NCT05209256

Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC

Alflutinib Versus Alflutinib Plus Chemotherapy for Nonesmall Cell Lung Cancer With EGFR (T790M)- Associated Resistance to Initial EGFR Inhibitor Treatment: An Open-label, Randomised Phase 2 Clinical Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: The First Affiliated Hospital of Henan University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Aim: the aim of this study is to investigated whether the combination of alflutinib with cytotoxic chemotherapy might hold additive efficacy, as well as tolerability .

Detailed description

alflutinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that is active in the central nervous system (CNS) and which potently and selectively inhibits mutant forms of EGFR with both TKI-sensitising (activating) mutations and the T790M resistance-conferring mutation. However, resistance to alflutinib inevitably emerges. One promising strategy to further improve patient prognosis and to approach a cure is combination therapy with alflutinib and other agents such as cytotoxic chemotherapeutic drugs.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Chemotherapy	Patients in the alflutinib group received alflutinib (80 mg daily) until disease progression, unacceptable toxicity, or death.
DRUG	Alflutinib plus chemotherapy	Those in the combination group received concurrent alflutinib (80 mg daily), as well as carboplatin (area under the curve \[AUC\] of 5 on day 1) and pemetrexed (500 mg/m2 on day 1) in a 3-week cycle for up to four cycles, followed by maintenance on alflutinib and pemetrexed until disease progression, unacceptable toxicity, or death.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-01-01
• Completion: 2025-01-01
• First posted: 2022-01-26
• Last updated: 2022-01-26