Using MRD-guided treatment with tislelizumab and chemotherapy for resected 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)

This study is testing if a personalized treatment plan using a new drug and chemotherapy can help patients with early-stage non-small cell lung cancer do better after surgery compared to standard treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Zhengzhou University (Academic / other)
• Drugs / interventions: tislelizumab, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT05286957 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the efficacy and safety of minimal residual disease (MRD)-guided adjuvant therapy using tislelizumab and chemotherapy compared to standard adjuvant therapy in patients with resectable non-small cell lung cancer (NSCLC). Patients with confirmed stage IIA to IIIB NSCLC who have undergone complete surgical resection will be enrolled. The study aims to determine if tailoring treatment based on MRD status improves outcomes for patients. Participants will receive either MRD-guided or standard treatment regimens.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed stage IIA to IIIB NSCLC who have undergone complete resection.

Not a fit: Patients who have previously received immune checkpoint inhibitors or other immunotherapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with resectable NSCLC.

How similar studies have performed: Other studies have shown promise with MRD-guided approaches in various cancers, suggesting potential for success in this novel application.

Eligibility criteria

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:

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.

Where this trial is running

Zhengzhou, Henan

• The First Affiliated Hospital of Zhengzhou University, — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Yu Qi — The First Affiliated Hospital of Zhengzhou University
• Study coordinator: Feng Li, MD

Conditions NSCLC; ctDNA-MRD