OncoMatch/Clinical Trials/NCT06598527
Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy Versus Tislelizumab Plus Platinum-based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage Ⅱ-Ⅲ Non-small Cell Lung Cancer: A Phase Ⅲ, Randomized, Multicenter, Prospective Study
Is NCT06598527 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Tislelizumab and Chemotherapy for lung cancer (nsclc).
Treatment: Tislelizumab · Chemotherapy — The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant Stereotactic Body Radiotherapy (SBRT) combined with immunochemotherapy versus neoadjuvant immunochemotherapy. The main questions it aims to answer are: Dose SBRT combined with immunochemotherapy improve event-free survival? Is SBRT combined with immunochemotherapy safe enough? Participants will: Receive neoadjuvant SBRT combined with immunochemotherapy or neoadjuvant immunochemotherapy. Tumor assessment will be performed prior to surgery. Surgery will be performed within 4 to 6 weeks (+ 7 days) after completion of the last cycle of immunochemotherapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR mutation
EGFR-mutations ... positive NSCLC [excluded]
Required: ALK fusion
ALK-fusion positive NSCLC [excluded]
Disease stage
Required: Stage IIA, IIB, IIIA, IIIB (T3-4N2) (AJCC 8th edition)
untreated stage IIa-IIIa (according to the AJCC 8th edition of thoracic tumor staging) non-small cell lung cancer. In addition, patients with potentially resectable stage IIIb (T3-4N2) NSCLC will also be enrolled.
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-PD-1 therapy
Received prior therapy with an anti-PD-1
Cannot have received: anti-PD-L1 therapy
Received prior therapy with an anti-PD-L1
Cannot have received: anti-PD-L2 therapy
Received prior therapy with an anti-PD-L2
Cannot have received: anti-CTLA-4 therapy
Received prior therapy with an anti-CTLA
Cannot have received: T-cell co-stimulation or immunoregulation pathway inhibitor
any other drugs specifically targeting T-cell co-stimulation or immunoregulation pathways
Cannot have received: radiation therapy
Exception: historical radiotherapy of chest
Historical radiotherapy of chest
Lab requirements
Blood counts
neutrophils ≥ 1500 x 10^9/L; platelets ≥ 100 x 10^9/L; hemoglobin > 9.0 g/dL; INR/APTT within the normal range
Kidney function
serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min
Liver function
AST/ALT ≤ 3 x ULN; total bilirubin ≤ 1.5 x ULN
Requirements for hematology: i, neutrophils ≥ 1500 x 10^9/L; ii, platelets ≥ 100 x 10^9/L; iii, hemoglobin > 9.0 g/dL; iv, serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min; v, aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 x ULN; vi, total bilirubin ≤ 1.5 x ULN; vii. forced expiratory volume in the first second (FEV1) ≥ 1.2 L or > 40% predicted; viii. International Normalized Ratio/activated partial thromboplastin time (INR/APTT) within the normal range
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06598527 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require EGFR?
Yes, EGFR mutation is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK fusion is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIA or IIB or IIIA or IIIB (T3-4N2) is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify