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Lung (Non-Small Cell)

A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients with Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

Unique Dataset IDLungNo_EliLill_2010_272
DownloadableYes
SponsorEli LillyData ProviderEli LillyTotal Study Enrolled Patients1093Comparator (Control) Arm Enrolled Patients548RandomizationYesClinicalTrial.gov IDNCT00981058ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00981058
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyDataset TypeOther

Clinical Trial Title

A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients with Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

Trial Summary and Conditions

This multinational, randomized, multicenter, open-label, Phase 3 study was to enroll approximately 1080 patients with histologically or cytologically confirmed Stage IV squamous NSCLC. Patients were randomized on a 1:1 basis to the GC+N Arm or the GC Arm. Randomization was stratified by ECOG PS (0-1 vs. 2) and geographic region (North America, Europe, and Australia vs. South America, South Africa, and India vs. Eastern Asia). Patients in the GC+N Arm received the following: -Necitumumab: 800 mg (absolute dose, intravenous [I.V.]) on Days 1 and 8 of each 3 week cycle -Gemcitabine: 1250 mg/m2 (I.V.) on Days 1 and 8 of each 3-week cycle (maximum of 6 cycles) -Cisplatin: 75 mg/m2 (I.V.) on Day 1 of each 3-week cycle (maximum of 6 cycles) Patients in the GC Arm received: -Gemcitabine: 1250 mg/m2 (I.V.) on Days 1 and 8 of each 3-week cycle (maximum of 6 cycles) -Cisplatin: 75 mg/m2 (I.V.) on Day 1 of each 3-week cycle (maximum of 6 cycles) Patients in the GC+N Arm received necitumumab in combination with gemcitabine and cisplatin chemotherapy for a maximum of 6 cycles, or until there was radiographic documentation of progressive disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent. Patients in the GC Arm continued to receive gemcitabine and cisplatin chemotherapy for a maximum of 6 cycles, or until there was radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.

Data Summary

Efficacy, safety, demographics, concomitant medications, etc. data of control arm are provided.

Study Objectives

Primary Objective: The primary objective of this study was to evaluate the overall survival (OS) in patients with Stage IV squamous NSCLC (per the American Joint Committee on Cancer [AJCC] Staging Manual, Seventh Edition [AJCC7]) treated with necitumumab plus gemcitabine and cisplatin chemotherapy (GC+N Arm) versus gemcitabine and cisplatin chemotherapy alone (GC Arm) in the first-line metastatic setting. Key Secondary Objectives: To evaluate progression-free survival (PFS) in each arm; to evaluate the objective response rate (ORR) in each arm; to evaluate the time to treatment failure (TTF) in each arm; to evaluate the safety profile of necitumumab in combination with gemcitabine and cisplatin chemotherapy;

Outcome Measures

Overall survival; progression-free survival (PFS); objective response rate (ORR); time to treatment failure (TTF); the safety data.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: V6-0 Protocol CP11-0806-redact_v3.pdf

CRF: jfcc_acrf_redacted.pdf

DATA DICTIONARY: jfcc_adam_define_redacted.pdf

DATA (COMPARATOR ARM): jfcc_deid_ctrl_trt.zip