Befotertinib Plus Chemotherapy With an MRD-guided Adaptive Strategy for Treatment Escalation and … (NCT07709585) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Befotertinib Plus Chemotherapy With an MRD-guided Adaptive Strategy for Treatment Escalation and Response Optimization in EGFR-mutated NSCLC Patients
China124 participantsStarted 2026-07-05
Plain-language summary
This is a multicenter, phase II exploratory clinical trial in untreated patients with EGFR-mutant non-small cell lung cancer (stages IIIB-IV) .All participants will receive oral befotertinib monotherapy for 3 weeks first, then serial minimal residual disease (MRD/MRD) testing is performed to adjust subsequent treatment. Patients with positive MRD will receive 4 cycles of pemetrexed plus platinum chemotherapy; patients with negative MRD will continue single-agent befotertinib. After induction, maintenance therapy will be given according to follow-up MRD results. The primary goal is to evaluate progression-free survival guided by dynamic MRD monitoring, and secondary endpoints include objective response rate, disease control rate, safety and MRD clearance rate.
Who can participate
Age range
18 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
. Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC).
. Age ≥18 years, any gender.
. Confirmed EGFR exon 19 deletion or exon 21 (L858R) substitution mutation by central laboratory or site-validated testing assay.
. No prior systemic anti-tumor therapy.
. ECOG performance status 0-2.
. Expected survival ≥12 weeks.
. Able to swallow oral study medication.
. At least one measurable lesion per RECIST 1.1 criteria.
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 (PFS)
Timeframe: Up to 48 months after the last participant enrollment,including at least 24 months of follow-up after the last participant is enrolled.
Trial details
NCT IDNCT07709585
SponsorGuangzhou University of Traditional Chinese Medicine
. Receiving other systemic anti-tumor therapy, or plan to combine other systemic anti-cancer agents during study.
. Participated in another investigational drug trial within 4 weeks prior to first study drug; major surgery within 4 weeks; unhealed wound, active ulcer or fracture; radiotherapy within 2 weeks without recovery.
. Severe cardiovascular disease: QTcF ≥450 ms or clinically significant ECG abnormality; uncontrolled hypertension (SBP\>160 mmHg or DBP\>100 mmHg); congestive heart failure, cardiomyopathy, arrhythmia requiring intervention, unstable angina, myocardial infarction, stroke or TIA within 6 months prior to treatment.
. Uncontrolled active infection including active HBV, HCV, HIV, active syphilis infection judged by investigator. Stable infection without safety risk is permitted.
. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroids, or active interstitial lung disease.
. Active hemorrhage, clinically significant hemoptysis, high thromboembolic risk or prior severe thromboembolic events unsuitable for study treatment.
. Renal dysfunction with creatinine clearance \<45 mL/min; prior intolerable toxicity to pemetrexed; severe hypersensitivity to pemetrexed or its excipients.
. Positive serum pregnancy test within 7 days before treatment, pregnant or breastfeeding women; fertile subjects refusing contraception during study and 3 months after last dose.