OncoMatch/Clinical Trials/NCT06706713
Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer
Is NCT06706713 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies BEBT-109 Capsule for non-small cell lung cancer.
Treatment: BEBT-109 Capsule — This study is an open-label, multicenter Phase II trial, planning to enroll 200 subjects, using BEBT-109 capsules as monotherapy, aimed at evaluating the efficacy and safety of BEBT-109 capsules in subjects with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations in locally advanced or metastatic Non-Small Cell Lung Cancer （NSCLC）.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 20 insertion mutation
Written test reports confirm the occurrence of EGFR exon 20 insertion mutations
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy
failed or are intolerant to at least one systemic chemotherapy (defined as having undergone at least one platinum-based chemotherapy regimen or other chemotherapy regimen)
Cannot have received: EGFR exon 20 insertion inhibitor (Poziotinib, Tarloxotinib, TAK788, JNJ-61186372, CLN-081)
previously received drugs for EGFR exon 20 insertion mutations, such as Poziotinib, Tarloxotinib, TAK788, JNJ-61186372, CLN-081
Cannot have received: third-generation EGFR TKI (high dose) (Osimertinib, Furmonertinib, Almonertinib)
high-dose third-generation EGFR TKIs (Osimertinib > 80 mg/day, Furmonertinib > 80 mg/day, or Almonertinib > 110 mg/day, etc.)
Cannot have received: any anti-cancer treatment (cytotoxic chemotherapy, radiotherapy, immunotherapy, other biological therapies, Mitomycin, Nitrosoureas, small molecule targeted drugs)
Any other anti-cancer treatment within 4 weeks prior to the first use of the study drug (including cytotoxic chemotherapy, radiotherapy, immunotherapy, or other biological therapies; for Mitomycin or Nitrosoureas, within 6 weeks; for small molecule targeted drugs, at least 2 weeks or at least 5 half-lives from the last dose, whichever is longer)
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; PLT ≥100×10^9/L; HGB ≥80g/L
Kidney function
Creatinine ≤1.5x ULN; if >1.5x ULN, creatinine clearance must be ≥45 ml/min
Liver function
Serum total bilirubin (TBIL) ≤1.5x ULN, AST and ALT ≤2.5x ULN (for those with liver metastasis, TBIL ≤3x ULN, AST and ALT ≤5x ULN allowed)
Cardiac function
APTT ≤1.5x ULN, PT ≤1.5x ULN, INR ≤1.5x ULN; QTc from 3 ECGs ≤450 msec; no severe rhythm/conduction/morphological ECG abnormalities
Laboratory tests indicate that subjects have adequate organ function: ... a. Absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet count (PLT) ≥100×10^9/L; hemoglobin (HGB) ≥80g/L; b. Serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN (for those with liver metastasis, total bilirubin ≤3 times ULN, AST and ALT ≤5 times ULN are allowed); c. Creatinine ≤1.5 times ULN, when creatinine >1.5 times ULN, creatinine clearance must be confirmed, and creatinine clearance must be ≥45 ml/min (actual value, or calculated by the Cockcroft-Gault formula); d. Activated partial thromboplastin time (APTT) ≤1.5 times ULN, prothrombin time (PT) ≤1.5 times ULN, international normalized ratio (INR) ≤1.5 times ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06706713 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior EGFR exon 20 insertion inhibitor, third-generation EGFR TKI (high dose), any anti-cancer treatment disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR exon 20 insertion mutation is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages