Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04001777

A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients

EGFR Positive Non-small Cell Lung Cancer Clinical Trial

Official title:
A Phase Ib Study of Safety and Efficacy of APG-1252 in Combination With Osimertinib (AZD9291) in EGFR TKI Resistant NSCLC Patients

Clinical Trial Summary

There are unmet medical needs in patients who resist to EGFR TKIs, especially to osimertinib; APG-1252 shows synergy with osimertinib in both osimertinib treatment naïve and resistant cell lines. This study is to explore the safety and efficacy of the combination of APG-1252 and osimertinib in 3rd generation TKI resistant patients and 3rd generation TKI treatment naïve patients.

Clinical Trial Description

This is a multi-center, open-label, Phase 1b study evaluating the adverse events and best dose of the combination of fixed dose AZD9291 with APG-1252 in EGFR-TKI resistant NSCLC patients. In exploration phase, 3+3 design will be used to determine the MTD/RP2D of the combination of AZD9291 with APG-1252; Dose of AZD9291 will be fixed at 80mg QD, APG-1252 will start with 240mg weekly, then escalate to 320mg weekly and 400mg weekly or decline to 160mg weekly and 80weekly if not tolerate to 240mg weekly dosage. In expansion phase, IF 1 confirmed PR or CR observed in NSCLC patients who failed 3rd generation EGFR TKI, the exploration of the combination of AZD9291 with APG-1252 in 3rd generation EGFR TKI naïve NSCLC patients will be initiated. After completing the enrollment of these two cohorts, a new cohort was added: to explore the preliminary efficacy of APG-1252 combined with osimertinib in the treatment of EGFR Exon20 Insertion or other rare mutant NSCLC patients, and enroll 20 subjects. Patients will be treated in 21-day cycles. APG-1252 administered via intravenous infusion for 30 minutes weekly (,Day 1, 8 15), AZD9291 via oral daily with 80mg. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04001777
Study type Interventional
Source Ascentage Pharma Group Inc.
Contact Yifan Zhai, MD
Phone +86-20-28069260
Email yzhai@ascentagepharma.com
Status Recruiting
Phase Phase 1
Start date July 4, 2019
Completion date June 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT02125240 - Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma Phase 3
Active, not recruiting NCT04027647 - Phase 2 Study of Dacomitinib in NSCLC Phase 2
Not yet recruiting NCT04643847 - A Phase II Trial of Upfront Radiotherapy Plus Almonertinib for Epidermal Growth Factor Receptor(EGFR)-Mutant Non-small-cell Lung Cancer(NSCLC) Patients With Brain Metastases Phase 2
Active, not recruiting NCT03126799 - A Study of Tarceva vs. Avastin+Tarceva for Advanced NSCLC With EGFR m(+) Phase 2
Recruiting NCT04900935 - Patient-centered, Optimal Integration of Survivorship and Palliative Care N/A
Not yet recruiting NCT02788058 - A Study of Hypofractionated Radiotherapy for Limited Metastatic NSCLC Harboring Sensitizing EGFR Mutations After First Line TKI Therapy Phase 2
Recruiting NCT02103257 - Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma Phase 4
Recruiting NCT05338619 - A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stage III) Following Chemoradiation Therapy Phase 2
Recruiting NCT05037331 - Osimertinib for Advanced EGFR-positive NSCLC Patients
Active, not recruiting NCT02194556 - Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC Phase 4
Active, not recruiting NCT03382795 - Retreatment With Epidermal Growth Factor Receptor(EGFR) Tyrosine Kinase Inhibitor in EGFR Mutation Positive Patients Phase 2
Recruiting NCT05089916 - Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study Phase 2
Not yet recruiting NCT06208033 - SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC) Early Phase 1
Completed NCT02729298 - First-in-human Study of Oral TP-0903 (a Novel Inhibitor of AXL Kinase) in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT01665417 - Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma Phase 4
Not yet recruiting NCT05962021 - Neoadjuvant Toripalimab for Non-squamous NSCLC With EGFR Mutation Phase 2
Completed NCT04105153 - Real-world Analysis of Workup at Disease Progression and Implementation of Osimertinib for EGFR+ NSCLC