This trial is active, not recruiting.

Condition non small cell lung cancer
Treatments pemetrexed, cisplatin, imc-11f8
Phase phase 3
Target EGFR
Sponsor Eli Lilly and Company
Collaborator Quintiles
Start date November 2009
End date November 2012
Trial size 633 participants
Trial identifier NCT00982111, 13908, 2009-012574-12, CP11-0805, I4X-IE-JFCB


The research study is testing the investigational drug necitumumab in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and pemetrexed 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
IMC-11F8 + pemetrexed + cisplatin
pemetrexed Alimta®
500 mg/m2 (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles
75 mg/m2 (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles
imc-11f8 necitumumab
800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion
(Active Comparator)
pemetrexed + cisplatin
pemetrexed Alimta®
500 mg/m2 (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles
75 mg/m2 (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles

Primary Outcomes

Overall survival time (OS)
time frame: Approximately 30 months

Secondary Outcomes

Progression-free survival (PFS)
time frame: Approximately 30 months
Objective response rate (ORR)
time frame: Approximately 30 months
Time to Treatment Failure (TTF)
time frame: Approximately 30 months
Minimum concentration (Cmin) of IMC-11F8
time frame: Day 1 of Cycle 1,2,3,4,5 and 6 prior to 11F8 infusion
Serum Anti-IMC-11F8 Antibody Assessment (immunogenicity)
time frame: 30 months
Change from baseline in Patient Reported Outcomes (PRO) using the European Quality of Life-5 Dimension (EQ-5D) at 30 months.
time frame: 30 months
Change from baseline in Patient-Reported Outcomes (PRO) as measured using the Lung Cancer Symptom Scale (LCSS) at 30 months
time frame: 30 months
EGFR protein expression measured by immunohistochemistry
time frame: 30 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Has histologically or cytologically confirmed nonsquamous (adenocarcinoma/large cell or other) non small cell lung cancer - Has Stage IV disease at the time of study entry - Measurable or nonmeasurable disease (as defined by the Response Evaluation Criteria in Solid Tumors RECIST 1.0) at the time of study entry (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 an Eastern Cooperative Oncology Group performance status score of 0-2 - 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 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 patients 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 Exclusion Criteria: - Has squamous non small cell lung cancer - 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 - 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) - Undergone major surgery or received any investigational therapy in the 4 weeks prior to randomization - 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, potentially precluding protocol compliance - Has 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 The patient has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of 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 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)
Description Multinational, randomized, multicenter, open-label Phase 3 study of 633 patients with advanced, nonsquamous (Stage IV) NSCLC. Patients will be randomized on a 1:1 basis to receive first-line necitumumab plus chemotherapy consisting of pemetrexed and cisplatin in study Arm A, or first-line pemetrexed-cisplatin chemotherapy alone in 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 (computed tomography or magnetic resonance imaging) of disease status 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 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.