A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before
The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 5 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 1, 2018 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Eli Lilly and Company
- Interventions being studied
- Drug: Gemcitabine; Drug: Cisplatin; Biological: IMC-A12 (cixutumumab); Biological: Cetuximab; Biological: IMC-A12 (cixutumumab); Biological: Cetuximab; Drug: Carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- ImClone Investigational SiteAnniston, Alabama
- ImClone Investigational SiteLa Jolla, California
- ImClone Investigational SiteOrange, California
- ImClone Investigational SiteOrlando, Florida
- ImClone Investigational SiteAtlanta, Georgia
- ImClone Investigational SiteChicago, Illinois
- ImClone Investigational SiteChicago, Illinois
- ImClone Investigational SiteAlbuquerque, New Mexico
- ImClone Investigational SiteNew York, New York
- ImClone Investigational SiteNew York, New York
- ImClone Investigational SiteNew York, New York
- ImClone Investigational SiteCincinnati, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 1, 2018. Always confirm current availability with the study team.