NCT05286957

MRD-guided Adjuvant Tislelizumab and Chemotherapy in Resected Stage IIA-IIIB NSCLC

Minimal Residual Disease (MRD)-Guided Adjuvant Tislelizumab and Chemotherapy in Resected Stage IIA-IIIB Non-small Cell Lung Cancer (NSCLC): a Randomized Controlled Phase II Study (Seagull)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Seagull is a phase Ⅱ study designed to investigate the efficacy and safety of MRD-guided adjuvant tislelizumab and chemotherapy vs adjuvant tislelizumab and chemotherapy in patients with resectable NSCLC

Detailed description

In the phase II trial, the efficacy and safety of MRD-guided adjuvant tislelizumab and chemotherapy will be compared with that of standard adjuvant tislelizumab and chemotherapy in patients with resectable NSCLC.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	adjuvant tislelizumab and chemotherapy for MRD+ patients	MRD+ patients receive adjuvant tislelizumab and chemotherapy while MRD- patients just is recommended receive adjuvant chemotherapy untill be detected MRD+ adjuvant tislelizumab and chemotherapy (cisplatin/carboplatin + paclitaxel or cisplatin/carboplatin + pemetrexed,dependent on tumor histology and at investigator's discretion)
DRUG	adjuvant tislelizumab and chemotherapy for MRD+ patients	patients receive adjuvant tislelizumab and chemotherapy regardless of MRD status
DRUG	adjuvant chemotherapy for MRD- patients	MRD- patients just be recommended receive adjuvant chemotherapy untill be detected cisplatin/carboplatin + paclitaxel or cisplatin/carboplatin + pemetrexed,dependent on tumor histology and at investigator's discretion, limited to ≤4 cycles

Timeline

• Start date: 2022-06-20
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2022-03-18
• Last updated: 2023-03-17

Locations

1 site across 1 country: China