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

NCT ID: NCT00527735

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-12-31

Brief Summary

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.

Conditions

Lung Cancer; Small Cell Lung Cancer; Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent)

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.

Placebo

Intervention Type: DRUG

Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.

Paclitaxel

Intervention Type: DRUG

175 mg/m\^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.

Carboplatin

Intervention Type: DRUG

Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.

Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.

Placebo

Intervention Type: DRUG

Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.

Paclitaxel

Intervention Type: DRUG

175 mg/m\^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.

Carboplatin

Intervention Type: DRUG

Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.

Ipilimumab placebo + paclitaxel + carboplatin

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.

Paclitaxel

Intervention Type: DRUG

175 mg/m\^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.

Carboplatin

Intervention Type: DRUG

Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.

Interventions

Ipilimumab

Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.

Intervention Type: DRUG

Placebo

Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.

Intervention Type: DRUG

Paclitaxel

175 mg/m\^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.

Intervention Type: DRUG

Carboplatin

Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Birmingham Hematology & Oncology Assoc. Llc

Birmingham, Alabama, United States

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

Santee Hematology/Oncology

Sumter, South Carolina, United States

Southwest Cancer Treatment And Research Center

Lubbock, Texas, United States

Local Institution

Belfort, , France

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Caen, , France

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Marseille, , France

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Rennes, , France

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Bochum, , Germany

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Cologne, , Germany

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Coswig, , Germany

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Ebensfeld, , Germany

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Großhansdorf, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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München, , Germany

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Hyderabad, Andhra Pradesh, India

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Navrangpura, Ahmedabad, Gujarat, India

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Manipal, Karnataka, India

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Trivandrum, Kerala, India

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Vellore, , India

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Genova, , Italy

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Siena, , Italy

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Torino, , Italy

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Gdansk, , Poland

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Krakow, , Poland

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Olsztyn, , Poland

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Szczecin, , Poland

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Arkhangelsk, , Russia

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Chelyabinsk, , Russia

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Ivanovo, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Pyatigorsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Sochi, , Russia

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Lviv, , Ukraine

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Ternopil, , Ukraine

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Uzhhorod, , Ukraine

Countries

United States; France; Germany; India; Italy; Poland; Russia; Ukraine

Other Identifiers

CA184-041

Identifier Type: -

Identifier Source: org_study_id