First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (SQUIRE)

• Kaplan-Meier Estimate for Overall survival time (OS) [ Time Frame: Approximately 31 months ] [ Designated as safety issue: No ]
  Overall survival time is measured as randomization to date of death from any cause. Participants who are alive when the study achieves 844 deaths or is lost to follow-up will have their overall survival time censored on the last date the participant is known to be alive.
  
  

• Kaplan-Meier Estimate for Progression-free survival (PFS) [ Time Frame: Approximately 31 months ] [ Designated as safety issue: No ]
  PFS is measured from randomization to the first radiographically documented progressive disease (PD) or death. Participants alive and without disease progression or lost to follow-up will be censored to the day of their last radiographic assessment.
  
  
• Objective Response Rate(ORR) [ Time Frame: Approximately 31 months ] [ Designated as safety issue: No ]
  Proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR) compared to the total number of participants. Best response is categorized using the Response Evaluation Criteria In Solid Tumors (RECIST) (ver 1.0) guidelines.
  
  
• Time to Treatment Failure (TTF) [ Time Frame: Approximately 31 months ] [ Designated as safety issue: No ]
  TTF is defined as the time from the date of randomization until the date of the first radiographic documentation of PD, death due to any cause, discontinuation of treatment for any reason, or initiation of new cancer therapy.
  
  
• Summary Listing of Participants Reporting Treatment-Emergent Adverse Events [ Time Frame: Approximately 31 months ] [ Designated as safety issue: Yes ]
  Number of participants with adverse events (AEs) collected from Day 1 [start of IMC-11F8 (necitumumab) in combination with gemcitabine-cisplatin] until 30 days after the last dose of therapy or resolution of study-related AEs. AEs will be summarized by MedRRA System Organ Class and predefined term.
  
  
• Change from baseline in Patient Reported Outcomes (PRO) using the European Quality of Life-5 Dimension (EQ-5D) at 31-months [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  Change from baseline to the end of therapy visit approximately 31-months.
  
  
• Change from baseline in Patient Reported Outcomes (PRO) using the Outcomes Lung Cancer Symptom Scale (LCSS) at 31-months. [ Time Frame: 31 months ] [ Designated as safety issue: No ]
  Change from baseline to the end of therapy visit approximately 31-months.
  
  
• Minimum concentration (Cmin) of IMC-11F8 [ Time Frame: Day 1 of Cycle 1, 2, 3, 4, 5 and 6 prior to 11F8 drug infusion ] [ Designated as safety issue: No ]
  
• Serum Anti-IMC-11F8 (necitumumab) Antibody Assessment [ Time Frame: 31 months ] [ Designated as safety issue: Yes ]
  Number of participants who showed detectable levels of antibody at any point in the study
  
  

Approximately 1080 patients (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 (IMC-11F8) 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). Patients 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); patients in Arm A only will continue to receive necitumumab (IMC-11F8) 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 patients 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 patient is alive, or until the end of the trial.