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A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer, Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung

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Trial Information

A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)

Outcome Description:

irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.

Outcome Time Frame:

Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

December 2011

Related Keywords:

  • Lung Cancer
  • Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Non Small Cell Lung Cancer (NSCLC)
  • Small Cell Lung Cancer (SCLC)
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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