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 (May 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
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.
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