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A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations - Trial NCT06362980

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.

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NCT06362980
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06362980
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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

Study Focus

NSCLC

BPI-1178

Interventional

drug

Sponsor & Location

National Cancer Center, China

Timeline & Enrollment

Phase 1

Apr 01, 2024

Apr 01, 2026

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

ClinicalTrials.gov

NCT06362980

Non-Device Trial