Phase III, Multicenter, Randomized Controlled Clinical Study of Three-Dimensional Radiotherapy for Primary Tumors in Non-Oligometastatic Stage IV Non-Small Cell Lung Cancer

NCT07462728 | Not Yet Recruiting

• 1 other identifier: FZ 2025-09-246
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

For patients with non-small cell lung cancer and more than five metastatic lesions (non-oligometastatic disease), does radical treatment of the primary lung lesion, in addition to pharmacotherapy, also provide benefits in terms of progression-free survival (PFS) and local control? Currently, there is limited clinical research on combining pharmacotherapy with radiotherapy for the primary lesion in non-oligometastatic patients. Therefore, this study aims to investigate whether radical radiotherapy targeting the primary lung lesion, in addition to pharmacotherapy, can improve local control and survival in non-oligometastatic patients, and whether the associated toxicities are acceptable.

Conditions

Radiotherapy; Non Small Cell Lung Cancer Metastatic

Keywords

non-oligometastatic NSCLC; radical radiotherapy of the primary lung lesion; pharmacotherapy with radiotherapy for the primary lesion

Outcome Measures

Primary Outcomes (1)

• Overall Survival, Local regional progressive-free survival, LRPFS

  OS refers to the period the date of randomization in a clinical trial until the patient dies from any cause. Local progression-free survival time refers to the duration from randomization until the first occurrence of local progression at the primary tumor site or region, or death from any cause

  From enrollment to the end of treatment at 1 year

Secondary Outcomes (3)

• ORR,

  From enrollment to the end of treatment at 1year.

• PFS

  From enrollment to the end of treatment at 1 year

• Toxicities

  From enrollment to the end of treatment at 1 year

Study Arms (2)

Pharmacotherapy group

NO INTERVENTION

For patients positive for driver gene mutations, first-line targeted therapy with or without chemotherapy is recommended according to NCCN guidelines. For patients negative for driver gene mutations, first-line immunotherapy combined with chemotherapy is recommended according to NCCN guidelines.

Radiotherapy group

EXPERIMENTAL

For patients positive for driver gene mutations, first-line targeted therapy with or without chemotherapy is recommended according to NCCN guidelines. For patients negative for driver gene mutations, first-line immunotherapy combined with chemotherapy is recommended according to NCCN guidelines. Concurrent radiotherapy for the primary tumor in combination with drug therapy.

Radiation: Three-Dimensional Radiotherapy for Primary lungTumors

Interventions

Three-Dimensional Radiotherapy for Primary lungTumors RADIATION

The experimental group received radical radiotherapy for the primary lung lesion in combination with first-line drug therapy recommended by the NCCN guidelines.

Radiotherapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically or cytologically confirmed stage IV NSCLC \[9th edition, 2024\];
• Non-oligometastatic disease (number of metastatic lesions \> 5, regardless of the number of organs involved); patients with brain metastases must be conscious; the number of lung metastases must not affect lung function and allow for possible primary tumor radiotherapy;
• Treatment-naïve (no prior antitumor therapy); or disease control after 1-3 months of monotherapy with TKI, ALK inhibitor/ROS inhibitor; or disease control after 4-6 cycles of chemotherapy combined with immunotherapy;
• Age 18-80 years, ECOG 0-2 or KPS ≥70; no contraindications to radiotherapy, EGFR-TKI, ALK/ROS1 inhibitors, chemotherapy, or immunotherapy;
• No major organ dysfunction, or laboratory test results must meet the following criteria: Hematology , cardiac function, liver function , and renal function within normal ranges according to respective laboratory standards. Pulmonary function : FEV1 \>50%, mild to moderate impairment of lung function.
• Signed informed consent before treatment (for radiotherapy, chemotherapy, immunotherapy, and targeted drug therapy);
• Good patient compliance with the treatment and follow-up.

You may not qualify if:

• Stage I-III NSCLC, oligometastasis (number of metastatic lesions ≤ 5), Stage IV NSCLC with malignant serous cavity effusion, or KPS ≤ 60;
• Patients with extensive liver metastases or lung metastases that have severely impaired liver or lung function;
• Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, symptomatic congestive heart failure within the past 12 months, or uncontrolled arrhythmia; clinically diagnosed valvular heart disease; active bacterial, fungal, or viral infections; mental disorders; severe pulmonary dysfunction;
• Pregnant or lactating patients;
• Patients with a history of other active malignant tumors prior to enrollment, except for non-small cell lung cancer; excluding non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, and cured early-stage prostate cancer;
• Patients with allergic constitution or known/suspected allergy to any investigational drugs without alternative medications;
• Patients with poor compliance; Patients deemed unsuitable for participation in this trial by the investigator.

Sponsors & Collaborators

• Guizhou Medical University: lead

Central Study Contacts

Bing Lu

CONTACT

+86 13809432527; lbgymaaaa@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: March 10, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03