Advanced non-small cell lung cancer
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab combined with docetaxel and stereotactic body radiotherapy
Sponsors
chongqing university cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years at enrollment; 2. ECOG performance status of 0-1; 3. Patients with advanced non-small cell lung cancer (NSCLC) who have experienced radiological progression after first-line treatment with PD-(L)1 inhibitors; 4. It has been confirmed that there are no EGFR mutations, ALK fusion positivity, ROS1 positivity.Or other gene mutations suitable for targeted drug treatment; (such as BRAF V600E, MET exon 14 skipping mutation, RET fusion positivity, etc.) who refuses targeted therapy, or the driver gene status is unknown for non-adenocarcinoma patients. 5. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one measurable lesion as evaluated by imaging; 6. At least one non-target lesion can be treated with stereotactic body radiotherapy (SBRT); 7. Expected lifespan >= 3 months; 8. The level of organ function must meet the following requirements: (1) Hematology: a. Haemoglobin (HB) >= 9g / dL b. Neutrophil absolute value (ANC) >= 1.5 × 10^9 / L; c. Platelets (PLT) >= 100 × 10^9 / L; (2)Liver function: a. Total bilirubin (TBiL) = 30g / L; (3)Renal function: Calculated creatinine clearance rate (CrCl) >= 60 mL / min (using the standard cockcroft-Gault formula) or serum creatinine = 50%; (5)12-lead ECG: QT interval < 480 ms; (6)Coagulation function: International standardized ratio (INR), activated partial coagulation APTT and PT <= 1.5 × ULN; 9.For female subjects of childbearing age (theoretically 15-49 years old, including unmarried, married or widowed), the serum pregnancy test must be negative within 3 days before the first medication administration; female subjects of childbearing age must have adopted an acceptable contraceptive method since the screening stage and must agree to continue using the contraceptive method for at least 6 months after the last administration of the study drug; for unsterilized male subjects, they must have adopted an acceptable contraceptive method since the screening stage until at least 6 months after the last administration; the specific time to stop contraception should be determined by the investigator; 10.Willingness to participate voluntarily, provision of informed consent, adherence to study protocol, and cooperation with follow-up assessments.
Exclusion criteria
Exclusion criteria: 1. There are other components in the tissue or cell pathology except for NSCLC; 2. In addition to NSCLC, the patients had suffered from other types of malignant tumors within the five years prior to the first administration of the medication, including those that were cured after adequate treatment; 3. Received radiotherapy within 4 weeks before enrollment; 4. Patients with brain metastases accompanied by symptoms or with symptom control duration less than 2 months; 5. Abdominal effusion and pleural effusion that require immediate clinical intervention, as well as pericardial effusion with clinical symptoms or the need for drainage; 6. Active hepatitis B patients (HBsAg positive and HBV-DNA exceeding 1000 copies/ml (200 IU/ml) or above the detection limit); Active hepatitis C patients (HCV antibody positive and HCV-RNA level above the detection limit); 7. Patients who have previously received chest radiotherapy and whose cumulative radiation dose may have exceeded the tolerable level; 8. History of immunodeficiency, including those with Human Immunodeficiency Virus (HIV) infection; 9. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 10. Patients who did not recover to NCI-CTC AE 10 mg of prednisone or equivalent daily) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.) within 30 days before the first study drug administration. Local use of corticosteroids, nasal sprays and inhaled corticosteroids is allowed. Systemic corticosteroids for the prevention of contrast agent allergy are also allowed; 17. Previous or current interstitial pneumonia/lung disease that requires systemic hormone therapy; 18. Previously received treatment other than anti-PD-(L)1 immune checkpoint inhibitors, including anti-CTLA-4 antibodies, anti-LAG-3 antibodies, anti-TIM-3 antibodies, etc; 19. There have been cases in the past where immune-related adverse reactions occurred, leading to the termination of anti-PD-(L)1 treatment; 20. Have other underlying diseases that are not well controlled, infections, treatment issues, or abnormal laboratory test results. These factors may confound the research results, prevent the subjects from fully participating in the study, or make their participation in the study not in their best interests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;disease control rate;Safety;Duration of Response;Overall survival; | — |
Countries
China
Contacts
Public Contactwei zhou
chongqing university cancer hospital
Outcome results
None listed