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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2007/091/000039
Enrollment
Unknown
Registered
2008-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: ipilimumab, paclitaxel, carboplatin: Intervention2: A:EXPERIMENTAL: Drug: Ipilimumab and Taxol and Paraplatin (concurrent) Intravenous Solution, Intravenous, Ipilimumab - 10mg/kg (4 ac

Sponsors

The pharmaceutical company sponsoring this study is Bristol-Myers Squibb
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Documented NSCLC or SCLC ECOG of 0 or 1

Exclusion criteria

Exclusion criteria: �� Brain metastases �� Autoimmune disease �� Known HIV, Hep B or Hep C infection �� Peripheral neuropathy ≥ grade 2

Design outcomes

Primary

MeasureTime frame
Primary Outcome Measures: EORTC-QLQ-30 questionnaire [ Time Frame: completed at every visit ]Timepoint: [ Time Frame: completed at every visit ]—

Secondary

MeasureTime frame
Safety evaluations in all study armsTimepoint: At defined timepoints per the protocol—

Countries

India

Contacts

Public ContactDr Manishkumar D

Medical Director

manish.mistry@bms.com+912266534208

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026