STUDY DESIGN
IMpower133: A PIVOTAL TRIAL ASSESSING THE EFFICACY AND SAFETY OF TECENTRIQ + CARBO + ETOP IN COMBINATION FOR 1L ES-SCLC1
A phase I (safety) and phase III (efficacy), randomized, multicentre, double-blind, placebo-controlled study in chemotherapy-naïve ES-SCLC patients2
Exclusion criteria
This study excluded patients who had active or untreated CNS metastases; history of autoimmune disease; administration of a live, attenuated vaccine within 4 weeks prior to randomization; or administration of systemic immunosuppressive medications within 1 week prior to randomization. Thoracic radiation with curative intent was not permitted. Randomization was stratified by sex, ECOG performance status and presence of brain metastases.
* Carboplatin and etoposide were administered until completion of 4 cycles, or progressive disease or unacceptable toxicity, whichever occurred first.
† As assessed by investigator.
AUC=area under the concentration-time curve; CNS=central nervous system; ECOG=Eastern Cooperative Oncology Group; q6w=every 6 weeks; q9w=every 9 weeks.
References: 1. Hann C, Scherpereel A, Hellyer J, et al. Role of immunotherapy in small cell lung cancer, thymic epithelial tumors, and mesothelioma. American Society of Clinical Oncology Educational Book. 39 (May 17, 2019):543-552. 2. TECENTRIQ Product Monograph. Hoffmann-La Roche Limited. January 21, 2020. 3. Horn L, Mansfield AS, Szczęsna A, et al. First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer [published online September 25, 2018]. N Engl J Med. doi:10.1056/NEJMoa1809064.
IMpower133: A PIVOTAL TRIAL ASSESSING THE EFFICACY AND SAFETY OF TECENTRIQ + CARBO + ETOP IN COMBINATION FOR 1L ES-SCLC1
A phase I (safety) and phase III (efficacy), randomized, multicentre, double-blind, placebo-controlled study in chemotherapy-naïve ES-SCLC patients2
| Co-primary endpoints2 | Key secondary endpoints2 |
• Overall survival (OS) |
• Objective response rate (ORR), investigator-assessed per RECIST v1.1 • Duration of response (DOR), investigator-assessed per RECIST v1.1 |