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Kenneth Kesler
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FP01 - Early Stage/Localized Disease (ID 111)
- Event: WCLC 2020
- Type: Posters (Featured)
- Track: Early Stage/Localized Disease
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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FP01.04 - BTCRC LUN19-396: Adjuvant Chemotherapy Plus Atezolizumab in Stage IB-IIIA Resected NSCLC and Clearance of ctDNA (ID 3164)
00:00 - 00:00 | Author(s): Kenneth Kesler
- Abstract
Introduction
The vast majority of patients with stage IB - IIIA NSCLC are managed with upfront surgery, followed by 4 cycles of empiric adjuvant chemotherapy. However, many patients are cured with surgery alone and do not need any adjuvant therapy. While some patients require adjuvant therapy to achieve cure, the amount of adjuvant therapy necessary to achieve this goal is unknown. In order to optimize treatment, a predictive biomarker is needed to evaluate which patients benefit from adjuvant therapy and to personalize duration of treatment. Emerging data has evaluated the use of circulating tumor DNA (ctDNA) as a promising biomarker for early detection of minimal residual disease to predict risk of relapse. BTCRC LUN19-396 is a multicenter, phase II trial that aims to evaluate the role of concomitant chemotherapy and checkpoint inhibitor in the adjuvant setting for stage IB-IIIA resected NSCLC, and the clearance of ctDNA as a surrogate biomarker for long term disease free survival.
Methods
All patients with stage IB (tumors > 4cm), IIA, IIB, and select IIIA (T3N1, T4N0-1) resected NSCLC will be screened for study entry and will have ctDNA assessed within 60 days after surgery. All patients (regardless of whether they have detectable ctDNA after surgery) will be enrolled and treated with 4 cycles of cisplatin based chemotherapy plus concomitant atezolizumab, followed by up to 13 additional cycles of atezolizumab alone. Sequential analysis of ctDNA will be performed in all patients every 3 months until the end of treatment, up to 17 cycles at 13 months. The trial will enroll a total of 100 patients. The primary objective is to estimate the percentage of patients with detectable ctDNA after surgery who have clearance of ctDNA at designated time points during adjuvant therapy. The key secondary objective is to estimate the 1-year disease free survival in patients with undetectable ctDNA after 4 cycles of adjuvant chemotherapy plus atezolizumab who had detectable ctDNA after surgery. This trial opened to accrual in May 2020. Clinical trial information: NCT04367311
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P03 - Early Stage/Localized Disease - Clinical Trials in Progress (ID 112)
- Event: WCLC 2020
- Type: Posters
- Track: Early Stage/Localized Disease
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P03.01 - A Randomized Phase II Trial of Adjuvant Pembrolizumab vs Observation after Curative Resection for Stage I NSCLC with Primary Tumors Between 1-4 cm (ID 3603)
00:00 - 00:00 | Author(s): Kenneth Kesler
- Abstract
Introduction
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 8th 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 200mg IV every 3 weeks for up to 17 cycles or observation alone with scheduled CT scans and routine clinical follow-up. Stratification factors include PD-L1 TPS ≥50% vs. <50% and tumor size of 1-2cm vs. >2-4cm. The sample size is based on the hypothesis that adjuvant Pembrolizumab will increase 3-year disease free survival (DFS) from 75% to 84.15% (HR=0.6) with a power of 80% and a type I error of 0.1. The lead site is Indiana University, and the trial will be conducted through the Big Ten Cancer Research Consortium. The primary endpoint is 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 2 patients enrolled.
