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NCT06362980

A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations

An Open-label, Single-arm, Investigator-initiated Phase I Clinical Study Evaluating BPI-1178 Capsules in Combination With Osimertinib Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With EGFR Mutations
National Cancer Center, China·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
NSCLC
Drug/Device/Intervention
BPI-1178
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
National Cancer Center, China
Timeline & enrollment
Phase
Phase 1
Start date
Apr 01, 2024
End date
Apr 01, 2026
Enrollment
20 participants
Primary outcome

Number of patients with dose-limiting toxicity (DLT)

Summary

BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4)
 and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study
 was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with
 osimertinib in patients with locally advanced or metastatic non-small cell lung cancer
 (NSCLC) and epidermal growth factor receptor (EGFR) Mutations.

Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06362980
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06362980 through Pure Global AI's free database. This Phase 1 trial is sponsored by National Cancer Center, China and is currently Not yet recruiting. The study focuses on NSCLC. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.