ctDNA Monitoring Guides the Treatment of NSCLC With Befotertinib Combined With Radiotherapy (NCT07410611) | Clinical Trial Compass
Not Yet RecruitingPhase 2
ctDNA Monitoring Guides the Treatment of NSCLC With Befotertinib Combined With Radiotherapy
China84 participantsStarted 2026-02-10
Plain-language summary
Befotertinib is a third-generation EGFR-TKI independently developed in China. In first-line treatment of advanced non-small cell lung cancer (NSCLC) with EGFR mutations, it has demonstrated a median progression-free survival (PFS) of 22.1 months, representing the longest reported PFS data among currently available third-generation EGFR-TKIs. Building on the clinical advantages of this agent and addressing the unmet therapeutic needs in oligometastatic NSCLC, this study aims to conduct a prospective exploration by dynamically monitoring circulating tumor DNA (ctDNA) to guide the application of befotertinib combined with radiotherapy in patients with EGFR mutation-positive oligometastatic NSCLC.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18-75 years at the time of signing the informed consent form, both males and females are eligible;
. Histologically confirmed newly diagnosed or treatment-naïve oligometastatic stage IV NSCLC (AJCC 9th edition) with ≤3 involved organs and ≤5 metastatic lesions. Regional lymph node involvement (regardless of number) is not counted as metastatic sites; non-regional lymph node involvement is classified as a metastatic lesion;
. Presence of an EGFR sensitizing mutation (19Del or 21L858R);
. At least one measurable lesion according to RECIST v1.1;
. ECOG performance status 0-1;
. Life expectancy ≥12 weeks;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival
Timeframe: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 mont
2
PFS
Timeframe: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 22 months
. No prior systemic anti-tumor therapy for advanced NSCLC, including standard chemotherapy, biologic therapy, targeted therapy, immunotherapy, or investigational drug treatment before starting the study drug. Patients who have received adjuvant or neoadjuvant therapy (chemotherapy and/or radiotherapy) are eligible if there has been no progression within 6 months after completion of such therapy;
. Adequate organ function (no transfusion, growth factor support, or medical correction within 14 days before screening):
Exclusion criteria
. Small cell lung cancer or non-small cell lung cancer mixed with histologic types such as small cell lung cancer or neuroendocrine carcinoma;
. Confirmed EGFR exon 20 insertion mutation or non-classical mutations such as L861Q, G719X, or S768I;
. Prior systemic anti-tumor therapy for advanced/metastatic NSCLC (e.g., standard chemotherapy, targeted therapy, biologic therapy, immunotherapy, etc.);
. Patients with symptomatic brain metastases, carcinomatous meningitis, or spinal cord compression, or imaging (CT or MRI) findings of brain or leptomeningeal disease at screening (except those with previously treated brain metastases who have been stable and without progression for ≥4 weeks before enrollment, and confirmed by brain MRI, CT, or venography to have no evidence of intracranial hemorrhage);
. Known history of hypersensitivity to the active or inactive excipients of Befotertinib or to drugs with similar chemical structures or classes;
. Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.;
. History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring steroid treatment;
. Any evidence of severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes, active bleeding, etc., that in the investigator's judgment would compromise patient participation or protocol compliance, or any active infection including uncontrolled hepatitis B, hepatitis C, or human immunodeficiency virus (HIV);