- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00870870
A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before
Randomized, Open Label, Stratified Phase 2 Trial of Gemcitabine, Carboplatin, and Cetuximab With Vs. Without IMC-A12 in Chemotherapy-Naive Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alabama
-
Anniston, Alabama, United States, 36207
- ImClone Investigational Site
-
-
California
-
La Jolla, California, United States, 92093
- ImClone Investigational Site
-
Orange, California, United States, 92868
- ImClone Investigational Site
-
-
Florida
-
Orlando, Florida, United States, 32806
- ImClone Investigational Site
-
-
Georgia
-
Atlanta, Georgia, United States, 30341
- ImClone Investigational Site
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- ImClone Investigational Site
-
Chicago, Illinois, United States, 60612
- ImClone Investigational Site
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- ImClone Investigational Site
-
-
New York
-
New York, New York, United States, 10021
- ImClone Investigational Site
-
New York, New York, United States, 10011
- ImClone Investigational Site
-
New York, New York, United States, 10032
- ImClone Investigational Site
-
-
Ohio
-
Cincinnati, Ohio, United States, 45247
- ImClone Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Has histologically or cytologically confirmed, Stage IIIb - IV NSCLC
- Has metastatic disease
- Has a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Has adequate hematologic function
- Has adequate hepatic function
- Has adequate renal function
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion Criteria:
- Has uncontrolled brain metastases
- Has leptomeningeal disease
- Has received previous chemotherapy for NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization)
- Receiving any other investigational agent(s)
- Has a history of treatment with other agents targeting the insulin-like growth factor (IGF) or the epidermal growth factor (EGF) receptor
- Has a known allergy / history of hypersensitivity reaction to any of the treatment components
- Has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range [fasting glucose <160 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN) and hemoglobin A1C≤ 7%] and that they are on a stable dietary or therapeutic regimen for this condition
- Has an uncontrolled intercurrent illness
- Pregnant or lactating
- Has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years
- Has superior vena cava syndrome contraindicating hydration
- Has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure
- Has any National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version (v) 3.0 Grade ≥2 peripheral neuropathy
- Has significant third space fluid retention, requiring repeated drainage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GCiC + IMC-A12 (Gemcitabine/Cisplatin/Cetuximab + Cixutumumab)
Cycles repeat every 3 weeks for first 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met *Cisplatin will replace Carboplatin. Gemcitabine/Carboplatin/Cetuximab (GCC) plus cixutumumab will change to Gemcitabine/Cisplatin/Cetuximab (GCiC) plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab) |
1000 milligrams per square meter (mg/m^2) on Days 1 and 8 of each cycle [First 6 cycles (18 weeks)] 75 mg/m^2 on Day 1 of each cycle [First 6 cycles (18 weeks)] 6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle) [First 6 cycles (18 weeks)]
Other Names:
400 mg/m^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m^2 once per week thereafter [First 6 cycles (18 weeks)]
Other Names:
10 mg/kg IV infusion, administered once every 2 weeks (Maintenance therapy)
Other Names:
500 mg/m^2 IV infusion, administered once every 2 weeks (Maintenance therapy)
Other Names:
Area under the curve (AUC) = 5, Day 1 of each cycle [First 6 cycles (18 weeks)] *Carboplatin will be replaced by Cisplatin |
Active Comparator: GCiC (Gemcitabine/Cisplatin/Cetuximab)
Cycles repeat every 3 weeks for 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met *Cisplatin will replace Carboplatin. GCC plus cixutumumab will change to GCiC plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab) |
1000 milligrams per square meter (mg/m^2) on Days 1 and 8 of each cycle [First 6 cycles (18 weeks)] 75 mg/m^2 on Day 1 of each cycle [First 6 cycles (18 weeks)] 400 mg/m^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m^2 once per week thereafter [First 6 cycles (18 weeks)]
Other Names:
500 mg/m^2 IV infusion, administered once every 2 weeks (Maintenance therapy)
Other Names:
Area under the curve (AUC) = 5, Day 1 of each cycle [First 6 cycles (18 weeks)] *Carboplatin will be replaced by Cisplatin |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Time Frame: Randomization to measured progressive disease (PD) (up to 16.9 months)
|
ORR was defined as the percentage of participants achieving either CR or PR.
Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.0 criteria.
CR was defined as the disappearance of all target and non-target lesions and the normalization of the tumour marker level.
PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Percentage of participants is calculated as a total number of participants with CR or PR / total number of participants treated * 100.
|
Randomization to measured progressive disease (PD) (up to 16.9 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: Randomization to death due to any cause or censor (up to 30.4 months)
|
OS was defined as the duration from the date of randomization to the date of death from any cause.
For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.
|
Randomization to death due to any cause or censor (up to 30.4 months)
|
Progression-Free Survival (PFS)
Time Frame: Randomization to PD or death due to any cause or censor (up to 16.9 months)
|
PFS was defined as the duration from the date of randomization until disease progression or death due to any cause, whichever occurred first.
