Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy

Non Small Cell Lung Cancer Clinical Trial

Official title:

Omitting CTV Radiotherapy for Locally Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06020430
• Other study ID #: OMCTV-HC-001
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: October 8, 2027

Study information

• Verified date: March 2024
• Source: Hubei Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: October 8, 2027
• Est. primary completion date: February 8, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Immunotherapy
• Locally Advanced
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Radiotherapy

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
China	Hubei Cancer Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Hubei Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	grade 2 or more pneumonitis		up to 6 months
Secondary	local/regional control rate		up to 12 months
Secondary	Progress free survival		up to 12 months
Secondary	grade 3 or more pneumonitis		up to 6 months
Secondary	grade 3 or more esophagitis		up to 6 months