Phase 3
N=204
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin
Lung Cancer (NSCLC)
Bottom Line
View on ClinicalTrials.gov: NCT02279732 ↗Enrolled (actual)
204
Serious AEs
35.8%
Results posted
Aug 2019
Primary outcome: Primary: Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy — NA; NA months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Paclitaxel (Biological); Carboplatin (Biological); Ipilimumab (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy |
NA; NA | — |
| SECONDARY Overall Survival of All Randomized Participants |
NA; NA | — |
| SECONDARY Progression-free Survival (PFS) Among All Randomized Particiapants Who Received at Least One Dose of Blinded Study Therapy Using Modified World Health Organization (mWHO) Criteria |
NA; NA | — |
Summary
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.
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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
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
Data sourced from ClinicalTrials.gov (NCT02279732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.