Resectable stage II–III driver-gene-negative non-small-cell lung cancer
Conditions
Interventions
Intervention group:Sequential Stereotactic Radiotherapy Followed by Iparomlimab and Tuvonralimab in Combination with Chemotherapy
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent form (ICF); 2. When signing ICF, age >= 18 years old, gender unlimited; 3. Resectable stage II-III driver gene negative NSCLC confirmed by histology and / or cytology (diagnosed according to the International Association for the study of lung cancer [iaslc] chest tumor staging manual / American Joint Committee on cancer [ajcc] 8th Edition); For suspicious lesions that are suspected by imaging examination but normal by clinical judgment, which can lead to changes in TNM staging, including but not limited to contralateral mediastinal lymph nodes, supraclavicular lymph nodes, solid / sub solid lung nodules, and non simple ground glass degeneration (GGO), it is strongly recommended to perform pathological puncture verification; 4. According to the curative effect evaluation standard version of solid tumor (RECIST 1.1), there are measurable lesions; 5. The ECoG physical status score is 0-1 (see Appendix 2); 6. The subject must provide tumor tissue for PD-L1 expression level detection. See the laboratory operation manual for the requirements of tissue samples; 7. Have adequate organ and bone marrow function (in the state of no blood transfusion and no use of hematopoietic stimulating factor drugs within 14 days): 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 by Cockcroft Gault formula); 6) Coagulation function: international normalized ratio (INR) 50%; 8. Estimated survival >= 6 months; 9. According to the surgeon's assessment, it meets the requirements of radical surgery, and the total lung function can withstand the proposed pulmonary resection; 10. Female subjects of childbearing age must have a serum pregnancy test within 7 days before randomization, and the result is negative, and agree to use reliable and effective methods of contraception (whichever is the longest) during the test and within 5 months (ipaloritol vorolizumab) or 6 months (chemotherapy) after the last administration of the test drug. For male subjects whose partners are women of childbearing age, they must agree to use reliable and effective methods of contraception (whichever is the longest) during the trial and within 5 months (ipaloritol vorolizumab) or 6 months (chemotherapy) after the last administration of the trial drug.
Exclusion criteria
Exclusion criteria: 1. Tumor histology or cytological pathology confirmed or combined with neuroendocrine carcinoma (large cell, small cell, carcinoid, etc.), or sarcoma / sarcomatoid lesions, or adenosquamous carcinoma, or special pathological types (such as smarca4 deletion type, etc.); 2. Previous treatment with another drug targeting T cell receptor (such as CTLA-4, OX-40, etc.); 3. Participants with known EGFR sensitive mutations or ALK translocations, non squamous cancer subjects need to clarify the EGFR and alk mutation status; 4. Superior sulcus tumor or locally advanced unresectable or metastatic disease; Non resectable N2 patients included partial stage ? a, ? B and all stage ? C, N2 patients with single station N2 mediastinal lymph node short diameter = 3 cm or multi station lymph node fusion into clusters, T4 patients with esophageal, cardiac and large blood vessels invasion and all N3 patients; It also includes other cases that are evaluated as unresectable by the multidisciplinary team (MDT); 5. Have previously received any anti-tumor treatment for the study disease (including chemotherapy, radiotherapy, immunotherapy or targeted therapy); They had received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before randomization; 6. Any other malignant tumor diagnosed within 5 years before randomization, except for the cured localized tumors, including cervical carcinoma in situ, skin basal cell carcinoma and low-grade prostate cancer; 7. Participated in clinical trials of other investigational drugs or investigational devices for therapeutic purposes within 4 weeks before randomization; 8. Have received major surgery (except for diagnosis) within 28 days (excluding 28 days) before randomization or are expected to require major surgery during the study period (except for expected radical surgery for non-small cell lung cancer); 9. Subjects who plan to use cisplatin have known or suspected hearing impairment and have two consecutive audiometry > 25dB; 10. Subjects with grade >= 2 peripheral neuropathy; 11. Subjects with known or suspected interstitial pneumonia; Radiation pneumonitis or other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function. Including but not limited to idiopathic pulmonary fibrosis, organized pneumonia / bronchiolitis obliterans, etc; Or evidence of active pneumonia found on chest CT scan screening; 12. Any serious active infection, including active tuberculosis, as well as bacterial, fungal, or viral infections that require systematic treatment within the first 14 days of randomization; 13. Note: The antiviral treatment of active hepatitis B patients who meet the requirements for inclusion is excluded; 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 quantification test result greater than 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 treatments based on clinical judgment during the study period may be considered for enrollment; 14. Individuals with a known history of HIV infection; 15. Accompanied by uncontrollable or significant cardiovascular and cerebrovascular diseases, including but not limited to: 1) New York Heart Associa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Pathological Response (MPR) Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival (EFS);Overall survival (OS);Progression free survival (PFS);Complete pathological remission (pCR) rate; | — |
Countries
China
Contacts
Public ContactHang Yin
Harbin Medical University Cancer Hospital
Outcome results
None listed