Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin

Phase 3

Completed

• Conditions: Lung Cancer (NSCLC)
• Interventions: Biological: Paclitaxel; Biological: Carboplatin; Biological: Ipilimumab; Other: Placebo

• Registration Number: NCT02279732
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-13
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-31
• Primary Completion: 2018-05-03
• Study Completion: 2018-05-03
• Results First Submitted: 2019-05-01
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-22
• Last Update Submitted: 2019-07-22
• Results First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Carboplatin + Paclitaxel + Ipilimumab	Carboplatin	Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by modified WHO (mWHO) Carboplatin Area Under the Curve (AUC6) IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Ipilimumab 10 mg/kg IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Arm 2: Carboplatin + Paclitaxel + Placebo	Paclitaxel	Carboplatin AUC6 IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Placebo IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Arm 1: Carboplatin + Paclitaxel + Ipilimumab	Paclitaxel	Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by modified WHO (mWHO) Carboplatin Area Under the Curve (AUC6) IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Ipilimumab 10 mg/kg IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Arm 2: Carboplatin + Paclitaxel + Placebo	Carboplatin	Carboplatin AUC6 IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Placebo IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Arm 1: Carboplatin + Paclitaxel + Ipilimumab	Ipilimumab	Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by modified WHO (mWHO) Carboplatin Area Under the Curve (AUC6) IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Ipilimumab 10 mg/kg IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Arm 2: Carboplatin + Paclitaxel + Placebo	Placebo	Carboplatin AUC6 IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Placebo IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy	Approximately 43 months post study start	OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.

Secondary Outcome Measures

Name	Time	Method
Overall Survival of All Randomized Participants	Approximately 43 months post study start	OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
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	Approximately 43 months post study start	PFS is defined as the time between the date of randomization and the date of progression per mWHO criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria was considered to have progressed on the date of death. For those participants who remained alive and had not progressed, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.

Trial Locations

Locations (7)

Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza; 🇭🇺 Deszk, Hungary

Klinika Nowotworow Pluca i Klatki Piersiowej; 🇵🇱 Warszawa, Poland

Oddzial Chemioterapii; 🇵🇱 Poznan, Poland

Pulmonologiai Klinika; 🇭🇺 Budapest, Hungary

Oddzial Onkologiczny; 🇵🇱 Elblag, Poland

Torokbalinti Tudogyogyintezet; 🇭🇺 Torokbalint, Hungary

Local Institution; 🇸🇬 Singapore, Singapore