Non-small cell lung cancer (NSCLC), stage II-III, driver gene negative, resectable or potentially resectable
Conditions
Interventions
Trial group (SBRT followed by Retlirafusp alfa combined with chemotherapy as neoadjuvant therapy ? surgery ? Retlirafusp alfa as adjuvant therapy):Stereotactic body radiotherapy (SBRT) followed by Ret
Sponsors
harbin medical university cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily joins this study and signs the informed consent form (ICF); 2. At the time of signing the ICF, age >= 18 years, male or female; 3. Histologically and/or cytologically confirmed as resectable stage II-IIIA or potentially resectable stage T3-4N2-IIIB driver gene-negative NSCLC (diagnosed according to the International Association for the Study of Lung Cancer [IASLC] Thoracic Oncology Staging Manual / American Joint Committee on Cancer [AJCC] 9th edition); for suspicious lesions suggested by imaging examination but judged as normal clinically, which may lead to changes in TNM staging, including but not limited to contralateral mediastinal lymph nodes, supraclavicular lymph nodes, solid/sub-solid pulmonary nodules, and non-pure ground-glass opacities (GGO), pathological puncture verification is strongly recommended; 4. Deemed suitable for neoadjuvant therapy after multidisciplinary team (MDT) consultation; 5. Has measurable lesions according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 7. The subject must provide tumor tissue for PD-L1 expression level testing; 8. Has adequate organ and bone marrow function (within 14 days without blood transfusion or use of hematopoietic stimulating factor drugs for correction): (1) Absolute neutrophil count >= 1.5 × 10^9/L; (2) Platelet count >= 100 × 10^9/L; (3) Hemoglobin >= 90 g/L; (4) Liver function: total bilirubin = 60 mL/min (calculated using the Cockcroft-Gault formula); (6) Coagulation function: international normalized ratio (INR) 50%; 9. Expected survival >= 6 months.
Exclusion criteria
Exclusion criteria: 1. Tumor histology or cytology confirms or coexists with neuroendocrine carcinoma (large cell, small cell, carcinoid, etc.) components, or sarcoma/sarcomatoid lesions, or adenosquamous carcinoma, or special pathological types (such as SMARCA4-deficient type, etc.); 2. Participants with known EGFR sensitive mutations or ALK translocations; non-squamous cell carcinoma subjects must have clear EGFR and ALK mutation status; 3. Pancoast tumor or presence of locally advanced unresectable or metastatic disease; unresectable includes part of stage IIIA, stage IIIB and all stage IIIC, patients with single-station N2 mediastinal lymph node short diameter >=3 cm or multi-station lymph node matting, T4 with invasion of esophagus, heart, or great vessels, and all N3 patients; also includes other conditions assessed as unresectable by the multidisciplinary team (MDT); 4. Prior receipt of any anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, or targeted therapy, etc.) for the study disease; receipt of traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before randomization; 5. Diagnosis of any other malignancy within 5 years before randomization, except for cured localized tumors, including cervical carcinoma in situ, basal cell carcinoma of the skin, and low-grade prostate cancer, etc.; 6. Participation in other therapeutic interventional clinical trials of investigational drugs or devices within 4 weeks before randomization; 7. Receipt of major surgery (excluding diagnostic procedures) within 28 days before randomization (not including 28 days), or anticipated need for major surgery during the study period (excluding the planned radical resection for non-small cell lung cancer); 8. Subjects planned to receive cisplatin who have known or suspected hearing impairment, with two consecutive audiometry measurements >25 dB; 9. Subjects with known or suspected interstitial pneumonia; radiation pneumonitis or other moderate to severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity and seriously affect respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/obliterative bronchiolitis, etc.; or evidence of active pneumonia found on screening chest CT scan; 10. Any severe active infection, including active tuberculosis, as well as bacterial, fungal, or viral infections requiring systemic treatment within 14 days before randomization; Note: Except for antiviral treatment of active hepatitis B patients who meet enrollment criteria; 11. Active hepatitis B virus infection (HBsAg positive and/or HBcAb positive, with HBV-DNA quantification >=2000 IU/mL) or hepatitis C virus infection (HCV antibody positive and HCV-RNA quantitative test result above the lower limit of detection); Note: For active hepatitis B subjects with HBV-DNA <2000 IU/mL, those who are willing to receive entecavir or other antiviral therapy according to clinical judgment during the study period may be considered for enrollment; 12. Known history of HIV infection; 13. Accompanied by uncontrolled or significant cardiovascular and cerebrovascular diseases, including but not limited to: (1) New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina, myocardial infarction, or arrhythmias causing hemodynamic instability within 6 months before randomization; (2) Primary cardiomyopathies (such as d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response rate;Overall Survival;Event-Free Survival;Progression-free survival; | — |
Countries
China
Contacts
Public ContactYin Hang
harbin medical university cancer hospital
Outcome results
None listed