OncoMatch/Clinical Trials/NCT07362940
A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib
Is NCT07362940 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07362940 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antitumor therapy, radiation therapy disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR mutation is a required biomarker for enrollment.
Are patients with MET alterations eligible?
No. MET exon 14 skipping mutation is an exclusion criterion.
Are patients with MET alterations eligible?
No. MET amplification is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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