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Clinical Trials in China / NCT06020430
Recruiting Not applicable

Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy

NCT06020430 · tracked via the Priya Life Science China tracker
Sponsor
Hubei Cancer Hospital
Phase
Not applicable
Started
2024-02-08
Last updated
2024-03-15

Condition(s) studied

Non Small Cell Lung CancerLocally AdvancedRadiotherapyImmunotherapy

Investigational drug(s) / intervention(s)

CTV omitted or delineated

CTV omitted or delineated: Patients who responded to the induction therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radical radiotherapy group or CTV-delineated radiotherapy group.

Study summary

Radical radiotherapy is critical for locally advanced non small cell lung cancer(NSCLC ). Our previous sturdy indicated that patients who received induction immunotherapy and subsequent radiotherapy suffered higher proportion of pneumonitis.Grade 2 or more pneumonitis patients have worse prognosis. It is urged to optimize the radiotherapy dose and target volume for patients treated with immunotherapy and radiotherapy. According to retrospective and prospective studies, omitting CTV radiation is feasible for patients undergoing concurrent radio-chemotherapy for locally advanced NSCLC. It is postulated that omitting CTV radiation for patients responded to induction therapy with immunotherapy and chemotherapy will have less pneumonitis without sacrificing the local control rate. Omitting CTV may also retain better immune function which will facilitate the immunotherapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Histologically or cytologically confirmed non-small cell lung cancer; 2. stage IIIA or IIIB or IIIC according to the 8th edition of the TNM cancer staging system of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control（UICC); 3. inoperable or refuses surgery after induction therapy with immunotherapy and chemoradiotherapy; 4. After ≥2 cycles of induction chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend); 5. performance status 0-1; 6. measurable or evaluable lesions; 7. Survival expectancy is not less than 6 months; 8. adequate cardiac, pulmonary, renal, and hepatic and bone marrow function Exclusion Criteria: 1. tumor progress after induction with immunothearoy 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

Primary outcome measure(s)

  • grade 2 or more pneumonitis — up to 6 months

Trial sites (1)

FacilityCityRegionStatus
Hubei Cancer Hospital Wuhan Hubei Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06020430 on ClinicalTrials.gov ↗ ← All trials in China