Overview

This trial is active, not recruiting.

Condition non small cell lung cancer
Treatments necitumumab, gemcitabine, cisplatin
Phase phase 3
Target EGFR
Sponsor Eli Lilly and Company
Collaborator Parexel
Start date January 2010
End date June 2013
Trial size 1093 participants
Trial identifier NCT00981058, 13909, 2009-013838-25, CP11-0806, I4X-IE-JFCC

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 (IMC-11F8), given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving patient disease than the standard chemotherapy combination alone.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
necitumumab + gemcitabine + cisplatin
necitumumab IMC-11F8
800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal.
gemcitabine Gemzar®
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.
(Active Comparator)
gemcitabine + cisplatin
gemcitabine Gemzar®
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.

Primary Outcomes

Measure
Overall survival time (OS)
time frame: Approximately 31 months

Secondary Outcomes

Measure
Progression-free survival (PFS)
time frame: Approximately 31 months
Objective Response Rate(ORR)
time frame: Approximately 31 months
Time to Treatment Failure (TTF)
time frame: Approximately 31 months
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
Change from baseline in Patient Reported Outcomes (PRO) using the Outcomes Lung Cancer Symptom Scale (LCSS) at 31-months.
time frame: 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
Serum Anti-IMC-11F8 (necitumumab) Antibody Assessment
time frame: 31 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Has histologically or cytologically confirmed squamous NSCLC - Has Stage IV disease at the time of study entry - Measurable or nonmeasurable disease at the time of study entry as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) (patients with only truly nonmeasurable disease are not eligible) - Has resolution to Grade ≤ 1 of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia) - Has adequate hepatic function - Has adequate renal function - Has adequate hematologic function - If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method (failure rate < 1%) during and for 6 months after the treatment period (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method) - If male, the patient is surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period - Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization - Has archived tumor tissue available for analysis of EGFR and KRAS mutation status (by PCR) and EGFR gene copy number (by FISH); minimum of four slides, paraffin-embedded tissue, required Exclusion Criteria: - Has nonsquamous NSCLC (adenocarcinoma/large cell or other) - Has received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor - Has received previous chemotherapy for advanced NSCLC (patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 1 year prior to randomization) - Has undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization - Has undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed) - Has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. Patients who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible - Has superior vena cava syndrome contraindicating hydration - Has current clinically-relevant coronary artery disease or uncontrolled congestive heart failure - Has experienced myocardial infarction within 6 months prior to randomization - Has an ongoing or active infection (requiring antibiotics), including active tuberculosis or known infection with the human immunodeficiency virus - Has a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder - Has any National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0 Grade ≥ 2 peripheral neuropathy - Has significant third space fluid retention, requiring repeated drainage - Has any other serious uncontrolled medical disorders or psychological conditions that would, in the opinion of the investigator, limit the patient's ability to complete the study or sign an informed consent document - Has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab (IMC-11F8), or any other contraindication to one of the administered treatments - Is pregnant or breastfeeding - Has a known history of drug abuse - Has a concurrent active malignancy other than adequately-treated basal cell carcinoma of the skin or preinvasive carcinoma of the cervix. A patient with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ≥ 3 years

Additional Information

Official 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)
Description Multinational, randomized, multicenter, open-label, Phase III study of 1093 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.