Non-Small Cell Lung CancerPhase 1/2NCT07362940

A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib

A Phase 1/2 study testing GEN-725 tablets + Dositinib mesylate tablets in people with Non-Small Cell Lung Cancer, run by Henan Genuine Biotech Co., Ltd. at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: GEN-725 tablets + Dositinib mesylate tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 5 sitesChina
Study dates: 27 Nov 2025to 31 Dec 2028
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to 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 subjects naive to EGFR-TKI therapy, paraffin-embedded tissue blocks, unstained slides, or fresh tumor tissue samples must be available for EGFR testing.)
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, and/or radical concurrent/sequential chemoradiotherapy (including chemotherapy, immunotherapy, targeted therapy, etc.) must have documented disease recurrence or progression within <6 months of completing the last regimen. b) Phase Ⅱa Dose Expansion Stage: Cohort 1: NSCLC patients with disease progression on a prior third-generation EGFR-TKI. Cohort 2: EGFR mutant NSCLC patients who are EGFR-TKI-naive.
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.

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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 laboratory testing):
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 are acceptable).
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 retesting results meet the criteria, they will be considered eligible.
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 treatment for intracranial metastasis for at least 14 days before enrollment. Patients with stable intracranial metastases (including newly identified intracranial metastasis that are treatment-naive) who do not require treatment are eligible. Patients with stable meningeal metastasis are eligible following confirmation by the investigator (Applicable only to dose expansion stage).
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 the investigator, women of childbearing potential in this study are defined as sexually mature women: 1) have not undergone a hysterectomy or bilateral oophorectomy; 2) have not experienced natural menopause last for 12 consecutive months (amenorrhea following cancer treatment does not preclude the possibility of fertility) (i.e., have experienced menstruation with the last 12 consecutive months). Male patients with female partners of childbearing potential must agree to use effective contraception during the study treatment and for 180 days after the last administration.
Subjects have been fully informed, have voluntarily sign the informed consent form, and are willing to comply with the study procedures and visit schedule.

Who cannot join

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 the first administration (whichever is shorter);
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;

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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 neuropathy from previous platinum-therapy is allowed up to grade 2;
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 mutation, KRAS G12C, NTRK fusion, etc. (Applicable only to the dose expansion period, and will be adjusted according to the gene detection results from the dose escalation period);
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 therapy), uncontrolled diabetes, coronary artery stenosis, aortic dissection, aortic aneurysm, active bleeding diathesis, etc.;
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 vomiting, history of major gastrointestinal resection, uncured chronic diarrhea, atrophic gastritis (age of onset <60 years), uncured gastric diseases requiring long-term use of proton pump inhibitors (e.g., omeprazole, lansoprazole, pantoprazole, rabeprazole), Crohn's disease, ulcerative colitis, etc.;
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 interval >250 msec, etc.;
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 sudden death under 40 years of age, or current use of any medication known to prolong the QT interval;
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 chronic obstructive pulmonary disease, etc.;
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 hemorrhage, myocardial infarction, etc.; with the exception of asymptomatic lacunar infarction or intramuscular venous thrombosis not requiring clinical intervention;
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 ≥500 copies/ml or above the upper limit of the normal reference range), Hepatitis C (HCV RNA above the upper limit of normal), or Human Immunodeficiency Virus (HIV antibody positive);
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 significant increase for 3 days after drainage cessation);
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 carcinomas that have been adequately treated with no evidence of recurrence (including but not limited to cervical carcinoma in situ, ductal carcinoma in situ of the breast, etc.);
Patients who have received systemic corticosteroids (>10 mg/day prednisone equivalent) or other systemic immunosuppressants (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) within 2 weeks prior to the first administration. The use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids is permitted;
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 interfere with result interpretation, and, in the investigator's judgment, make the patients unsuitable for participation in this study;
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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jun Zhou contact

010-88196456

ohjerry@163.com

City, postcode or hospital

Sites recruiting now only

5 sites in 1 country

China5 sites, 5 recruiting

Beijing Cancer Hospital
Beijing
Recruiting
Hunan Cancer Hospital
Changsha
Not yet recruiting
Cancer Hospital Affiliated to Shandong First Medical University (Shandong Cancer Hospital, Shandong cancer prevention and treatment institute)
Jinan
Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Not yet recruiting
Henan Cancer Hospital
Zhengzhou
Not yet recruiting

