lung cancer
Conditions
Interventions
SMARCA4-deficient group:QL1706 and Platinum-Based Chemotherapy
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntary participation and provision of signed written informed consent. 2. Age >= 18 years. 3. Life expectancy >= 3 months. 4. Histologically or cytologically confirmed diagnosis of Stage IIIB-IV lung cancer that is not amenable to curative surgery or radiotherapy. 5. Tumor demonstrates loss of BRG1 protein (encoded by the SMARCA4 gene) as confirmed by immunohistochemistry (IHC). 6. No prior systemic anti-cancer therapy for advanced disease. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Willingness to provide archived or fresh tumor tissue samples from primary or metastatic lesions. If unavailable, enrollment may be permitted following investigator assessment. 9. At least one measurable lesion as defined by RECIST v1.1. 10. Adequate organ function within the screening period, as evidenced by: 1) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L 2) Platelet count >= 100 × 10^9/L 3) Hemoglobin >= 90 g/L (without transfusion within 14 days) 4) Serum creatinine 50 mL/min (calculated by Cockcroft-Gault formula) 5) AST and ALT <= 2.5 × ULN (<= 5 × ULN for patients with liver metastases) 6) Total bilirubin <= 1.5 × ULN (except for participants with Gilbert's syndrome) 7) TSH, FT3, and FT4 within normal limits (+/-10%);
Exclusion criteria
Exclusion criteria: 1. Pathological diagnosis contains small cell components; 2. Symptomatic brain metastases; 3. Meningeal metastasis; 4. If the patient has received postoperative adjuvant therapy in the past and has relapsed within 6 months of the last treatment; 5. Active, known or suspected autoimmune diseases (except vitiligo, type I diabetes, residual hypothyroidism caused by autoimmune thyroiditis that only needs hormone replacement treatment, or diseases that are not expected to recur without stimulation of external factors); 6. Determine the presence of active pulmonary tuberculosis (TB) infection based on chest X-ray examination, sputum examination, and clinical physical examination. 7. Complications that require treatment with immunosuppressive drugs, or complications that require systemic or local use of corticosteroids at doses with immunosuppressive effects; 8. Female subjects are pregnant or breastfeeding; 9. The subject suffers from interstitial lung disease, which has symptomatic manifestations or may cause interference in the detection or management of suspected drug-related pulmonary toxicity; 10. Human immunodeficiency virus antibody (HIVAb) positive, active hepatitis B virus infection (HBsAg positive and HBV-DNA>10 ^ 3 copies/ml), or hepatitis C virus infection (HCV antibody positive and HCV-RNA>research center detection limit); 11. History of serious neurological or psychiatric disorders, including but not limited to: dementia, depression, epileptic seizures, bipolar disorder, etc; 12. Have received any other unlisted clinical investigational drugs or treatments within 4 weeks prior to the first study administration; 13. Use any traditional Chinese patent medicines and simple preparations with anti-tumor activity within 2 weeks before using the study drug; 14. Subjects with other malignant tumors (excluding non melanoma skin cancer and the following cancers in situ: bladder, stomach, colon, endometrium, cervical/dysplasia, melanoma or breast cancer) in the past shall not be included in the study, unless he/she has completely alleviated at least 2 years before joining the study, and does not need to receive other treatment or does not need to receive other treatment during the study; 15. History of severe heart disease or cerebrovascular disease, such as heart failure with NYHA grade >= 2, acute coronary syndrome (such as myocardial infarction, unstable angina, etc.) occurring within the 6 months prior to screening, and acute cerebrovascular disease (such as transient ischemic attack, cerebral infarction, cerebral hemorrhage, etc.) occurring within the 6 months prior to screening; 16. Screen for unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism that require treatment intervention within the first 6 months; Excluding thrombosis related to infusion devices; 17. Subjects who have received live vaccines within 28 days prior to planned or initial study administration; 18. Have undergone major surgery or significant trauma within 4 weeks prior to the start of the first study administration; 19. Patients with swallowing difficulties, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation, etc. that affect oral drug absorption (frequent vomiting, diarrhea, etc.); 20. Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment, defined as persistent signs/symptoms associated with the infection that have not improved des
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| biomarker analysis;Overall survival, OS;Objective relief rate;safety analysis; | — |
Countries
China
Contacts
Public ContactZhijie Wang
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed