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NCT05286957RecruitingPhase 2

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)

Source: ClinicalTrials.gov · Last updated 17 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
1 Mar 2022
Start date
20 Jun 2022
Primary completion date
1 Jun 2026
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Diseases
Lung cancer
NCT number
NCT05286957

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 20 Jun 2022 to the primary completion date, 1 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).
  • 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.

Other illness

  • 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.
  • History of ILD, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease
  • 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.
  • Patients who, in the investigator's judgment, have any condition that compromises patient safety or interferes with the evaluation of the study.

Lab values

  • Harboring EGFR sensitizing mutation or ALK gene translocation

Age

  • 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.

Other

  • Histopathology with small cell or large cell endocrine tumor component.
  • Insufficient bone marrow reserve or organ function.
  • Patients who, in the judgment of the investigator, may not comply with the procedures and requirements of the study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Zhengzhou University
Coordinator of this site? Confirm its status
ZhengzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.