304TiP - Minimal residual disease (MRD)-guided adjuvant tislelizumab after adjuvant chemotherapy in resected stage IIA-IIIB non-small cell lung cancer (NSCLC): A single-arm phase II study (Seagull)

Background

Emerging data have shown the potential for circulating tumor DNA(ctDNA)-based MRD status to predict clinical recurrence in patients(pts) with stage I-III NSCLC. Moreover, research have shown that detection of ctDNA preceded radiographic progression by a median of 5.2 months. IMpower010 have shown a disease-free survival(DFS) benefit with atezolizumab versus best supportive care after adjuvant chemotherapy in patients with resected stage II–IIIA NSCLC. Tislelizumab, an anti-PD-1 mAb, has shown improved efficacy in patients with advanced NSCLC with a tolerable safety profile. The current study explores a follow-up intervention mode for resected stage II/III NSCLC, that is MRD monitoring for recurrence and give earlier intervention to reduce the recurrence rate and improve the survival rate.

Trial design

The Seagull study is a single-arm phase II study enrolls EGFR and ALK double negative pts with completely resected stage IIA to T3N2 ⅢB NSCLC per American Joint Committee on Cancer staging system (8th edition). The ctDNA-based MRD will be assessed after 3 weeks after adjuvant chemotherapy and then every 3 months up to 36 months. Pts with MRD+ will receive treatment with tislelizumab (200mg IV every 3 weeks; for 16 cycles or 1 year). MRD- Pts will be monitored by ctDNA every 3 months to 36 months or until investigator-assessed disease progression. Primary endpoint was percentage of pts changed from MRD+ to MRD- after treatment with 8 cycles (6 months) tislelizumab, and secondary endpoints included percentage of pts changed from MRD+ to MRD- after treatment with tislelizumab for 9 months, 12 months, 1-year DFS rate, 2-year DFS rate, 3-year DFS rate and 3-year OS rate, etc.

Clinical trial identification

NCT05286957.

Legal entity responsible for the study

The First Affiliated Hospital of Zhengzhou University.

Funding

BeiGene.

Disclosure

All authors have declared no conflicts of interest.