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Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT06313541•Fudan University

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

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;
•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;
+1 more criteria

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;
+5 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Key Dates

Start Date

April 10, 2024

Primary Completion Date

June 30, 2025

Completion Date

December 31, 2025

Last Updated

June 5, 2024

Enrollment

146

ESTIMATED participants

Conditions

NSCLC Stage IV

Interventions

SBRT or LDRT

RADIATION

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

DRUG

Contacts

Zhengfei Zhu

CONTACT

+86-18017312901 fuscczzf@163.com

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NSCLC Stage IV

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

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