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

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00870870

CP02-0860 (Other Identifier)

13930

CP13-0811 (Other Identifier)

I5A-IE-JAEF (Other Identifier)

Details and patient eligibility

About

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

Full description

Participants with Stage IIIb or IV non-small cell lung cancer (NSCLC) who have not received previous chemotherapy will be stratified, based on disease histology (squamous versus [vs.] nonsquamous).

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

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

Experimental group

Description:

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)

Treatment:

Drug: Carboplatin

Biological: Cetuximab

Biological: Cetuximab

Biological: IMC-A12 (cixutumumab)

Drug: Gemcitabine

Drug: Cisplatin

Biological: IMC-A12 (cixutumumab)

GCiC (Gemcitabine/Cisplatin/Cetuximab)

Active Comparator group

Description:

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)

Treatment:

Drug: Carboplatin

Biological: Cetuximab

Biological: Cetuximab

Drug: Gemcitabine

Drug: Cisplatin