Other trials in China

About this study

Official title: A Phase Ⅰ/Ⅱa Clinical Study Evaluating the Efficacy and Safety of GEN-725 in Combination With Dositinib in Patients With Locally Advanced or Metastatic EGFR-Mutant Non-small Cell Lung Cancer

Conditions: Non-Small Cell Lung Cancer
Being tested: GEN-725 tablets + Dositinib mesylate tablets
Keywords: Non-Small Cell Lung Cancer, EGFR mutation, GEN -725, Dositinib
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GEN-725 tablets + Dositinib mesylate tabletsDrug
Dose-escalation part (Phase Ⅰ): Subjects will receive once-daily oral administration of GEN-725 tablets in combination with Dositinib mesylate tablets on an empty stomach. GEN-725 will be administered at a dose of 6 mg or 9 mg, and Dositinib will be administered at a dose of 80 mg or 160 mg. Both drugs should be taken concurrently. The treatment will continue until the first occurrence of any of the following: disease progression, unacceptable toxicity, withdrawal of consent, or investigator's determination of no further clinical benefit.
Dose-expansion part (Phase Ⅱa): Subjects will receive once-daily oral administration of GEN-725 tablets in combination with Dositinib mesylate tablets or Dositinib mesylate tablets alone on an empty stomach. The dose will be selected based on the outcome of dose-escalation phase. The treatment will continue until the first occurrence of any criterion that was specified in the dose-escalation part.

Study groups in NCT07362940
Study group	Role	What they receive
Experimental	Experimental	Dose-escalation part and dose-expansion part Receives: Drug: GEN-725 tablets + Dositinib mesylate tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects with Dose Limiting Toxicity (DLT) in Phase Ⅰ
Measured: From Day 1 to Day 21 of Cycle1 (each cycle is 21 days).
Incidence and severity of adverse events (AEs) in Phase Ⅰ and Phase Ⅱa
AEs are assessed based on NCI CTCAE v5.0.
Measured: From the time of informed consent until 28 days after the last administration of the study drugs.
Objective Response Rate (ORR) in Phase Ⅱa
Measured: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Intracranial Objective Response Rate (iORR) in Phase Ⅱa
Measured: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.

Secondary outcomes (11)

Objective Response Rate (ORR) in Phase Ⅰ
Measured: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Disease Control Rate (DCR) in Phase Ⅰ and Phase Ⅱa
Measured: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Progression-Free Survival (PFS) in Phase Ⅰ and Phase Ⅱa
Measured: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Duration of Response (DOR) in Phase Ⅰ and Phase Ⅱa
Measured: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Overall Survival (OS) in Phase Ⅰ and Phase Ⅱa
Measured: Every 12 weeks after the last dose, up to 5 years, up to 5 years.
Intracranial Progression-Free Survival (iPFS) in Phase Ⅱa
Measured: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Intracranial Disease Control Rate (iDCR) in Phase Ⅱa
Measured: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Intracranial Duration of Response (iDOR) in Phase Ⅱa
Measured: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Maximum Plasma Concentration (Cmax) of GEN-725 and Dositinib
Measured: Up to 24 hours post-dose.
Elimination Half-Life (t1/2) of GEN-725 and Dositinib
Measured: Up to 24 hours post-dose.
Area Under the Plasma Concentration Curve (AUC) of GEN-725 and Dositinib
Measured: Up to 24 hours post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 202531 Dec 2028

First posted23 Jan 2026
Study start27 Nov 2025
Primary completion31 Jul 2027 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 110 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07362940
Sponsor's protocol ID: Dox-RC001
Status last verified: Nov 2025
First submitted: 24 Dec 2025
Last updated: 23 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ⅰ/Ⅱa Clinical Study Evaluating the Efficacy and Safety of GEN-725 in Combination With Dositinib in Patients With Locally Advanced or Metastatic EGFR-Mutant Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07362940
Acronym / sponsor ID: Dox-RC001
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer, EGFR mutation, GEN -725, Dositinib
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 110 participants (estimated)
Lead sponsor: Henan Genuine Biotech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 27 Nov 2025 (actual)
Primary completion: 31 Jul 2027 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 23 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental	Experimental	Drug: GEN-725 tablets + Dositinib mesylate tabletsDose-escalation part and dose-expansion part

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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 subjects naive to EGFR-TKI therapy, paraffin-embedded tissue blocks, unstained slides, or fresh tumor tissue samples must be available for EGFR testing.)
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, and/or radical concurrent/sequential chemoradiotherapy (including chemotherapy, immunotherapy, targeted therapy, etc.) must have documented disease recurrence or progression within <6 months of completing the last regimen. b) Phase Ⅱa Dose Expansion Stage: Cohort 1: NSCLC patients with disease progression on a prior third-generation EGFR-TKI. Cohort 2: EGFR mutant NSCLC patients who are EGFR-TKI-naive.
Patients with at least one measurable or evaluable lesion per RECIST 1.1 criteria.

