Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

Conditions

• Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pemetrexed — DRUG
  500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity
• Erlotinib — DRUG
  150 mg given orally (po), daily (QD), starting on the first day of the first cycle
• Pemetrexed — DRUG
  500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
• Erlotinib — DRUG
  150 mg given po, QD, starting on the first day of the first cycle

Study Details

This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival \[PFS\], disease control rate, best response rate, time to treatment failure \[TTTF\], overall survival \[OS\] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.

Key Dates

First listed

Mar 13, 2007

Start date

Mar 31, 2007

Status verified

Sep 2011

Primary completion

Jul 31, 2010

Completion

Jun 30, 2011

Study Design

Enrollment

204 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Pemetrexed (Nonsquamous)
  Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm
• Experimental: Pemetrexed + Erlotinib (Nonsquamous)
  Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm
• Experimental: Pemetrexed (Squamous)
  Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm
• Experimental: Pemetrexed + Erlotinib (Squamous)
  Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months ]