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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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


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


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 (patients 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 IGF or the EGF receptor

- Has a known allergy / history of hypersensitivity reaction to any of the treatment
components

- Has poorly controlled diabetes mellitus. Patients with a history of diabetes mellitus
are allowed to participate, provided that their blood glucose is within normal range
(fasting glucose < 160 mg/dL or below the 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 NCI-CTCAE Version 3.0 Grade ≥ 2 peripheral neuropathy

- Has significant third space fluid retention, requiring repeated drainage

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (ORR)

Outcome Description:

ORR is equal to the proportion of participants achieving the best overall response of confirmed partial (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST).

Outcome Time Frame:

Approximately 30 weeks

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

13930

NCT ID:

NCT00870870

Start Date:

March 2009

Completion Date:

May 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Tumors
  • Antibodies, Monoclonal
  • Stage IIIb Metastatic Non-Small Cell Lung Cancer
  • Stage IV Metastatic Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

ImClone Investigational SiteNew York, New York  10021
ImClone Investigational SiteBakersfield, California  93309
ImClone Investigational SiteJacksonville, Florida  32207
ImClone Investigational SiteAtlanta, Georgia  30318
ImClone Investigational SiteDecatur, Illinois  62526
ImClone Investigational SiteCleveland, Ohio  44134
ImClone Investigational SiteBirmingham, Alabama  35233
ImClone Investigational SiteAlbuquerque, New Mexico  87131