Actively Recruiting
A Dose-escalation and Dose-expansion Phase I/Phase II Clinical Study of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutation
Led by Henan Genuine Biotech Co., Ltd. · Updated on 2025-11-17
153
Participants Needed
5
Research Sites
374 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label phase I/phase II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, preliminary efficacy of Dositinib in participants of locally advanced or metastatic non-small cell lung cancer with positive EGFR mutation.
CONDITIONS
Official Title
A Dose-escalation and Dose-expansion Phase I/Phase II Clinical Study of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old, any gender
- Diagnosed with locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-small cell lung cancer
- Disease progressed during or intolerant to prior EGFR-TKI treatments (excluding third-generation EGFR TKIs) for dose escalation part
- Confirmed EGFR activating mutations sensitive to EGFR TKI (specific mutations listed for dose escalation and expansion parts)
- No prior systemic antitumor therapy for advanced NSCLC; first-line chemotherapy without TKI allowed for dose expansion part
- At least one measurable or evaluable lesion by imaging (CT or MRI), with specific intracranial lesion requirements for certain dose groups
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ functions including specified blood counts, liver enzymes, bilirubin, coagulation, and kidney function
- Negative pregnancy test and agreement to use contraception for females of childbearing potential
- Signed informed consent form
You will not qualify if you...
- Used chemotherapy, immunotherapy, major surgery, or radiotherapy within 28 days before first study drug dose
- Use of third-generation EGFR TKI drugs prior to study
- Participation in other therapeutic clinical trials within one month before first study drug dose
- Use of CYP3A4 strong inhibitors or inducers or anti-tumor Chinese herbal medicines
- Unrecovered adverse events from prior antitumor treatments (except alopecia)
- Other cancers within 5 years except certain treated skin or in situ cancers
- Conditions affecting drug swallowing or absorption
- History of organ transplantation
- Significant cardiac abnormalities or risks for QT prolongation
- History or active interstitial lung disease or active tuberculosis
- Poor lung function tests below specified thresholds
- Symptomatic or untreated brain metastases, spinal cord compression, or meningeal metastasis
- Hypersensitivity to study drug or similar compounds
- EGFR 20 exon insertion mutations
- Acute infection requiring medical treatment
- Active hepatitis B or C infection
- HIV positive status
- History of mental disorders under treatment
- History of drug abuse
- Pregnancy or lactation
- Inability to use effective contraception during study and 90 days after
- Any other conditions or factors judged by the researcher to interfere with study participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
2
Peking Union Medical College Hospital
Beijing, China
Withdrawn
3
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Actively Recruiting
4
Henan Provincial Cancer Hospital
Zhengzhou, China
Actively Recruiting
5
Henan Provincial People's Hospital
Zhengzhou, China
Actively Recruiting
Research Team
J
Junling Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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