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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Befotertinib plus chemo with MRD-guided escalation for EGFR-mutant NSCLC

Official title: Befotertinib Plus Chemotherapy With an MRD-guided Adaptive Strategy for Treatment Escalation and Response Optimization in EGFR-mutated NSCLC Patients

Run by Guangzhou University of Traditional Chinese Medicine · NCT07709585 · Data updated 2026-11-12

This phase 2 trial tests whether starting befotertinib and then using MRD results to guide adding chemotherapy improves outcomes for adults with EGFR-mutant advanced NSCLC.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment124 (estimated)
SponsorGuangzhou University of Traditional Chinese Medicine
Academic / other
Drugs / interventionsbefotertinib, radiation, chemotherapy
Locations2 sites (Guangzhou, Guangdong and 1 other locations)
StatusRecruiting
StartedNovember 30, 2026
Main results expectedJuly 31, 2030
Study endsJuly 31, 2030
Registry record updatedNovember 4, 2026
Trial IDNCT07709585 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with untreated, stage IIIB-IV EGFR-mutant NSCLC (Exon 19 deletion or Exon 21 L858R), ECOG 0-2, measurable disease, and adequate organ function.

Probably not a fit

Patients whose disease does not respond to befotertinib or who do not achieve MRD-guided benefit may not receive improved outcomes.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter phase II study, untreated patients with advanced EGFR-mutant NSCLC receive befotertinib alone for 3 weeks, after which MRD testing guides subsequent treatment. Patients with positive MRD receive four cycles of pemetrexed plus platinum, while MRD-negative patients continue single-agent befotertinib. Maintenance therapy follows MRD status during follow-up. The study primarily looks at progression-free survival guided by dynamic MRD monitoring, with secondary endpoints including response rates, disease control, safety, and MRD clearance.

Why it matters

Potential benefit: If successful, the strategy could personalize therapy, potentially delaying chemotherapy and extending time before progression.

How similar studies have gone: MRD-guided approaches are explored in other cancers, with mixed results; this is a relatively novel application in EGFR-mutant NSCLC.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC).
2. Age ≥18 years, any gender.
3. Confirmed EGFR exon 19 deletion or exon 21 (L858R) substitution mutation by central laboratory or site-validated testing assay.
4. No prior systemic anti-tumor therapy.
5. ECOG performance status 0-2.
6. Expected survival ≥12 weeks.
7. Able to swallow oral study medication.
8. At least one measurable lesion per RECIST 1.1 criteria.
9. Adequate organ function as defined below:

   1. Absolute neutrophil count ≥1.5 × 10\^9/L;
   2. Platelet count ≥100 × 10\^9/L;
   3. Hemoglobin ≥9 g/dL (transfusion allowed);
   4. Total bilirubin ≤1.5 × ULN;
   5. ALT/AST ≤2.5 × ULN (≤5 × ULN if liver metastasis);
   6. Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥45 mL/min by Cockcroft-Gault formula if creatinine \>1.5 × ULN.
10. Fertile men and women agree to effective contraception during study treatment and for specified time after last dose.

Exclusion Criteria:

1. Receiving other systemic anti-tumor therapy, or plan to combine other systemic anti-cancer agents during study.
2. 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.
3. 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.
4. Uncontrolled active infection including active HBV, HCV, HIV, active syphilis infection judged by investigator. Stable infection without safety risk is permitted.
5. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroids, or active interstitial lung disease.
6. Active hemorrhage, clinically significant hemoptysis, high thromboembolic risk or prior severe thromboembolic events unsuitable for study treatment.
7. Renal dysfunction with creatinine clearance \<45 mL/min; prior intolerable toxicity to pemetrexed; severe hypersensitivity to pemetrexed or its excipients.
8. 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.
9. Known severe hypersensitivity to befotertinib, cisplatin, carboplatin or their excipients.
10. Any other medical, metabolic, physical or lab abnormality that may compromise subject safety or interfere with study results per investigator judgment.

Where it's running

  • Guangdong Provincial Hospital of Traditional Chinese Medicine
    Guangzhou, Guangdong, China     Recruiting
  • Guangdong Provincial Hospital of Chinese Medicine
    Guangzhou, Guangdong, China     Not yet recruiting

Study contacts

  • Principal investigator: Xiaoshu Chai, MD — Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Study coordinator: Xiaoshu Chai, MD
  • Email: chaixiaoshu@126.com
  • Phone: +8613570301605

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Advanced Non-small Cell Lung Cancer (NSCLC) 7EGFR Exon 19 Deletion Mutation 2EGFR Exon 21 Mutation 2Befotertinib 6Guangzhou University of Traditional Chinese Medicine 7
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.