Abstract
A randomized phase II trial of adjuvant pembrolizumab versus observation following curative resection for stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm: Big Ten Cancer Research Consortium BTCRC-LUN18-153
Journal of clinical oncology, Vol.39(15_suppl), pp.TPS8583-TPS8583
05/20/2021
DOI: 10.1200/JCO.2021.39.15_suppl.TPS8583
Abstract
TPS8583
Background: There are approximately 35,000 cases of stage I lung cancer in the United States each year. While these patients have better 5-year overall survival (OS) rates than their counterparts with locally advanced and metastatic disease, there is still considerable room for improvement. Based on a recent publication validating the 8
th
edition of the TNM classification, the 5-year OS for node-negative pathologically-staged NSCLC between 1-4cm ranges from 73-86%, and recurrence rates for resected stage I NSCLC can range from 18-38%. Previous studies looking at adjuvant chemotherapy in this setting have shown no benefit for stage IA tumors, and the current standard of care is observation alone. Checkpoint blockade with PD-1/PD-L1 inhibitors has shown considerable activity in NSCLC including in metastatic disease, as consolidation in stage III disease after chemoradiation, and in studies evaluating neoadjuvant immunotherapy. Given this activity and their favorable safety profile, we designed a study of adjuvant PD-1 inhibition following resection in stage I NSCLC. Methods: This study is a randomized phase II multicenter trial of adjuvant Pembrolizumab versus observation alone following complete resection of stage I NSCLC with tumors between 1-4cm. The trial will enroll 368 patients randomized 1:1 to either Pembrolizumab 400mg IV every 6 weeks for up to 9 cycles or observation alone with scheduled CT scans and routine clinical follow-up. Stratification factors include PD-L1 ≥50% vs. < 50% and tumor size of 1-2cm vs. > 2-4cm. The lead site is Indiana University, and the trial will be conducted through the Big Ten Cancer Research Consortium. The primary endpoint is disease free survival (DFS), and secondary endpoints include OS, DFS at 1-, 2-, and 3-year time points, and toxicity. The trial opened to accrual at the lead site in May 2020, and there are currently 6 patients enrolled. Clinical trial information: NCT04317534.
Details
- Title: Subtitle
- A randomized phase II trial of adjuvant pembrolizumab versus observation following curative resection for stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm: Big Ten Cancer Research Consortium BTCRC-LUN18-153
- Creators
- Greg Andrew Durm - Indiana UniversityMuhammad Furqan - University of IowaLawrence Eric Feldman - University of Illinois Hospital & Health Sciences SystemMalini Patel - Rutgers Cancer Institute of New Jersey, New Bruswick, NJ;Richard Delmar Hall - University of VirginiaShadia Ibrahim Jalal - Indiana UniversityThomas J. Birdas - Indiana UniversityKenneth Kesler - Indiana UniversityKaren Marie Rieger - Indiana UniversityDuyKhanh Ceppa - Indiana UniversityNasser H. Hanna - Indiana University
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.39(15_suppl), pp.TPS8583-TPS8583
- DOI
- 10.1200/JCO.2021.39.15_suppl.TPS8583
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Grant note
- name: Merck
- Language
- English
- Date published
- 05/20/2021
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984362348002771
Metrics
13 Record Views