NCT06020430 Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy
| NCT ID | NCT06020430 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hubei Cancer Hospital |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2024-02-08 |
| Primary Completion | 2026-02-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 134 participants in total. It began in 2024-02-08 with a primary completion date of 2026-02-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Frequently Asked Questions
Who can join the NCT06020430 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06020430 currently recruiting?
Yes, NCT06020430 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hubei Cancer Hospital to inquire about joining.
Where is the NCT06020430 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06020430 clinical trial?
NCT06020430 is sponsored by Hubei Cancer Hospital. The trial plans to enroll 134 participants.
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