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.
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;
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;
Parallel
Three-Dimensional Radiotherapy for Primary lungTumors
RadiationThe experimental group received radical radiotherapy for the primary lung lesion in combination with first-line drug therapy recommended by the NCCN guidelines.
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
ORR,
ORR define the objective response rate according to RECIST version 1.1.
PFS
PFS, definehe length of time during and after treatment that a patient lives with the disease but it does not get worse. It is typically measured from the start of treatment until disease progression or death from any cause.
Toxicities
Toxicities: The primary assessment of radiotherapy-related toxicities is based on the CTC 5.0 criteria, focusing on treatment-related toxicities such as radiation pneumonitis, radiation esophagitis, bone marrow suppression, and hematologic toxicities affecting the liver and kidneys. And the time without cancer worsening or death
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