Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-small-cell lung cancer (NSCLC)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 45
Healthy volunteers: no

Brief summary:
This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.

This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).

Detailed description:

Arms:
arm 1: Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment arm 2: Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment

Interventions: intervention 1: Erlotinib intervention 2: Chemotherapy
Intervention descriptions: intervention 1: 150 mg oral dose of erlotinib given once daily intervention 2: Cisplatin (75 mg/m\^2 intravenously \[IV\]) on Day 1 and gemcitabine (1250 mg/m\^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first)

Protocol document: