RecruitingPhase 2NCT06313541

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


Sponsor

Fudan University

Enrollment

146 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at a personalized radiation approach for patients with advanced (stage IV) non-small cell lung cancer receiving immunotherapy as their first treatment. Based on how well tumors respond after the first round of immunotherapy, radiation is added to specific tumor sites to try to improve overall outcomes. **You may be eligible if...** - You have been diagnosed with stage IV non-small cell lung cancer confirmed by biopsy - Your tumor has been tested and does not have the common driver mutations (EGFR, ALK, or ROS-1 positive) - Your general health score is 0 or 1 (ECOG), meaning you are active and able to care for yourself - If you have brain metastases, they must be stable and not causing symptoms - Your life expectancy is at least 3 months and your organ function is adequate **You may NOT be eligible if...** - Your tumor has EGFR, ALK, or ROS-1 mutations (these patients typically get targeted therapy instead) - You currently need immediate palliative radiation to any site - You have severe heart, kidney, liver, or bone marrow problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSBRT or LDRT

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.

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

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.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT06313541


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