Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

Completed · Phase 2 · Has a placebo group

Conditions studied: Lung Cancer, Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung

In brief

The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.

Key facts

Study ID

NCT00527735

Run by

Bristol-Myers Squibb

People needed

334

Starts

2008-02-01

Expected to finish

2011-12-01

Last updated by the study team

2018-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer [SCLC])
• Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria
• Eastern Cooperative Oncology Group performance status of ≤1 at study entry
• Accessible for treatment and follow-up

You may not qualify if…

• Brain metastases
• Malignant pleural effusion
• Autoimmune disease
• Motor neuropathy of autoimmune origin
• SCLC-related paraneoplastic syndromes
• Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study)
• Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed.
• Grade 2 peripheral neuropathy (motor or sensory)
• Known HIV or hepatitis B or C infection
• Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies.
• Inadequate hematologic function defined by an absolute neutrophil count <1,500/mm\^3, a platelet count <100,000/mm\^3, or hemoglobin level <9 g/dL.
• Inadequate hepatic function defined by a total bilirubin level >2.0 times the upper limit of normal (ULN), or ≥2.5 times the ULN if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the ULN or ≥5 times the ULN if liver metastases are present.
• Inadequate renal function defined by a serum creatinine level ≥2.5 times the ULN
• Inadequate creatinine clearance defined as less than 50 mL/min.

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Acrc/Arizona Clinical Research Center, Inc. — Tucson, Arizona, United States
• Compassionate Cancer Care Medical Group — Corona, California, United States
• Compassionate Cancer Care Medical Group, Inc. — Fountain Valley, California, United States
• The Angeles Clinic & Research Institute, Inc — Los Angeles, California, United States
• Oncology Care Medical Associates — Montebello, California, United States
• Compassionate Cancer Care Medical Group — Riverside, California, United States
• Sharp Clinical Oncology Research — San Diego, California, United States
• M D Anderson Cancer Center- Orlando — Orlando, Florida, United States
• Georgia Cancer Specialists — Atlanta, Georgia, United States
• University Of Chicago Medical Center — Chicago, Illinois, United States
• Local Institution — Park Ridge, Illinois, United States
• Kentucky Cancer Clinic — Hazard, Kentucky, United States
• The John R. Marsh Cancer Center — Hagerstown, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• The Cancer Center — Minneapolis, Minnesota, United States
• Nevada Cancer Institute — Las Vegas, Nevada, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Local Institution — New York, New York, United States
• Cmc-Northeast/ Northeast Oncology Associates — Concord, North Carolina, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Hematology Oncology Consultants, Inc — Columbus, Ohio, United States
• St. Mary Medical Center — Langhorne, Pennsylvania, United States
• Guthrie Clinical Research — Sayre, Pennsylvania, United States
• Birmingham Hematology & Oncology Assoc. Llc — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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