Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
Condition: Lung Cancer; Small Cell Lung Cancer; Carcinoma, Non-Small-Cell Lung
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung
Intervention: Ipilimumab; Placebo; Paclitaxel; Carboplatin
Intervention description: 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.; 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.; 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.; 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 MeSH terms: Paclitaxel; Carboplatin; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 334.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non Small Cell Lung Cancer (NSCLC); Small Cell Lung Cancer (SCLC)

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.
    

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.