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NCT Number: NCT06020430

Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Immunotherapy Locally Advanced Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Radiotherapy Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed non-small cell lung cancer;
  • 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);
  • inoperable or refuses surgery after induction therapy with immunotherapy and chemoradiotherapy;
  • After ≥2 cycles of induction chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);
  • performance status 0-1;
  • measurable or evaluable lesions;
  • Survival expectancy is not less than 6 months;
  • adequate cardiac, pulmonary, renal, and hepatic and bone marrow function

Exclusion criteria

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

Treatment and study plan

CTV omitted or delineated

Radiation

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.

Primary outcomes

  1. grade 2 or more pneumonitis

    Time frame: up to 6 months

Secondary outcomes

  1. local/regional control rate

    Time frame: up to 12 months

  2. Progress free survival

    Time frame: up to 12 months

  3. grade 3 or more pneumonitis

    Time frame: up to 6 months

  4. grade 3 or more esophagitis

    Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

Hubei Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 31, 2023
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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