Phase III, Multicenter, Randomized Controlled Clinical St... | NCT07462728

NCT07462728

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
ORR,	ORR define the objective response rate according to RECIST version 1.1.	From enrollment to the end of treatment at 1year.
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.

Eligibility Module

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.