Oligometastatic non-small cell lung cancer with negative driver genes
Conditions
Interventions
Experimental group:Maintenance immunotherapy and radiotherapy to the primary and/or oligometastatic lesions
Control group:Only maintenance immunotherapy
Sponsors
Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients who meet the following criteria are eligible to participate in the trial: 1. Patients with non-small cell lung cancer with oligometastasis diagnosed by pathology at the initial treatment, with no more than 3 metastatic organs and no more than 5 lesions; 2. Have received first-line standard chemotherapy and achieved a complete response (CR), partial response (PR), or stable disease (SD) after treatment; 3. Have PD-L1 expression detected at the time of diagnosis of non-small cell lung cancer with oligometastasis, and PD-L1 TPS is 0-49%; 4. Can tolerate the radiotherapy process, such as being able to maintain a fixed position and maintaining the position; 5. Age is 18 to 75 years old; 6. Weight is >= 40 kg; 7. Expected lifespan is >= 12 weeks; 8. Physical status score of "Eastern Cooperative Oncology Group (ECOG)" is 0, 1, or 2 (see Appendix 2); 9. Have been 4-6 weeks since the previous chemotherapy, and all adverse events caused by previous treatment have recovered to = 1.5 × 10^9/L; Platelets >= 100 × 10^9/L; Hemoglobin >= 90 g/L (without blood transfusion within 14 days); Serum Cr 50 ml/min (Cockcroft-Gault formula); AST <= 2.5 × ULN; ALT <= 2.5 × ULN; if there is liver metastasis, then ALT and AST <= 5 × ULN; Total bilirubin <= 1.5 × ULN (except for those with Gilbert syndrome, the total bilirubin of these subjects must be < 51.3 µmol/L); TSH, FT3, FT4 are within the normal range +/- 10%. 11. Patients who have received previous treatment for brain metastases are allowed to be included. To meet the inclusion criteria, the following conditions must be met: Have completed radical radiotherapy (such as stereotactic radiosurgery) or systemic treatment for brain metastases; No CNS lesions progression in the imaging assessment before enrollment; No new neurological symptoms or worsening of existing symptoms. Note: For patients with brain metastases who have received local treatment, the latest follow-up brain imaging data (recommended MRI) after the last treatment should be provided at the baseline assessment. 12. Sign a written informed consent form
Exclusion criteria
Exclusion criteria: Patients meeting any of the following conditions will be excluded from the trial: 1. Patients with positive EGFR, ALK, or ROS-1 mutations; 2. Patients with undetectable PD-L1 or with a level greater than 50%; 3. Patients who, based on imaging or clinical assessment, have been confirmed to have the following conditions after first-line systemic treatment until enrollment: Presenting with relevant neurological symptoms (such as new or aggravated headache, focal neurological deficits, epilepsy, etc.) and requiring adjustment of the treatment plan (such as increasing the dose of glucocorticoids or emergency radiotherapy). 4. Patients with meningeal metastasis or pleural metastasis; 5. Patients with active, known or suspected autoimmune diseases. Patients with the following conditions can be enrolled: vitiligo, type 1 diabetes, residual hypothyroidism caused by autoimmune thyroiditis that only requires hormone replacement therapy, or conditions that are expected not to recur without external factors stimulating; 6. Judging from chest X-ray examination, sputum examination, and clinical examination, there is active tuberculosis (TB) infection. Patients with a history of active TB infection within the previous 1 year, even if treated, will be excluded. Patients with a history of active TB infection more than 1 year ago will also be excluded, unless it can be proven that the previous anti-TB treatment was sufficient and effective; 7. Patients with a known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); 8. Complications requiring immunosuppressive drug treatment, or complications requiring systemic or local use of corticosteroids at immunosuppressive doses; 9. Pregnant or breastfeeding; 10. Unable to undergo venipuncture and/or unable to tolerate venous access; 11. Any other conclusive medical reasons, psychiatric reasons, or social reasons determined by the investigator; 12. Patients with severe interstitial lung disease and symptoms, or when dealing with suspected drug-related pulmonary toxicity, it may cause interference; 13. Patients with other malignant tumors (excluding non-melanoma skin cancer and the following in situ cancers: bladder, stomach, colon, endometrium, cervical/abnormal hyperplasia, melanoma or breast cancer) who have not been completely relieved at least 2 years before enrollment, and do not require other treatment or do not require other treatment during the study; 14. Diseases that the investigator considers as causing harm to the administration of the study drug or that lead to difficulty in determining toxicity when assessing adverse events. The underlying diseases that the investigator considers as potentially causing harm to the administration of the study drug or that lead to difficulty in determining toxicity when assessing adverse events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Safety;Objective Tumour Response (ORR);Disease control rate(DCR);Duration of continuous relief; | — |
Countries
China
Contacts
Public ContactNan Bi
Chinese Academy of Medical Sciences Cancer Hospital
Outcome results
None listed