A Multicenter, Randomized Controlled Clinical Trial of Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy

Fudan University1 site in 1 country146 target enrollmentApril 10, 2024

ConditionsNSCLC Stage IV

InterventionsPD-1/PD-L1 inhibitor combined with platinum-based chemotherapy SBRT or LDRT

DrugsPD-1/PD-L1 inhibitor combined with platinum-based chemotherapy

Overview

Phase: Phase 2
Intervention: PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy
Conditions: NSCLC Stage IV
Sponsor: Fudan University
Enrollment: 146
Locations: 1
Primary Endpoint: Progression Free Survival
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 10, 2024

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Zhengfei Zhu

Professor

Fudan University

Eligibility Criteria

Inclusion Criteria

•ECOG functional status score was 0-
•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;

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;

Arms & Interventions

PD-1/PD-L1 inhibitor combined with chemotherapy

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

Treatment response adapted hybrid radiotherapy plus PD-1/PD-L1 inhibitor and chemotherapy

Intervention: SBRT or LDRT

Treatment response adapted hybrid radiotherapy plus PD-1/PD-L1 inhibitor and chemotherapy

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

Outcomes

Primary Outcomes

Progression Free Survival

Time Frame: Two years

The time from enrollment to disease progression or death from any cause. Patients who were still alive at the time of analysis will have the date of their last contact as the cutoff date.