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New treatment option for Non-Small Cell Lung Cancer
Official title A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib
ClinicalTrials.gov ID: NCT07362940
What this study is testing
What is GEN-725 tablets + Dositinib mesylate tablets?
GEN-725 tablets + Dositinib mesylate tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 18-75 years old (including 18 and 75 years old), male or female.
- Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not amenable to...
- Patients with a positive EGFR mutation. (For patients with prior third-generation EGFR-TKI therapy, post-progression EGFR mutation test results are...
- a) Phase Ⅰ Dose Escalation Stage: EGFR-mutant NSCLC patients who have received at least one prior line of therapy (chemotherapy or targeted therapy...
- Patients with at least one measurable or evaluable lesion per RECIST 1.1 criteria.
You likely can't join if
- Patients have previously received any of the following treatments:
- Undergone major surgery within 4 weeks prior to the first administration;
- Antitumor therapy including chemotherapy, immunotherapy, targeted therapy, etc., within 4 weeks prior to the first administration; for oral...
- Radiation therapy involving \>30% of the bone marrow or large-field radiation therapy within 4 weeks prior to the first administration;
- Strong inhibitors or inducers of CYP3A4 within 7 days prior to the first administration;
- Traditional Chinese medicine (TCM) or TCM preparations that have antitumor indications, or that are intended for tumor adjuvant therapy within 14...
See the full eligibility criteria
Who can join
- 18-75 years old (including 18 and 75 years old), male or female.
- Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not amenable to curative surgery or radiotherapy. (For people naive to EGFR-TKI therapy...
- Patients with a positive EGFR mutation. (For patients with prior third-generation EGFR-TKI therapy, post-progression EGFR mutation test results are recommended.)
- a) Phase Ⅰ Dose Escalation Stage: EGFR-mutant NSCLC patients who have received at least one prior line of therapy (chemotherapy or targeted therapy are allowed). Patients who have received prior neoadjuvant, adjuvant...
- Patients with at least one measurable or evaluable lesion per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and a life expectancy of at least 12 weeks.
- Adequate organ function must meet the following criteria (with no transfusion of blood, blood products, no administration of hematopoietic growth factors, or no infusion of albumin/blood products within 14 days before...
- Absolute neutrophil (NE) count ≥ 1.5 × 10\^9/L.
- Platelet (PLT) count ≥ 100 × 10\^9/L.
- Hemoglobin (HGB) ≥ 100 g/L.
- Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 × ULN (for patients with liver metastases, TBIL ≤ 3 × ULN and AST/ALT ≤ 5 × ULN...
- Serum creatinine (SCr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min. Note: If the investigator deems retesting necessary (with the reason documented), the above laboratory tests may be repeated only once. If the...
- Patients with stable intracranial metastatic lesions are eligible. Stable intracranial metastasis is defined as: stable signs and symptoms for at least 2 weeks before enrollment, and discontinuation of corticosteroid...
- Women of childbearing potential must have a negative blood pregnancy test and agree to use effective contraception during the study treatment and for 180 days after the last administration. According to the judgment of...
- people have been fully informed, have voluntarily sign the informed consent form, and are willing to comply with the study procedures and visit schedule.
What rules you out
- Patients have previously received any of the following treatments:
- Undergone major surgery within 4 weeks prior to the first administration;
- Antitumor therapy including chemotherapy, immunotherapy, targeted therapy, etc., within 4 weeks prior to the first administration; for oral small-molecule targeted drugs, within 2 weeks or within 5 half-lives prior to...
- Radiation therapy involving \>30% of the bone marrow or large-field radiation therapy within 4 weeks prior to the first administration;
- Strong inhibitors or inducers of CYP3A4 within 7 days prior to the first administration;
- Traditional Chinese medicine (TCM) or TCM preparations that have antitumor indications, or that are intended for tumor adjuvant therapy within 14 days prior to the first administration;
- Presence of unresolved toxicities from previous anticancer therapy, with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade \>1 (except alopecia) at the start of study treatment. The pre-existing...
- Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: MET exon 14 skipping mutation, MET amplification, ALK fusion, HER-2 mutation, ROS-1 fusion, RET fusion, BRAF V600E...
- Patients with disease progression (PD) or stable disease (SD) with a duration of ≤3 months following treatment with a third-generation EGFR-TKI;
- Patients with any uncontrolled systemic disease, as determined by the investigator, such as uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg after optimal medical...
- Patients with any clinically significant gastrointestinal condition that could impair the intake, transport, or absorption of the study drug, such as inability to take oral medication, uncontrollable nausea and...
- Patients meeting any of the following cardiac criteria:
- Mean corrected QT interval (QTc) \>470 msec based on resting electrocardiogram (ECG);
- Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG, such as complete left bundle branch block, Ⅲ degree atrioventricular block, Ⅱ degree atrioventricular block, or PR...
- Congestive heart failure classified as New York Heart Association (NYHA) Class III-IV, or poorly controlled and clinically significant arrhythmias;
- Any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome in first-degree relatives or unexplained...
- Left ventricular ejection fraction (LVEF) \<50% as measured by echocardiography;
- Patients with interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment; or those with suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging during screening;
- Patients with concurrent pulmonary disease resulting in clinically severe respiratory impairment, including but not limited to: severe pulmonary embolism within 3 months prior to the first dose, severe asthma, or severe...
- Patients with a history of significant arterial/venous thrombotic events or cerebrovascular accidents within 6 months prior to the first administration, such as pulmonary embolism, cerebral infarction, cerebral...
- Patients with concurrent use of therapeutic doses of anticoagulants such as vitamin K antagonists or heparin (patients using prophylactic doses are eligible);
- Patients with an active systemic infection: Tuberculosis (clinical diagnosis including history, physical examination, radiographic findings, and TB testing per local practice), Hepatitis B (HBsAg positive and HBV DNA...
- Patients with clinically uncontrolled pleural effusion/ascites/pericardial effusion within 2 weeks prior to the first administration. (Patients are eligible if the effusion does not require drainage or has shown no...
- Patients with a history of other malignancies within 5 years prior to the first administration, except for: adequately treated papillary thyroid carcinoma, basal cell or squamous cell skin cancer, or other in situ...
- Patients who have received systemic corticosteroids (\>10 mg/day prednisone equivalent) or other systemic immunosuppressants (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine...
- Patients with a history of psychiatric disorders or substance abuse that may impair compliance with trial requirements;
- Patients with a history of other acquired or congenital immunodeficiency diseases, or those who have undergone or are scheduled for organ transplantation or bone marrow transplantation;
- Patients with a history of hypersensitivity to the active ingredient or any excipients of the study drug, or to any drug of a similar chemical structures or pharmacological class;
- Patients with any other acute or chronic medical conditions, psychiatric conditions, or abnormal laboratory findings that may increase the risk associated with study participation or study drug administration, or...
- Patients who are unlikely to comply with the study protocol, or in the investigator's opinion, the patient is unsuitable for participation in this clinical study due to other reason.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changsha, China
- Jinan, China
- Xiamen, China
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Changsha, China; Jinan, China; Xiamen, China; Zhengzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.