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EGFR tyrosine kinase inhibitors combined with stereotactic radiotherapy for metastatic non-small cell lung cancer (NSCLC): a randomized, controlled, open-label, multicenter phase III study

EGFR tyrosine kinase inhibitors combined with stereotactic radiotherapy for metastatic non-small cell lung cancer (NSCLC): a randomized, controlled, open-label, multicenter phase III study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050607
Enrollment
Unknown
Registered
2021-09-01
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Experimental group:SBRT
Control group:NA

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. ECOG 0 – 2 points; 3. Pathologically diagnosed, driver gene detection is sensitive EGFR mutation, initial treatment of stage IV NSCLC (UICC 8th edition), no previous anti-tumor history; 4. No contraindications to molecular targeted therapy and radiotherapy; 5. Appropriate hematological parameters and liver and kidney functions: Absolute neutrophil count >=1.5x10^9/L; platelet count >=75x10^9/L; serum total bilirubin <= 1.5x upper limit of normal; AST and ALT <= 2.5x upper limit of normal (if abnormal liver function is Caused by tumor, AST and ALT <= 5x upper limit of normal); 6. 2-3 months after EGFR-TKIs treatment, the efficacy of the patient is evaluated as PR or SD (refer to 1.1 RECIST 1.1 for the evaluation of efficacy in solid tumors), and the longest diameter of the primary tumor is <=5cm; 7. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with disease progression or primary lesions larger than 5 cm after EGFR-TKIs treatment; 2. Active pulmonary tuberculosis; 3. Patients with high bleeding risk: (1) Patients with active peptic ulcer lesions in the stomach and fecal occult blood (++); (2) Those with a history of melena and/or hematemesis within 3 months; 3) Those with abnormal coagulation function and bleeding tendency. 4. Patients with grade 3-4 hypertension; 5. Patients with renal insufficiency stage 3 and above; 6. Patients with hand-foot skin reaction >= grade 3 or above; 7. Uncontrolled concomitant diseases within 6 months before the study, including unstable angina pectoris, acute myocardial infarction, cerebrovascular accident, etc.; 8. Pregnant or breastfeeding patients, or those who are fertile without taking contraceptive measures; 9. History of other malignant tumors, but the disease-free survival period is less than 5 years; 10. Patients taking other anti-tumor therapy or participating in other interventional clinical trials at the same time; 11. Patients who cannot adapt to this study due to psychological, family and social reasons.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival;

Secondary

MeasureTime frame
Overall survival;

Countries

China

Contacts

Public ContactLi Yan

West China Hospital, Sichuan University

yy1240@163.com+86 18980606806

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026