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RecruitingNCT05286957SeagullUpdated Mar 17, 2023

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

A Phase 2 interventional study of adjuvant tislelizumab and chemotherapy for MRD+ patients and adjuvant tislelizumab and chemotherapy for MRD+ patients in NSCLC, sponsored by The First Affiliated Hospital of Zhengzhou University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-17.

Sponsored by The First Affiliated Hospital of Zhengzhou University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jun 2022; still recruiting 4 years 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • NSCLC

Keywords

  • ctDNA-MRD
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 60 is close to the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 123 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient with age ≥ 18 years old, gender is not limited.
  2. Histologically confirmed primary NSCLC, postoperative stage is IIA, IIB, IIIA or T3N2IIIB.
  3. Receiving complete resection
  4. Paraffin-embedded sections (10-15 pieces) or fresh frozen tissue are required.
  5. ECOG score of 0 or 1.
  6. 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.
  7. Male patients should use barrier contraception from screening to 3 months after discontinuation of study treatment.
  8. The subjects themselves participated voluntarily and signed the informed consent in writing.

Exclusion criteria

Exclusion Criteria:

  1. The patient has received immune checkpoint inhibitors such as anti-PD-1, PD-L1 or CTLA-4, other immunotherapy or systemic immune modulators (including but not limited to interferon, IL-2 and TNF etc).
  2. Histopathology with small cell or large cell endocrine tumor component.
  3. Harboring EGFR sensitizing mutation or ALK gene translocation
  4. History of other malignant tumors, except for non-melanoma skin cancer, carcinoma in situ or other solid tumors that have been effectively treated, and no evidence of any disease for >5 years after the last treatment.
  5. At the start of the study treatment, there are residual toxicities of the previous treatment that are greater than CTCAE 1 and have not been alleviated, except for alopecia and grade 2 neurotoxicity caused by previous chemotherapy.
  6. Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, active bleeding, active infection including hepatitis B, C, HIV, etc., which the investigator considers unsuitable to participate in the study or affect the trial program compliance.
  7. History of ILD, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease
  8. Insufficient bone marrow reserve or organ function.
  9. History of hypersensitivity reactions to any active or inactive ingredient of tislelizumab or to drugs that are chemically similar to tislelizumab or in the same class of tislelizumab.
  10. Patients who, in the judgment of the investigator, may not comply with the procedures and requirements of the study.
  11. Patients who, in the investigator's judgment, have any condition that compromises patient safety or interferes with the evaluation of the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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,

    Drug: adjuvant tislelizumab and chemotherapy for MRD+ patients

  • Active comparator
    Non MRD-guided adjuvant tislelizumab and chemotherapy

    patients in non MRD-guided arm receive adjuvant tislelizumab and chemotherapy

    Drug: adjuvant tislelizumab and chemotherapy for MRD+ patients · Drug: adjuvant chemotherapy for MRD- patients

Interventions

  • Drugadjuvant 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)

  • Drugadjuvant tislelizumab and chemotherapy for MRD+ patients

    patients receive adjuvant tislelizumab and chemotherapy regardless of MRD status

  • Drugadjuvant 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

06

What researchers measure

Primary outcomes

  1. 2-year PFS rate

    Progression-free survival (per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first. Subjects who do not have disease progression will be censored at their last valid tumor assessment. PFS rate at 1 year as estimated by Kaplan-Meier method.

    Time frame: up to 36 months after enrollment or study close

Secondary outcomes

  1. Percentage of patients changed from MRD+ to MRD- after treatment with tislelizumab for 6 months，12 months

    Percentage of patients changed from MRD+ to MRD- after treatment with Tislelizumab for 9 months，12months

    Time frame: At the end of Cycle 8(each cycle is 21 days)、Cycle 16 (each cycle is 21 days)

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Zhengzhou University,
    Zhengzhou, Henan 450052, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05286957
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborators
BeiGene
Responsible party
Qi Yu (chief physician, The First Affiliated Hospital of Zhengzhou University) — Principal investigator
First posted
Mar 18, 2022
Start date
Jun 20, 2022
Primary completion
Jun 1, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Mar 17, 2023

Study contacts

Feng Li, MD
Contact
LF_0604@163.com
+8615838222689
Yu Qi
Contact
qiyu@zzu.edu.cn
+8613803892392
Yu Qi
principal investigator · The First Affiliated Hospital of Zhengzhou University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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