Clinical trial NCT00981058
Conditions: Non Small Cell Lung Cancer
Keywords: Squamous Non Small Cell Lung Cancer First line treatment Monoclonal Antibodies Epidermal Growth Factor Receptor (EGFR)
Sponsor: Eli Lilly and Company
Start date: 2010-01-07; Completion date: 2024-05-30
Enrollment: 1093 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.

Detailed description:
Multinational, randomized, multicenter, open-label, Phase III study of 1093 participants (age ≥ 18 years) with histologically- or cytologically-confirmed, stage IV squamous-cell NSCLC, who have received no prior therapy for metastatic disease, will be randomized on a 1:1 basis to receive first-line necitumumab plus chemotherapy consisting of gemcitabine and cisplatin in study Arm A, or gemcitabine-cisplatin chemotherapy alone in study Arm B. Baseline radiographic assessment of disease will be performed within 21 days prior to randomization (first treatment will be administered within 7 days following randomization). Participants will undergo radiographic assessment of disease status (computed tomography or magnetic resonance imaging) every 6 weeks (± 3 days), until there is radiographic documentation of progressive disease (PD). Chemotherapy will continue for a maximum of six cycles in each arm (or until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance or withdrawal of consent); participants in Arm A only will continue to receive necitumumab until there is radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.

After the end-of-study-visit (following PD), follow-up information regarding further anticancer treatment and survival will be collected every 2 months (± 7 days). For participants who discontinue study for reasons other than PD (eg, symptomatic deterioration), information on disease progression will also be collected until PD is documented. Follow-up will continue as long as the participant is alive, or until the end of the trial.

Arms: arm 1: Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle.

Continues until progressive disease, toxicity, noncompliance, or withdrawal.

Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle.

Continues for a maximum of six cycles.

Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles. arm 2: Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles.

Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles.
Interventions: intervention 1: Necitumumab intervention 2: Gemcitabine intervention 3: Cisplatin
Intervention descriptions: intervention 1: Administered intravenously.

Continues until progressive disease, toxicity, noncompliance, or withdrawal. intervention 2: Administered intravenously.

Continues for a maximum of six cycles. intervention 3: Administered intravenously.

Continues for a maximum of six cycles.

Protocol documents: