Non-Small Cell Lung Cancer
Conditions
Interventions
Test Group: Tislelizumab + platinum-based chemotherapy + local treatment (surgery combined with radiotherapy or radiotherapy alone)
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: 18 years or older (inclusive). 2. Informed Consent: Participants must voluntarily agree to participate and provide written informed consent. 3. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration in the 2 weeks prior to treatment initiation, and an expected survival of at least 12 weeks. 4. Histological/Cytological Confirmation: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), staged as T1-4N3M0 (AJCC 9th edition). Lymph nodes suspicious on whole-body 18F-fluorodeoxyglucose positron emission tomography (PET) or contrast-enhanced computed tomography (CT) or PET-CT should undergo invasive lymph node staging via endobronchial ultrasound, mediastinoscopy, thoracoscopy, or needle biopsy. However, invasive staging is not mandatory for highly suspicious mediastinal lymph nodes in zones 5 and 6. 5. Biomarker Testing: For non-squamous NSCLC patients, EGFR, ALK, and other relevant biomarker test results based on tumor tissue or blood samples must be provided. For squamous NSCLC patients, if the status of sensitive gene mutations is unknown, biomarker testing is not required at screening. 6. Treatment Naïve: No prior systemic or local therapy for NSCLC after diagnosis. 7. Measurable Lesion: At least one measurable lesion according to RECIST 1.1 criteria at baseline. The longest diameter should be >=10 mm (or short axis >=15 mm for lymph nodes). The chosen method of measurement should allow for accurate repeat measurements, which can be performed by computed tomography (CT) or magnetic resonance imaging (MRI). If only one measurable lesion exists, it can be considered as a target lesion, provided that baseline evaluation occurs at least 14 days after diagnostic biopsy. Baseline radiographic assessment should be performed within 28 days prior to the first dose of study treatment. 8. Contraception for Women of Childbearing Potential: Women of childbearing potential must use effective contraception from screening until 6 months after discontinuation of study treatment and should not breastfeed. A negative pregnancy test is required before starting treatment, or one of the following criteria must be met to confirm the absence of pregnancy risk: (1) Postmenopausal, defined as age greater than 50 years and amenorrhea for more than 12 months following cessation of all exogenous hormonal replacement therapy. (2) For women under 50 years old, if amenorrhea has occurred for 12 months or more after cessation of all exogenous hormonal therapy, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory's postmenopausal reference range, they are also considered postmenopausal. (3) History of irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy (but not bilateral tubal ligation). 9. Contraception for Men: Non-sterilized males must use barrier contraception (i.e., condoms) from screening until 6 months after discontinuation of study treatment. Sterilized males are defined as: (1) Males who have had azoospermia confirmed by semen sample analysis prior to the study, which is definitive evidence of male sterilization. (2) In this study, males with known "low sperm count" (consistent with the definition of "subfertility") are still considered fertile and not sterile.
Exclusion criteria
Exclusion criteria: Participants will be excluded from this study if they meet any of the following criteria: 1. Diagnosis of Pancoast Tumor. 2. Pathology: Large cell neuroendocrine carcinoma (LCNEC). 3. Tumor Infiltration: Primary tumor or metastatic lymph nodes infiltrating major vessels such as the aorta, trachea, esophagus, or heart. 4. Previous Treatments: (1) Prior lung surgery. (2) Any prior systemic chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatment for lung cancer. (3) Known presence of sensitive mutations such as EGFR mutations, ALK rearrangements, ROS1 rearrangements, BRAF V600 mutations, RET rearrangements, MET exon 14 skipping mutations, NTRK1/2/3 rearrangements, etc. (4) Prior radiotherapy to the lungs. (5) Major surgery within 14 days prior to the first dose of study treatment, or within 28 days if not fully recovered from toxicity and/or complications of intervention. (6) Use of traditional Chinese medicine with anti-tumor effects must have been discontinued for at least 2 weeks before starting the study drug and should not exceed 7 days of use. 5. Other Malignancies: Diagnosed with another malignancy within 5 years prior to screening (exceptions include completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast). 6. Autoimmune Diseases: Active autoimmune disease or history of autoimmune disease that may recur (exceptions include patients with well-controlled Type 1 diabetes, hypothyroidism managed by hormone replacement, well-controlled celiac disease, non-systemic dermatological conditions like vitiligo, psoriasis, alopecia, or any other condition expected not to recur without external triggers). 7. Corticosteroid Use: Conditions requiring systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study treatment (exceptions include adrenal replacement steroids, minimal systemic absorption of local/topical/inhaled corticosteroids, short-term use for prophylaxis or non-autoimmune conditions). 8. Uncontrolled Diabetes: Uncontrolled diabetes or laboratory abnormalities > Grade 1 (potassium, sodium, corrected calcium) despite standard medical management within 14 days prior to the first dose of study treatment. 9. Effusions: Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks post-intervention). 10. Interstitial Lung Disease: History of interstitial lung disease, clinically active interstitial lung disease, pulmonary inflammation (non-infectious), or poorly controlled pulmonary conditions (e.g., pulmonary fibrosis, acute interstitial lung disease). 11. Infections: Fever >=38°C within 7 days prior to the first dose, significant active infections, active tuberculosis, or active fungal, bacterial, or viral infections requiring systemic treatment (chronic HBV or HCV infection patients receiving antiviral treatment are allowed). 12. Hepatitis B: Untreated chronic hepatitis B or chronic HBV carriers with HBV DNA > 500 IU/mL (or > 2500 copies/mL). Inactive HBsAg carriers or treated stable hepatitis B patients (HBV DNA < 500 IU/mL or < 2500 copies/mL) can be included. Patients with detectable HBsAg or HBV DNA should be managed according to guidelines. 13. Hepatitis C: Active hepatitis C virus (HCV) infection (patients with negative HCV antibodies or positive antibodies but negative HCV RNA can be i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year event-free survival rate, 1y-EFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| event-free survival, EFS;overall survival, OS;R0 rate;time to distant metastasis, TTDM;time to locoregional recurrence, TTLR;Local recurrence rate;Distant metastasis rate;Safety;Quality of life;Patient-reported outcomes; | — |
Countries
China
Contacts
Public ContactHongxu Liu
Liaoning Cancer Hospital & Institute
Outcome results
None listed