Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07014202

Consolidation Radiotherapy vs. Observation in Oligoresidual Advanced Non-Small Cell Lung Cancer After Chemo-Immunotherapy

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-07-30

224

Participants Needed

1

Research Sites

116 weeks

Total Duration

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AI-Summary

What this Trial Is About

This clinical study investigates whether adding local radiation therapy (radiotherapy) to standard maintenance therapy benefits patients with advanced non-small cell lung cancer (NSCLC) who have a limited number of residual tumors after initial treatment. The primary objective is to determine if adding targeted radiation therapy to residual lesions prolongs progression-free survival in NSCLC patients with "oligo-residual lesions" (5 or fewer tumors in no more than 3 organs) following first-line chemoimmunotherapy. Researchers hypothesize that combination therapy will slow cancer progression more effectively than maintenance therapy alone. Eligible participants include adults (18+) with advanced NSCLC who have completed 4-6 cycles of first-line chemoimmunotherapy, show limited residual disease on Positron Emission Tomography-Computed Tomography (PET-CT), and lack specific genetic mutations (Epidermal Growth Factor Receptor \[EGFR\], Anaplastic Lymphoma Kinase \[ALK\], etc.). Patients will be randomized into two groups: Experimental: Continuation of maintenance therapy (immunotherapy alone or with chemotherapy) plus local radiotherapy to all residual tumors Control: Continuation of maintenance therapy only The study aims to answer: Primary: Does adding radiotherapy slow cancer progression more effectively? Secondary: Does it improve overall survival, control residual disease, and what are its effects on safety and quality of life? Participants will: Be randomly assigned to a treatment group Receive their designated treatment Undergo regular check-ups and imaging scans Complete quality of life questionnaires Potentially provide blood samples for research This research will help determine optimal treatment approaches for this specific patient population to improve outcomes and quality of life.

CONDITIONS

Official Title

Consolidation Radiotherapy vs. Observation in Oligoresidual Advanced Non-Small Cell Lung Cancer After Chemo-Immunotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary signed written informed consent and compliance with protocol requirements
  • Age 218 years or older
  • Expected survival time of 3 months or more
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically or cytologically confirmed advanced non-small cell lung cancer
  • Completed 4-6 cycles of first-line platinum-based chemotherapy combined with immunotherapy with no disease progression
  • No more than 5 residual lesions involving no more than 3 organs on PET-CT after treatment
  • All residual lesions can safely receive radiation therapy as assessed by radiation oncologists
  • Ability to tolerate radiotherapy, including maintaining a fixed position
  • At least one measurable lesion among the residual tumors according to RECIST v1.1
  • Agreement to provide archived or fresh tumor tissue samples, or enrollment after investigator assessment if samples unavailable
  • Toxicities from previous therapies recovered to grade 1 or less per NCI-CTCAE v5.0 (with specified exceptions)
  • Laboratory values meeting specified criteria for neutrophils, platelets, hemoglobin, kidney and liver function, and thyroid hormones
Not Eligible

You will not qualify if you...

  • Evidence of previous small cell or mixed small cell/non-small cell lung cancer
  • Genetic mutations requiring targeted first-line therapy, such as EGFR sensitizing mutations or ALK fusion
  • Symptomatic brain metastases
  • Leptomeningeal metastases
  • Active or suspected autoimmune disease (with some exceptions)
  • Active tuberculosis infection or history within the past year without effective treatment
  • Use of immunosuppressive medication or corticosteroids at immunosuppressive doses
  • Pregnancy or breastfeeding
  • Symptomatic interstitial lung disease
  • Positive for HIV, active hepatitis B or C infection
  • History of severe neurological or psychiatric disorders
  • Receipt of other investigational drugs within 4 weeks prior to randomization
  • Use of Chinese herbal medicines with anti-tumor activity within 2 weeks prior to study drug
  • History of other malignancies unless in complete remission for at least 2 years
  • Severe cardiac or cerebrovascular disease within 6 months prior to screening
  • Recent thromboembolic events requiring treatment within 6 months
  • Planned or recent live vaccinations within 28 days prior to randomization
  • Other conditions deemed unsuitable by the investigator for study participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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Research Team

Z

Zhijie Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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