Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy

Fudan University

Status and phase

Enrolling

Phase 2

Conditions

NSCLC Stage IV

Treatments

Drug: PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy

Radiation: SBRT or LDRT

Study type

Interventional

Funder types

Other

Identifiers

NCT06313541

2024-Lung-LDRT/SBRT

Details and patient eligibility

About

This study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive treatment of advanced NSCLC

Enrollment

146 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

ECOG functional status score was 0-1.
Histologically confirmed stage IV primary NSCLC;
Genetic testing showed that the common driver genes including EGFR, ALK and ROS-1 were negative;
Patients with brain metastases were eligible if they were neurologically asymptomatic and had stable disease without receiving systemic glucocorticoids;
According to the investigator's judgment, the patient does not need to receive palliative radiotherapy for any site at present;
Male/female of childbearing age agreed to use contraception (surgical ligation or oral contraceptive/intrauterine device plus condom) during the trial;
Life expectancy ≥3 months;
One week before enrollment, the organ function level met the following criteria:

① Bone marrow function: hemoglobin ≥80g/L, white blood cell count ≥4.0*10^9/L or neutrophil count ≥1.5*10^9/L, platelet count ≥100*10^9/L;

② Liver: serum total bilirubin level ≤1.5 times upper limit of normal, direct bilirubin level must be ≤1.5 times upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times upper limit of normal;

③ Kidney: serum creatinine < 1.5 times upper limit of normal or creatinine clearance ≥50ml/min, urea nitrogen ≤200mg/L; Serum albumin ≥30g/L;
Patients must be able to understand and voluntarily sign the informed consent form.

Exclusion criteria

The patient had severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.
Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia;
Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation;
History of other malignant tumors;
Patients with active infection, heart failure, myocardial infarction, unstable angina or unstable arrhythmia within the past 6 months;
Medical examination or clinical findings, or other uncontrollable conditions that the investigator considers may interfere with the results or increase the patient's risk of treatment complications;
Patients who were considered by the investigator to have lesions requiring palliative and subtractive radiotherapy;
Mixed with small cell lung cancer components;
Lactating or pregnant women;
Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), organ transplantation or allogeneic stem cell transplantation;
Known HBV, HCV, active pulmonary tuberculosis infection;
Patients had received a cancer vaccine or received another vaccine within 4 weeks before starting treatment (note: injectable seasonal influenza vaccine is usually inactivated, so vaccination is allowed, while intranasal vaccine is usually live attenuated, so it is not allowed);
Patients with concurrent use of other immune agents, chemotherapy drugs, drugs in other clinical studies, and long-term use of cortisol were excluded.
Patients with mental disorders, substance abuse, or social problems that affect adherence were excluded from the study after physician review;
Patients who are allergic to or contraindicated to PD-1 monoclonal antibody or chemotherapy drugs.