Response was defined using RECIST, v 1.0 criteria.
PD was defined as having a ≥20% increase in sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions.
For participants who were alive and without disease progression, PFS was censored at the date of last objective tumor assessment.
For participants who did not experience disease progression and were lost to follow-up, PFS was censored at the date of the last objective tumor assessment or the date of last contact.
|
Randomization to PD or death due to any cause or censor (up to 16.9 months)
|
Time To Progression (TTP)
Time Frame: Randomization to months until PD or censor (up to 16.9 months)
|
TTP was defined as the duration from the date of randomization until the date of disease progression.
Response was defined using RECIST v 1.0 criteria.
PD was defined as having a ≥20% increase in the sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions.
For participants without disease progression, TTP was censored at the date of last objective tumor assessment.
For participants without disease progression and were subsequently lost to follow-up, TTP was censored at the date of last follow-up visit or at the date of last contact.
|
Randomization to months until PD or censor (up to 16.9 months)
|
Duration of Response
Time Frame: Date of first response to the date of PD or death due to any cause or censor ( up to 15.5 months)
|
The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of disease progression or death.
Response was defined using RECIST v 1.0 criteria.
CR was defined as the disappearance of all target lesions and non-target lesions.
PR was defined as having at least a 30% decrease in sum of LD of target lesions.
Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of disease progression.
|
Date of first response to the date of PD or death due to any cause or censor ( up to 15.5 months)
|
Number of Participants With Adverse Events (AEs) or Deaths
Time Frame: Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up
|
Data presented are the number of participants who experienced 1 or more AEs, serious AEs (SAEs), and AEs that lead to death during the study including the 30-day follow-up.
A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.
|
Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up
|
Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity)
Time Frame: Prior to first infusions of Cycles 1, 3, and 5 and 30 days following the end of therapy
|
Prior to first infusions of Cycles 1, 3, and 5 and 30 days following the end of therapy
|
|
Maximum Concentration (Cmax) of Cixutumumab at Study Day 1
Time Frame: Day 1
|
Day 1
|
|
Cmax of Cixutumumab for Cycle 1
Time Frame: Week 1 (Cycle 1, Day 1)
|
Week 1 (Cycle 1, Day 1)
|
|
Cmax of Cixutumumab for Cycle 3
Time Frame: Week 7 (Cycle 3, Day 1)
|
Week 7 (Cycle 3, Day 1)
|
|
Cmax of Cixutumumab Cycle 5
Time Frame: Week 13 (Cycle 5, Day 1)
|
Week 13 (Cycle 5, Day 1)
|
|
Minimum Concentration (Cmin) of Cixutumumab at Study Day 1
Time Frame: Day 1
|
Day 1
|
|
Cmin of Cixutumumab for Cycle 1
Time Frame: Week 1 (Cycle 1, Day 1)
|
Week 1 (Cycle 1, Day 1)
|
|
Cmin of Cixutumumab for Cycle 3
Time Frame: Week 7 (Cycle 3, Day 1)
|
Week 7 (Cycle 3, Day 1)
|
|
Cmin of Cixutumumab for Cycle 5
Time Frame: Week 13 (Cycle 5, Day 1)
|
Week 13 (Cycle 5, Day 1)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: E-mail: ClinicalTrials@ ImClone.com, Eli Lilly and Company
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Gemcitabine
- Carboplatin
- Cisplatin
- Antibodies, Monoclonal
- Cetuximab
Other Study ID Numbers
- 13930
- CP02-0860 (Other Identifier: CDER)
- CP13-0811 (Other Identifier: ImClone, LLC)
- I5A-IE-JAEF (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-Small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
Memorial Sloan Kettering Cancer CenterAstraZenecaRecruitingNSCLC | Lung Cancer | Non-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | PD-L1 Gene Mutation | Non-small Cell Lung Cancer Stage IIIA | Non-small Cell Lung Cancer Stage IIUnited States
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)WithdrawnStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on Gemcitabine
-
AstraZenecaRecruitingBiliary Tract CancerFrance, Spain, Italy, Korea, Republic of, Japan, Germany, United States, Singapore
-
Sierra Oncology LLC - a GSK companyCompletedAdvanced Solid TumorsSpain, United Kingdom
-
University of Erlangen-Nürnberg Medical SchoolCompleted
-
Shenzhen University General HospitalNot yet recruiting
-
3D Medicines (Sichuan) Co., Ltd.Not yet recruitingBiliary Tract Neoplasms
-
Kansai Hepatobiliary Oncology GroupCompleted
-
Fifth Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
3D Medicines (Sichuan) Co., Ltd.RecruitingBiliary Tract NeoplasmsChina
-
Air Force Military Medical University, ChinaRecruiting
-
SUNHO(China)BioPharmaceutical CO., Ltd.Recruiting