Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Placebo Plus Erlotinib in Patients With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy

Conditions

• Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• OSI-906 — DRUG
  Tablet administered with food and with up to 200 mL of water
• erlotinib — DRUG
  Tablet administered at least 2 hours after food with up to 200 mL of water
• placebo — DRUG
  Tablet administered at least 2 hours after food with up to 200 mL of water

Study Details

A multicenter, randomized, double-blind, placebo-controlled, phase 2 study with a 1:1 randomization scheme.

Key Dates

First listed

Aug 23, 2010

Start date

Mar 4, 2011

Status verified

Nov 2025

Primary completion

Jul 1, 2013

Completion

Mar 11, 2015

Study Design

Enrollment

205 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: OSI-906 plus erlotinib
  OSI-906 150 mg twice daily (BID) starting on Day 1; erlotinib 150 mg once daily (QD) starting on Day 1
• Placebo Comparator: Arm B: placebo plus erlotinib
  placebo BID starting on Day 1: erlotinib 150 mg QD starting on Day 1

Primary Outcome Measure

The Progression Free Survival (PFS) of maintenance OSI-906 plus erlotinib, or placebo plus erlotinib in patients with nonprogression following four cycles of first-line platinum-based chemotherapy for advanced NSCLC in the overall population [ Time Frame: 22 months ]

Locations (7)

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