OncoMatch/Clinical Trials/NCT07362940
A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib
Is NCT07362940 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies GEN-725 tablets + Dositinib mesylate tablets for non-small cell lung cancer.
Treatment: GEN-725 tablets + Dositinib mesylate tablets — This is an open-label phase I/phase II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of GEN-725 in combination with Dositinib in participants with locally advanced or metastatic EGFR-mutant non-small cell lung cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR mutation
Patients with a positive EGFR mutation
Excluded: MET exon 14 skipping mutation
Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: MET exon 14 skipping mutation
Excluded: MET amplification
Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: MET amplification
Excluded: ALK fusion
Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: ALK fusion
Excluded: HER2 (ERBB2) mutation
Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: HER-2 mutation
Excluded: ROS1 fusion
Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: ROS-1 fusion
Excluded: RET fusion
Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: RET fusion
Excluded: BRAF V600E
Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: BRAF V600E mutation
Excluded: KRAS G12C
Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: KRAS G12C
Excluded: NTRK1 fusion
Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: NTRK fusion
Excluded: NTRK2 fusion
Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: NTRK fusion
Excluded: NTRK3 fusion
Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: NTRK fusion
Disease stage
Metastatic disease required
locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not amenable to curative surgery or radiotherapy
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy
EGFR-mutant NSCLC patients who have received at least one prior line of therapy (chemotherapy or targeted therapy are allowed)
Must have received: targeted therapy
EGFR-mutant NSCLC patients who have received at least one prior line of therapy (chemotherapy or targeted therapy are allowed)
Cannot have received: antitumor therapy
Exception: oral small-molecule targeted drugs within 2 weeks or within 5 half-lives prior to the first administration (whichever is shorter)
Antitumor therapy including chemotherapy, immunotherapy, targeted therapy, etc., within 4 weeks prior to the first administration
Cannot have received: radiation therapy
Exception: large-field radiation therapy within 4 weeks prior to the first administration
Radiation therapy involving >30% of the bone marrow or large-field radiation therapy within 4 weeks prior to the first administration
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 100 g/L
Kidney function
Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min
Liver function
Serum total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN (for patients with liver metastases, TBIL ≤ 3 × ULN and AST/ALT ≤ 5 × ULN are acceptable)
Cardiac function
Mean corrected QT interval (QTc) >470 msec, clinically significant ECG abnormalities, NYHA Class III-IV heart failure, poorly controlled arrhythmias, LVEF <50%
Adequate organ function must meet the following criteria...cardiac criteria: Mean corrected QT interval (QTc) >470 msec...LVEF <50% as measured by echocardiography
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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