Status:
COMPLETED
First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Parexel
PPD Development, LP
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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, given toget...
Detailed Description
Multinational, randomized, multicenter, open-label, Phase III study of 1093 participants (age ≥ 18 years) with histologically- or cytologically-confirmed, stage IV squamous-cell NSCLC, who have receiv...
Eligibility Criteria
Inclusion
- 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) (participants 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 participant is surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period
- Female participants 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
- 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 (participants 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. Participants 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 participant'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 participant with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ≥ 3 years
Key Trial Info
Start Date :
January 7 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
1093 Patients enrolled
Trial Details
Trial ID
NCT00981058
Start Date
January 7 2010
End Date
May 30 2024
Last Update
June 18 2025
Active Locations (182)
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1
ImClone Investigational Site
Chandler, Arizona, United States, 85224
2
ImClone Investigational Site
Fayetteville, Arkansas, United States, 72703
3
ImClone Investigational Site
Sacramento, California, United States, 95816
4
ImClone Investigational Site
Galesburg, Illinois, United States, 61401