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

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.

Trial Details

NCT ID
NCT07231068
Phase
PHASE1 / PHASE2
Sponsor
Henan Genuine Biotech Co., Ltd.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Dositinib mesylate tablets
Locations (sample)
  • Beijing, China|39.9075,116.39723
  • Beijing, China|39.9075,116.39723
  • Guangzhou, China|23.11667,113.25
  • Zhengzhou, China|34.75778,113.64861
  • Zhengzhou, China|34.75778,113.64861

Key Eligibility Criteria

  • 18-75 years old (including 18 and 75 years old), male or female.
  • Histologically or cytologically confirmed patients with locally advanced NSCLC (stage IIIB / IIIc) or metastatic NSCLC (stage IV) who are unable to…
  • Locally advanced or metastatic NSCLC patients who have documentation of disease progression (with imaging evidence) while on previous continuous tr…
  • Patients with confirmed EGFR activating mutations that are sensitive to EGFR TKI at any time after initial diagnosis, in dose escalation part inclu…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Non-Small Cell (NSCLC) Lung Cancer Trials on Trialify →