Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Squamous
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17
Healthy volunteers: no

Brief summary:
This study will assess the safety and tolerability, and make a preliminary assessment of activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed on at least one prior chemotherapy regimen. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is less than 100 individuals.

Detailed description:

Arms:
arm 1: Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, followed by a dose of 420 mg every 3 weeks. Erlotinib will be administered daily, at a dose level of 100 mg orally (PO). arm 2: Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, followed by a dose of 420 mg every 3 weeks. Erlotinib will be administered daily, at a dose level of 150 mg orally (PO).

Interventions: intervention 1: Erlotinib intervention 2: Pertuzumab
Intervention descriptions: intervention 1: Erlotinib will be administered as oral tablets. intervention 2: Pertuzumab will be administered as intravenous (IV) infusion.

Protocol document: