arm 1: U3-1287 (high dose) intravenously (IV) every three weeks (Q3W) + Erlotinib 150 mg/day orally (PO) until cancer gets worse, side effects become unacceptable or participant withdraws consent arm 2: U3-1287 (low dose) IV Q3W + Erlotinib 150 mg/day PO until cancer gets worse, side effects become unacceptable or participant withdraws consent arm 3: Placebo matching U3-1287 IV Q3W + Erlotinib150 mg/day PO until cancer gets worse, side effects become unacceptable or participant withdraws consent

Interventions: intervention 1: U3-1287 intervention 2: Erlotinib intervention 3: Placebo
Intervention descriptions: intervention 1: Liquid 70 mg/mL for IV infusion at high dose or low dose intervention 2: Tablet 150 mg for oral administration intervention 3: Placebo liquid matching U3-1287 for IV infusion

Protocol document: