Phase III, Multicenter, Randomized Controlled Clinical Study of Three-Dimensional Radiotherapy for Primary Tumors in Non-Oligometastatic Stage IV Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Three-Dimensional Radiotherapy for Primary lungTumors.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer Metastatic, Radiotherapy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Radiation Three-Dimensional Radiotherapy for Primary lungTumors
The experimental group received radical radiotherapy for the primary lung lesion in combination with first-line drug therapy recommended by the NCCN guidelines.
Primary outcome measures
- Overall Survival, Local regional progressive-free survival, LRPFS [Time frame: From enrollment to the end of treatment at 1 year]
Secondary outcome measures (3)
- ORR, [Time frame: From enrollment to the end of treatment at 1year.]
- PFS [Time frame: From enrollment to the end of treatment at 1 year]
- Toxicities [Time frame: From enrollment to the end of treatment at 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07462728 · FZ 2025-09-246