Radiotherapy approach for advanced lung cancer patients responding to immunotherapy and chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study aims to evaluate the effects of omitting the clinical target volume (CTV) in primary tumor radiotherapy for patients with advanced non-small cell lung cancer (NSCLC) who have responded to immunotherapy and chemotherapy. The study will assess outcomes related to pneumonitis, local tumor control, and overall survival. Previous findings suggest that omitting CTV radiation may reduce the incidence of pneumonitis without compromising local control and survival rates. The goal is to optimize treatment while preserving immune function to enhance the benefits of immunotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically or cytologically confirmed advanced non-small cell lung cancer (according to the 8th edition of the TNM cancer staging system of AJCC and UICC);
2. After over two cycles of chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);
3. Age 18 to 80 years old, performance status 0-1;
4. measurable or evaluable lesions;
5. Survival expectancy is not less than 6 months;
6. adequate cardiac, pulmonary, renal, and hepatic and bone marrow function

Exclusion Criteria:

1. tumor progress after therapy with immunotherapy and chemotherapy
2. EGFR, ALK, or ROS1 mutation;
3. Previous thoracic radiotherapy;
4. grade 2 or more immune-related adverse events after induction immunotherapy
5. Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ);
6. Pregnant or lactating women
7. undergoing other clinical trials;
8. Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes;
9. Patients with HIV positive and undergoing antiviral therapy;
10. Active tuberculosis

Where it's running

• Hubei Cancer Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Guang Han, PhD — Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Guang Han, PhD
• Email: hg7913@hotmail.com
• Phone: +86 13886048178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.