A Study of Necitumumab in the First-Line Treatment of Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

Sponsor
Eli Lilly and Company
Study ID
NCT01763788
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Squamous Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Necitumumab — DRUG
    Administered IV
  • Gemcitabine — DRUG
    Administered IV
  • Cisplatin — DRUG
    Administered IV

Study Details

The purpose of the Phase 1b portion of the study is to investigate how the body tolerates necitumumab, in combination with gemcitabine and cisplatin chemotherapy as first line treatment in participants with Stage IV squamous NSCLC and to determine the recommended dose for the subsequent Phase 2 portion of the study. The purpose of the Phase 2 portion of the study is to evaluate the efficacy of necitumumab in combination with gemcitabine and cisplatin chemotherapy in participants with Stage IV squamous NSCLC in a first-line setting.

Key Dates

Start date
May 7, 2013
Status verified
Dec 2018
Primary completion
Jun 28, 2017
Completion
Oct 17, 2018

Study Design

Enrollment
192 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Necitumumab + Gem and Cis
    Phase 1b Dose Escalation: Necitumumab 800 milligram (mg) on Days 1 and 8 of every 21 day cycle, administered as an intravenous (IV) infusion. Gemcitabine (Gem) dose escalation of 1000 or 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles. Cisplatin (Cis) 75 mg/m\^2 on Day 1 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles. Phase 2 Randomized: Necitumumab 800 mg on Days 1 and 8 of every 21 day cycle, administered as an IV infusion. Gemcitabine at fixed dose determined in Phase 1b (1000 or 1250 mg/m\^2) on Days 1 and 8 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles. Cisplatin 75 mg/m\^2 on Day 1 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles.
  • Active Comparator: Gemcitabine + Cisplatin
    Phase 2 Randomized: Gemcitabine at fixed dose determined in Phase 1b (1000 to 1250 mg/m\^2) on Day 1 and Day 8 of every 21 day cycle,administered as an IV infusion over approximately 30 minutes for a maximum of 4 cycles. Cisplatin 75 mg/m\^2 on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 120 minutes for a maximum of 4 cycles .

Primary Outcome Measure

Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 to Day 21 in Cycle 1 (Up To 21 days) ]

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