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RecruitingNCT06020430Updated Mar 15, 2024

Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy

An interventional study of CTV omitted or delineated in Non Small Cell Lung Cancer, Locally Advanced and Radiotherapy, sponsored by Hubei Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Hubei Cancer Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Non Small Cell Lung Cancer
  • Locally Advanced
  • Radiotherapy
  • Immunotherapy

Keywords

  • omitting CTV
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 134 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Hubei Cancer Hospital is the lead sponsor of 25 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
134 participants (estimated)

Study arms

  • Experimental
    CTV-omitted

    CTV was omitted for the radical radiotherapy for locally advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.

    Radiation: CTV omitted or delineated

  • Active comparator
    CTV-delineated

    CTV was delineated for the radical radiotherapy for locally advanced NSCLC who responded to induction therapy with immunotherapy and chemotherapy.

    Radiation: CTV omitted or delineated

Interventions

  • RadiationCTV 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.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Hubei Cancer Hospital
    Wuhan, Hubei 430079, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06020430
Lead sponsor
Hubei Cancer Hospital
Responsible party
HAN GUANG (Director of the department of Radiotherapy Oncology, Hubei Cancer Hospital) — Principal investigator
First posted
Aug 31, 2023
Start date
Feb 8, 2024
Primary completion
Feb 8, 2026 (estimated)
Completion
Oct 8, 2027 (estimated)
Last update
Mar 15, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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