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Journal Title: RESILIENT part II: An open-label, randomized, phase III study of liposomal irinotecan injection in patients with small-cell lung cancer who have progressed with platinum-based first-line therapy
2020 Annual Meeting of the American Society of Clinical Oncology, ASCO 2020. Chicago, IL United States.
Authors: Spigel, David R.
Paz-Ares, Luis G.
Moore, Yan
Zhang, Bin
Dowlati, Afshin
Navarro, Alejandro
Caro, Reyes Bernabe
Calderon, Vanesa Gutierrez
Hayes, Theresa M.
Rich, Patricia
Juan-Vidal, Oscar
Jove, Maria
Chen, Yuanbin
Bunn, Paul
Aix, Santiago Ponce
Kokhreidze, Jaba
Wang, Haofei Tiffany
SWH Author: Hayes, Theresa M.
Keywords: Drug Therapy
Drug Safety
Drug Withdrawal
Drug Tolerability
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Follow Up
Clinical Study
Overall Survival
Open Study
Phase 2 Clinical Trial
Preliminary Data
Phase 3 Clinical Trial
Randomized Controlled Trial
Progression Free Survival
Response Evaluation Criteria in Solid Tumors
Sample Size
Risk Assessment
Small Cell Lung Cancer
Cancer Patient
Antineoplastic Activity
Central Nervous System
Cancer Survival
Comparative Effectiveness
Clinical Trial
Controlled Study
Conference Abstract
Drug Efficacy
Issue Date: 2020
Date Accessioned: 2023-04-12T02:09:55Z
Date Available: 2023-04-12T02:09:55Z
Source Volume: 38
Issue Number: 15
Database: Embase
Date: 2020
Abstract: Background: Although small cell lung cancer (SCLC) is often sensitive to established first-line therapies, many patients relapse and develop drug resistance, and second-line therapies are limited. RESILIENT (NCT03088813) is a two-part phase 2/3 study assessing the safety, tolerability, and efficacy of liposomal irinotecan monotherapy in patients with SCLC who progressed with platinum-based first-line therapy. Preliminary data from the dose-ranging part of the study (part 1) showed that liposomal irinotecan 70 mg/m2administered every 2 weeks was well tolerated and had promising antitumor activity (Paz- Ares et al. ASCO 2019; poster 318). Here, we present the design of the second, larger part of the study, which will evaluate the efficacy and safety of liposomal irinotecan versus topotecan in the same patient population. Method(s): Part 2 of RESILIENT is a phase 3, open-label study with a planned sample size of 450. Patients are randomly allocated 1:1 to intravenous liposomal irinotecan or intravenous topotecan. Liposomal irinotecan is administered every 2 weeks at 70 mg/m2(free-base equivalent) and topotecan is administered for 5 consecutive days every 3 weeks at 1.5 mg/m2. As of January 2020, 80 patients have been enrolled in part 2 of the trial. Tumor assessments are performed using the Response Evaluation Criteria in Solid Tumors version 1.1 and the Response Assessment in Neurooncology criteria for CNS lesions; symptom improvement is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Safety assessments include monitoring for adverse events. The primary endpoint is overall survival (OS) and secondary endpoints are progression-free survival (PFS), objective response rate, and proportion of patients reporting symptom improvement. Patients will continue study treatment until disease progression, unacceptable toxicity or study withdrawal and will then be followed for survival until death or study end (when all patients have died, withdrawn consent or are lost to follow-up).
Journal Title: Journal of Clinical Oncology
Type: Conference Paper
Conference Name: 2020 Annual Meeting of the American Society of Clinical Oncology, ASCO 2020.
Conference Location: Chicago, IL United States.
Appears in Collections:SWH Staff Publications

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