Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA/N2 Non-small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
To investigate the efficacy and safety of neoadjuvant treatment with Tislelizumab combined with chemotherapy for initially unresectable N2/III non-small cell lung cancer.
Eligibility criteria
Qualifiers
Patients with initially untreated, unresectable stage III NSCLC (according to the International Association for the Study of Lung Cancer IASLC 8th Thoracic Tumor Stage) with non-small cell lung cancer
All patients received baseline PET/CT (or neck, upper thoracic and abdominal CT+ cranial MR) for clinical staging
Cytology/histology (mediastinoscopy or EBUS, etc.) confirmed N2 non-small cell lung cancer
For non-squamous cell carcinoma patients, if EGFR/ALK mutation status is unknown, tissue samples should be provided for EGFR/ALK gene testing before enrollment; For patients with squamous cell carcinoma, if EGFR/ALK mutation status is unknown, testing is not required during screening
Disqualifiers
The patient presents with a confirmed or suspected autoimmune disorder.
Note: Patients with vitiligo, type I diabetes mellitus, or Hashimoto's thyroiditis who are hypothyroid but require only hormone replacement therapy may be included in the study if there are no obvious signs of relapse
Patients must have undergone systemic corticosteroid treatment (≥10mg prednisolone [or equivalent]/day) or received other immunosuppressive medications within 14 days prior to enrollment.
Note: Inhaled or topical corticosteroids and adrenal hormone replacement therapy (≥10mg prednisolone [or equivalent]/day) can also be accepted for individuals lacking clear evidence of autoimmune disorders
Trial design
Treatments tested in this trial
- Tislelizumab Combined With Chemotherapy
Treatment groups
48 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov