Conditions: Non Small Cell Lung Cancer
Keywords: Recurrent or Progressive Non-Small Cell Lung Cancer Second-line therapy Docetaxel Pemetrexed Cetuximab Failed platinum-based therapy NSCLC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 939
Healthy volunteers: no

Brief summary:
This trial is a multicenter, open-label, randomized, Phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy. Patients will receive either Docetaxel or Pemetrexed as chemotherapy at the investigator's choice. Within each chemotherapy group, patients will be randomized to receive Cetuximab plus chemotherapy or chemotherapy alone (Cetuximab \& Pemetrexed or Pemetrexed alone; Cetuximab \& Docetaxel or Docetaxel alone).

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Pemetrexed intervention 2: Cetuximab intervention 3: Docetaxel
Intervention descriptions: intervention 1: Pemetrexed 500 mg/m\^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles. intervention 2: Cetuximab 400/250 mg/m\^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. intervention 3: Docetaxel 75 mg/m\^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.

Protocol document: