driver gene-negative advanced non-small cell lung cancer
Conditions
Interventions
Spatially fractionated radiotherapy group:Spatially Fractionated Radiotherapy +serplulimab+platinum-based doublet chemotherapy
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Agree to follow the trial treatment plan and visit schedule, voluntarily join the study, and sign the written informed consent; age >= 18 years, any gender. 2. Histologically confirmed: advanced NSCLC (stage IIIB/C-IV) confirmed by pathology or cytology. 3. Driver gene negative: EGFR (exon 19 deletion/L858R etc.), ALK, ROS1, BRAF V600E, KRAS G12, METex14 skipping mutation, RET fusion, etc. are all negative (confirmed by NGS or PCR testing). PD-L1 expression is not limited (but TPS score should be recorded for subgroup analysis). 4. ECOG PS 0-2, expected survival >= 3 months. 5. At least one measurable lesion, with tumor lesion maximum diameter >= 4 cm. 6. Sufficient organ function (such as bone marrow, liver, and kidney function meeting immunotherapy requirements), defined as follows: (1) Hemoglobin >= 9.0 g/dL (measured within 15 days before enrollment); (2) Absolute neutrophil count (ANC) >= 1500/mm^3 (measured within 15 days before enrollment); (3) Platelet count >= 100,000/mm^3 (measured within 15 days before enrollment); (4) Total bilirubin 60 ml/min for patients with creatinine > 1.5 x ULN (measured within 15 days before enrollment). 7. Males and females of childbearing potential agree to use effective contraception from the time of signing the informed consent until the end of follow-up; females of childbearing potential must have a negative pregnancy test within 7 days before signing the informed consent.
Exclusion criteria
Exclusion criteria: 1.Histologically confirmed small cell lung cancer (SCLC) or tumors with small cell carcinoma components. 2.Positive for driver gene mutations, including EGFR, ALK, ROS1, RET, MET, BRAF, etc. 3.Patients with any comorbid systemic disease or severe concurrent medical condition that, in the opinion of the investigator, may preclude enrollment or confound the accurate evaluation of the safety and tolerability of the investigational regimen. 4.Patients with any comorbidity that would limit life expectancy to =6 months, or any uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric disorders/social circumstances that would compromise compliance with study requirements, are excluded. 5.History of primary active immunodeficiency. 6.Known positive test for human immunodeficiency virus (HIV) (HIV 1/2 antibody positive) or active pulmonary tuberculosis infection. 7.Patients with known active hepatitis infection, defined as seropositivity for HCV antibody, HBsAg, or anti-HBc at screening, are excluded. Exceptions apply: participants with prior or resolved HBV infection (anti-HBc positive, HBsAg negative) are eligible; participants with positive HCV antibody are eligible only if HCV RNA (PCR) is negative. 8.Patients with any concurrent active malignancy or evidence of metastatic disease (other than the current NSCLC) are excluded. 9.Patients with prior SFRT who do not meet the definition of radio-insensitivity (i.e., are considered radiosensitive) are excluded. 10.History of allergy to PD-1/PD-L1 inhibitors. 11.Patients who are pregnant or breastfeeding are not eligible for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Overall Survival (OS);Incidence and Severity of Treatment-Related Adverse Events (TRAEs); | — |
Countries
China
Contacts
Public ContactXiaomei Gong
Shanghai Pulmonary Hospital
Outcome results
None listed