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

NCT ID: NCT06313541

Condition: NSCLC Stage IV

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Immune Checkpoint Inhibitors

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: SBRT or LDRT
Description: Radiotherapy: (1) Low dose radiotherapy (LDRT) : a dose of 2 Gy/1 Fx was given to all visible lesions in the whole body within 1 week before the first course of PD-1/PD-L1 inhibitor combined with chemotherapy (different parts of the lesion could be irradiated separately, but it was required to be completed within 1 week); (2) SBRT: patients received first-line immunotherapy combined with chemotherapy, and their response was evaluated every 6 weeks. Individualized SBRT was planned based on the treatment responses.
Arm group label: Treatment response adapted hybrid radiotherapy plus PD-1/PD-L1 inhibitor and chemotherapy

Intervention type: Drug
Intervention name: PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy
Description: The control group received standard PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy as first-line treatment, and the experimental group received extra treatment response adapted hybrid radiotherapy.
Arm group label: PD-1/PD-L1 inhibitor combined with chemotherapy
Arm group label: Treatment response adapted hybrid radiotherapy plus PD-1/PD-L1 inhibitor and chemotherapy

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

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Zhengfei Zhu, MD

Phone: +86-18017312901
Email: fuscczzf@163.com

Contact backup:
Last name: Jianjiao Ni, MD

Phone: 13761974092
Email: nijianjiao8@sina.com

Start date: April 10, 2024

Completion date: December 31, 2025

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06313541

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