Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab plus paclitaxel and carboplatin versus placebo plus paclitaxel and carboplatin

Randomized, Multicenter, Double- Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects with Stage IV/Recurrent Non-Small Cell Lung Cancer (NSCLC) with Squamous Histology.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002604-25-HU

Enrollment

1150

Registered

2014-09-09

Start date

2014-10-22

Completion date

Unknown

Last updated

2018-05-28

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

Conditions

LUNG CANCER (NSCLC) MedDRA version: 17.1 Level: LLT Classification code 10025044 Term: Lung cancer System Organ Class: 100000004864 MedDRA version: 17.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864 MedDRA version: 17.1 Level: LLT Classification code 10041071 Term: Small cell lung cancer stage unspecified System Organ Class: 100000004864

Interventions

Product Name: Ipilimumab Product Code: BMS-734016 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: IPILIMUMAB CAS Number: 477202-00-9 Current Sponsor code: BMS-734016 /

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subjects with NSCLC of predominantly squamous histology documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone. - Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer (IASLC) classification) - At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area - Eastern Cooperative Oncology Group (ECOG) performance status = 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 575 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 575

Exclusion criteria

Exclusion criteria: Brain metastases - Malignant pleural effusion that is recurrent - Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of the study is to determine whether ipilimumab plus paclitaxel and carboplatin will extend the life of patients with squamous only non small cell lung cancer more than placebo plus paclitaxel and carboplatin;Secondary Objective: Progression Free Survival Best Overall Response Rate Characterize Safety Profile;Primary end point(s): Overall Survival;Timepoint(s) of evaluation of this end point: 644 Death Events	—

Measure

Time frame

Main Objective: The purpose of the study is to determine whether ipilimumab plus paclitaxel and carboplatin will extend the life of patients with squamous only non small cell lung cancer more than placebo plus paclitaxel and carboplatin;Secondary Objective: Progression Free Survival Best Overall Response Rate Characterize Safety Profile;Primary end point(s): Overall Survival;Timepoint(s) of evaluation of this end point: 644 Death Events

—

Secondary

Measure	Time frame
Secondary end point(s): Progression Free Survival Best Overall Response Rate Characterize Safety Profile;Timepoint(s) of evaluation of this end point: Approximately 45 months post study start	—

Countries

China, Germany, Hungary, Korea, Republic of, Poland, Singapore

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

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