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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patient with age ≥ 18 years old, gender is not limited.

• Histologically confirmed primary NSCLC, postoperative stage is IIA, IIB, IIIA or T3N2IIIB.

• Receiving complete resection

• Paraffin-embedded sections (10-15 pieces) or fresh frozen tissue are required.

• ECOG score of 0 or 1.

• Females of childbearing age should take appropriate contraceptive measures from screening to 3 months after discontinuation of study treatment and should not breastfeed. The pregnancy test was negative before starting dosing.

• Male patients should use barrier contraception from screening to 3 months after discontinuation of study treatment.

• The subjects themselves participated voluntarily and signed the informed consent in writing.

Locations
Other Locations
China
The First Affiliated Hospital of Zhengzhou University,
RECRUITING
Zhengzhou
Contact Information
Primary
Feng Li, MD
LF_0604@163.com
+8615838222689
Backup
Yu Qi
qiyu@zzu.edu.cn
+8613803892392
Time Frame
Start Date: 2022-06-20
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 60
Treatments
Experimental: MRD-guided adjuvant tislelizumab and chemotherapy
MRD+: Tislelizumab 200mg Q3W + chemotherapy 1-4 cycles and followed by Tislelizumab 200mg Q3W Up to 16 cycles or until PD or intolerable toxicity or withdrawal~MRD-: Adjuvant chemotherapy and surveillance the MRD status, the patient will receive treatment for MRD+ patient when MRD detected,
Active_comparator: Non MRD-guided adjuvant tislelizumab and chemotherapy
patients in non MRD-guided arm receive adjuvant tislelizumab and chemotherapy
Related Therapeutic Areas
Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)
Sponsors
Collaborators: BeiGene
Leads: The First Affiliated Hospital of Zhengzhou University

This content was sourced from clinicaltrials.gov

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