Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

Phase 3

Completed

• Conditions: Small Cell Lung Carcinoma
• Interventions: Biological: Placebo matching Ipilimumab; Biological: Ipilimumab; Drug: Etoposide; Drug: Cisplatin; Drug: Carboplatin

• Registration Number: NCT01450761
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-12
• Study Start: 2011-12-13
• Primary Completion: 2015-03-19
• Results First Submitted: 2016-03-07
• Results First Submitted QC: 2016-06-07
• Results First Posted: 2016-07-18
• Study Completion: 2017-05-17
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-06
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1351

Inclusion Criteria

• Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
• Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion Criteria

• Prior systemic therapy for lung cancer
• Symptomatic Central Nervous System (CNS) metastases
• History of autoimmune disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin	Placebo matching Ipilimumab	Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Ipilimumab+Etoposide+Cisplatin/Carboplatin	Cisplatin	Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Ipilimumab+Etoposide+Cisplatin/Carboplatin	Ipilimumab	Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Ipilimumab+Etoposide+Cisplatin/Carboplatin	Etoposide	Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Ipilimumab+Etoposide+Cisplatin/Carboplatin	Carboplatin	Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin	Etoposide	Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin	Carboplatin	Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin	Cisplatin	Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy	Randomization until date of death, up to March 2015, approximately 38 months	Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.

Secondary Outcome Measures

Name	Time	Method
Overall Survival in All Randomized Participants	From randomization until date of death, up to March 2015, approximately 38 months	Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy	From randomization until disease progression, up to March 2015, approximately 38 months	Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, 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 (43)

Genesis Cancer Center; 🇺🇸 Hot Springs, Arkansas, United States

Sutter Medical Center; 🇺🇸 Auburn, California, United States

UCSD Moores Cancer Center; 🇺🇸 La Jolla, California, United States

University Of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

Florida Cancer Specialists S.; 🇺🇸 Fort Myers, Florida, United States

Cancer Specialists, LLC; 🇺🇸 Jacksonville, Florida, United States

Lake City Cancer Care; 🇺🇸 Lake City, Florida, United States

Florida Cancer Specialists; 🇺🇸 Saint Petersburg, Florida, United States

Medical Oncology, LLC; 🇺🇸 Augusta, Georgia, United States

Quincy Medical Group; 🇺🇸 Quincy, Illinois, United States

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