Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
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| ClinicalTrials.gov Identifier: NCT01450761 |
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Recruitment Status :
Completed
First Posted : October 12, 2011
Results First Posted : July 18, 2016
Last Update Posted : July 8, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Small Cell Lung Carcinoma | Biological: Ipilimumab Biological: Placebo matching Ipilimumab Drug: Etoposide Drug: Cisplatin Drug: Carboplatin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1351 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) |
| Actual Study Start Date : | December 13, 2011 |
| Actual Primary Completion Date : | March 19, 2015 |
| Actual Study Completion Date : | May 17, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ipilimumab+Etoposide+Cisplatin/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 |
Biological: Ipilimumab
Other Names:
Drug: Etoposide Other Names:
Drug: Cisplatin Other Name: Platinol Drug: Carboplatin Other Name: Paraplatin |
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Placebo Comparator: Placebo matching Ipilimumab+Etoposide+Cisplatin/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 |
Biological: Placebo matching Ipilimumab Drug: Etoposide Other Names:
Drug: Cisplatin Other Name: Platinol Drug: Carboplatin Other Name: Paraplatin |
- Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy [ Time Frame: 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.
- Overall Survival in All Randomized Participants [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450761
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01450761 |
| Other Study ID Numbers: |
CA184-156 2011-000850-48 ( EudraCT Number ) |
| First Posted: | October 12, 2011 Key Record Dates |
| Results First Posted: | July 18, 2016 |
| Last Update Posted: | July 8, 2020 |
| Last Verified: | July 2020 |
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Small Cell Lung Carcinoma Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Cisplatin |
Carboplatin Etoposide Ipilimumab Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors |