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Lung (Non-Small Cell)

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

Unique Dataset IDLungNo_EliLill_2009_323ClinicalTrial.gov IDNCT00982111
DownloadableNo
SponsorEli LillyData ProviderEli LillyTotal Study Enrolled Patients633Comparator (Control) Arm Enrolled Patients318RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapy, BiologicsDataset TypeOther

Clinical Trial Title

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

Trial Summary and Conditions

Primary Objective The primary objective of this study was to evaluate the overall survival (OS) in patients with Stage IV nonsquamous NSCLC (per the American Joint Committee on Cancer [AJCC] Staging Manual, Seventh Edition) treated with necitumumab plus pemetrexed and cisplatin chemotherapy (PC+N Arm) versus pemetrexed and cisplatin chemotherapy alone (PC Arm) in the first-line metastatic setting. Secondary Objectives The secondary objectives of this study were: - 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 pemetrexed and cisplatin chemotherapy; - To evaluate the pharmacokinetics (PK) of necitumumab (PC+N Arm only); - To determine the immunogenicity of necitumumab (PC+N Arm only); - To evaluate Health Status; and - To evaluate the relationship between EGFR protein expression (as measured by immunohistochemistry [IHC]) and efficacy.

Data Summary

Control arm data contains, demographics, treatment exposure, efficacy, vital signs, conmed and safety ADAM data

Study Objectives

Primary Objective: The primary objective of this study was to evaluate the overall survival (OS) in patients with Stage IV nonsquamous NSCLC (per the American Joint Committee on Cancer [AJCC] Staging Manual, Seventh Edition) treated with necitumumab plus pemetrexed and cisplatin chemotherapy (PC+N Arm) versus pemetrexed and cisplatin chemotherapy alone (PC Arm) in the first-line metastatic setting. Secondary Objectives The secondary objectives of this study were: - 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 pemetrexed and cisplatin chemotherapy; - To evaluate the pharmacokinetics (PK) of necitumumab (PC+N Arm only); - To determine the immunogenicity of necitumumab (PC+N Arm only); - To evaluate Health Status.

Outcome Measures

Overall survival (OS); progression-free survival (PFS); objective response rate (ORR); time to treatment failure (TTF) in each arm; the safety profile of necitumumab in combination with pemetrexed and cisplatin chemotherapy.

Available Downloads:

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

PROTOCOL: JFCB 05 Protocol (7)-redact V2.pdf

CRF: JFCB_aCRF_redacted.pdf

DATA DICTIONARY: JFCB_ADaM_specification.xlsx

DATA (COMPARATOR ARM): jfcb_deid_ctrl_trt.zip

OTHER: JFCB_Proc_Contents.pdf