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RECRUITING
NCT05286957
PHASE2

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

Sponsor: The First Affiliated Hospital of Zhengzhou University

View on ClinicalTrials.gov

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

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2022-06-20

Completion Date

2027-06-01

Last Updated

2023-03-17

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

The First Affiliated Hospital of Zhengzhou University,

Zhengzhou, Henan, China