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

NCT07014202 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2025-07-30

No results posted yet for this study

Summary

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

Interventions

COMBINATION_PRODUCT

Immunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapy

Immunotherapy (with or without chemotherapy) maintenance therapy combined with radiotherapy in patients with advanced NSCLC who have not progressed after 4-6 cycles of first-line platinum-containing chemotherapy combined with immunotherapy and who have an oligo-residual status confirmed by PETCT.

DRUG

Immunotherapy (with or without chemotherapy) maintenance therapy

Immunotherapy (with or without chemotherapy) maintenance therapy in patients with advanced NSCLC who have not progressed after 4-6 cycles of first-line platinum-containing chemotherapy combined with immunotherapy and who have an oligo-residual status confirmed by PETCT.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Zhijie Wang · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-11
Primary Completion
2027-09-01
Completion
2027-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07014202 on ClinicalTrials.gov