Key exclusion criteria (30 listed)

Patients have previously received any of the following treatments:
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 neuropathy from previous platinum-therapy is allowed up to grade 2;
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 mutation, KRAS G12C, NTRK fusion, etc. (Applicable only to the dose expansion period, and will be adjusted according to the gene detection results from the dose escalation period);
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 therapy), uncontrolled diabetes, coronary artery stenosis, aortic dissection, aortic aneurysm, active bleeding diathesis, etc.;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GEN-725 tablets + Dositinib mesylate tabletsDose-escalation part (Phase Ⅰ): Subjects will receive once-daily oral administration of GEN-725 tablets in combination with Dositinib mesylate tablets on an empty stomach. GEN-725 will be administered at a dose of 6 mg or 9 mg, and Dositinib will be administered at a dose of 80 mg or 160 mg. Both drugs should be taken concurrently. The treatment will continue until the first occurrence of any of the following: disease progression, unacceptable toxicity, withdrawal of consent, or investigator's determination of no further clinical benefit. Dose-expansion part (Phase Ⅱa): Subjects will receive once-daily oral administration of GEN-725 tablets in combination with Dositinib mesylate tablets or Dositinib mesylate tablets alone on an empty stomach. The dose will be selected based on the outcome of dose-escalation phase. The treatment will continue until the first occurrence of any criterion that was specified in the dose-escalation part.	Drug	Experimental

Primary outcome

Number of Subjects with Dose Limiting Toxicity (DLT) in Phase Ⅰ
Time frame: From Day 1 to Day 21 of Cycle1 (each cycle is 21 days).
Incidence and severity of adverse events (AEs) in Phase Ⅰ and Phase Ⅱa
Time frame: From the time of informed consent until 28 days after the last administration of the study drugs.
AEs are assessed based on NCI CTCAE v5.0.
Objective Response Rate (ORR) in Phase Ⅱa
Time frame: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Intracranial Objective Response Rate (iORR) in Phase Ⅱa
Time frame: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.

11 secondary outcomes

Objective Response Rate (ORR) in Phase Ⅰ
Time frame: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Disease Control Rate (DCR) in Phase Ⅰ and Phase Ⅱa
Time frame: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Progression-Free Survival (PFS) in Phase Ⅰ and Phase Ⅱa
Time frame: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Duration of Response (DOR) in Phase Ⅰ and Phase Ⅱa
Time frame: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Overall Survival (OS) in Phase Ⅰ and Phase Ⅱa
Time frame: Every 12 weeks after the last dose, up to 5 years, up to 5 years.
Intracranial Progression-Free Survival (iPFS) in Phase Ⅱa
Time frame: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Intracranial Disease Control Rate (iDCR) in Phase Ⅱa
Time frame: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Intracranial Duration of Response (iDOR) in Phase Ⅱa
Time frame: Every 6 weeks during the first year and every 12 weeks thereafter, up to 5 years.
Maximum Plasma Concentration (Cmax) of GEN-725 and Dositinib
Time frame: Up to 24 hours post-dose.
Elimination Half-Life (t1/2) of GEN-725 and Dositinib
Time frame: Up to 24 hours post-dose.
Area Under the Plasma Concentration Curve (AUC) of GEN-725 and Dositinib
Time frame: Up to 24 hours post-dose.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jun Zhou contact

010-88196456

ohjerry@163.com

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GEN-725 tablets + Dositinib mesylate tablets in people with Non-Small Cell Lung Cancer, run by Henan Genuine Biotech Co., Ltd. at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jun Zhou (010-88196456, ohjerry@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects with Dose Limiting Toxicity (DLT) in Phase Ⅰ (time frame: From Day 1 to Day 21 of Cycle1 (each cycle is 21 days).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07362940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.