A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before

NCT00870870 | Completed Phase 2 Results

• 4 other identifiers: 13930CP02-0860CP13-0811I5A-IE-JAEF
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.

Conditions

Non-Small Cell Lung Cancer

Keywords

Tumors; Antibodies, Monoclonal; Stage IIIb Metastatic Non-Small Cell Lung Cancer; Stage IV Metastatic Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

  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 Outcomes (14)

• Overall Survival (OS)

  Randomization to death due to any cause or censor (up to 30.4 months)

• Progression-Free Survival (PFS)

  Randomization to PD or death due to any cause or censor (up to 16.9 months)

• Time To Progression (TTP)

  Randomization to months until PD or censor (up to 16.9 months)

• Duration of Response

  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

  Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up

Study Arms (2)

GCiC + IMC-A12 (Gemcitabine/Cisplatin/Cetuximab + Cixutumumab)

EXPERIMENTAL

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)

Drug: Gemcitabine; Drug: Cisplatin; Biological: IMC-A12 (cixutumumab); Biological: Cetuximab; Drug: Carboplatin

GCiC (Gemcitabine/Cisplatin/Cetuximab)

ACTIVE COMPARATOR

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)

Drug: Gemcitabine; Drug: Cisplatin; Biological: Cetuximab; Drug: Carboplatin

Interventions

Gemcitabine DRUG

1000 milligrams per square meter (mg/m\^2) on Days 1 and 8 of each cycle \[First 6 cycles (18 weeks)\]

GCiC (Gemcitabine/Cisplatin/Cetuximab); GCiC + IMC-A12 (Gemcitabine/Cisplatin/Cetuximab + Cixutumumab)

Cisplatin DRUG

75 mg/m\^2 on Day 1 of each cycle \[First 6 cycles (18 weeks)\]

GCiC (Gemcitabine/Cisplatin/Cetuximab); GCiC + IMC-A12 (Gemcitabine/Cisplatin/Cetuximab + Cixutumumab)

IMC-A12 (cixutumumab) BIOLOGICAL

6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle) \[First 6 cycles (18 weeks)\]

Also known as: Cixutumumab, LY3012217

GCiC + IMC-A12 (Gemcitabine/Cisplatin/Cetuximab + Cixutumumab)

Cetuximab BIOLOGICAL

400 mg/m\^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m\^2 once per week thereafter \[First 6 cycles (18 weeks)\]

Also known as: Erbitux®

GCiC (Gemcitabine/Cisplatin/Cetuximab); GCiC + IMC-A12 (Gemcitabine/Cisplatin/Cetuximab + Cixutumumab)

Carboplatin DRUG

Area under the curve (AUC) = 5, Day 1 of each cycle \[First 6 cycles (18 weeks)\] \*Carboplatin will be replaced by Cisplatin

GCiC (Gemcitabine/Cisplatin/Cetuximab); GCiC + IMC-A12 (Gemcitabine/Cisplatin/Cetuximab + Cixutumumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (12)

ImClone Investigational Site

Anniston, Alabama, 36207, United States

Location

ImClone Investigational Site

La Jolla, California, 92093, United States

Location

ImClone Investigational Site

Orange, California, 92868, United States

Location

ImClone Investigational Site

Orlando, Florida, 32806, United States

Location

ImClone Investigational Site

Atlanta, Georgia, 30341, United States

Location

ImClone Investigational Site

Chicago, Illinois, 60612, United States

Location

ImClone Investigational Site

Chicago, Illinois, 60637, United States

Location

ImClone Investigational Site

Albuquerque, New Mexico, 87131, United States

Location

ImClone Investigational Site

New York, New York, 10011, United States

Location

ImClone Investigational Site

New York, New York, 10021, United States

Location

ImClone Investigational Site

New York, New York, 10032, United States

Location

ImClone Investigational Site

Cincinnati, Ohio, 45247, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Gemcitabine; Cisplatin; cixutumumab; Cetuximab; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• E-mail: ClinicalTrials@ ImClone.com

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 1, 2018
• Results First Posted: June 1, 2018

Record last verified: 2018-05

Locations

US (12)