Conditions: Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.
Keywords: nonsquamous
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 204
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm arm 2: Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm arm 3: Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm arm 4: Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm

Interventions: intervention 1: Pemetrexed intervention 2: Erlotinib intervention 3: Pemetrexed intervention 4: Erlotinib
Intervention descriptions: intervention 1: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity intervention 2: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle intervention 3: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity intervention 4: 150 mg given po, QD, starting on the first day of the first cycle

Protocol document: