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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

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

Treatments: Drug: Ipilimumab; Drug: Paclitaxel; Drug: Carboplatin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00527735

CA184-041

Details and patient eligibility

About

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.

Enrollment: 334 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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334 participants in 3 patient groups

Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent)

Experimental group

Treatment:

Drug: Ipilimumab

Drug: Carboplatin

Drug: Placebo

Drug: Paclitaxel

Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)

Experimental group

Treatment:

Drug: Ipilimumab

Drug: Carboplatin

Drug: Placebo

Drug: Paclitaxel

Ipilimumab placebo + paclitaxel + carboplatin

Active Comparator group

Treatment:

Drug: Carboplatin

Drug: Placebo

Drug: Paclitaxel