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

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.

Timeline

Start

2011-12-13

Primary completion

2015-03-19

Completion

2017-05-17

Outcome

Missed primary endpoint

paper Median OS was 11.0 months for chemotherapy plus ipilimumab versus 10.9 months for chemotherapy plus placebo (hazard ratio, 0.94; 95% CI, 0.81 to 1.09; P = .3775). PMID 27458307 ↗

paper Conclusion Addition of ipilimumab to chemotherapy did not prolong OS versus chemotherapy alone in patients with newly diagnosed extensive-stage disease SCLC. PMID 27458307 ↗

Publications

• Reck M, Luft A, Szczesna A, Havel L, Kim SW, Akerley W, Pietanza MC, Wu YL, Zielinski C, Thomas M, Felip E, Gold K, Horn L, Aerts J, Nakagawa K, Lorigan P, Pieters A, Kong Sanchez T, Fairchild J, Spigel D. Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2016 Nov 1;34(31):3740-3748. doi: 10.1200/JCO.2016.67.6601.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	10 mg/kg	Intravenous
Background	Carboplatin	Small molecule	5 unknown	—
Background	Cisplatin	Other / unclassified	75 mg/m2	—
Background	Etoposide	Small molecule	100 mg/m2	—

Indications