Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC

Phase 2

Not yet recruiting

• Conditions: NSCLC
• Interventions: Drug: Alflutinib plus chemotherapy; Drug: Chemotherapy

• Registration Number: NCT05209256
• Lead Sponsor: The First Affiliated Hospital of Henan University of Science and Technology

Brief 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.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2022-01-09
• Study First Submitted QC: 2022-01-25
• Last Update Submitted: 2022-01-25
• Study First Posted: 2022-01-26
• Last Update Posted: 2022-01-26
• Study Start: 2022-03-01
• Primary Completion: 2024-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• histologically or cytologically diagnosed non-squamous NSCLC of stage IIIB or IV (based on the 7th edition of the TNM classification) or recurrent;
• an EGFR mutation, including an exon-19 deletion (Ex19del), L858R, or other (L861Q, G719A, G719C, or G719S), as well as the T790M mutation of EGFR as detected in a tissue or liquid biopsy sample obtained after disease progression during first-line EGFR-TKI (gefitinib, erlotinib, or afatinib) treatment;
• WHO performance status of 0 or 1;
• no prior neoadjuvant or adjuvant chemotherapy in the 12 months preceding study enrollment;
• adequate bone marrow reserve and organ function.

Exclusion Criteria

• treatment with an EGFR-TKI within 7 days of the first dose of the study treatment;
• symptomatic CNS metastases;
• evidence of interstitial pneumonia, pulmonary fibrosis, or radiation pneumonitis requiring steroid treatment as revealed by a computed tomography (CT) scan.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alflutinib plus chemotherapy	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.
chemotherapy	Chemotherapy	arboplatin (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.

Primary Outcome Measures

Name	Time	Method
PFS	16 weeks	Disease-free survival

Secondary Outcome Measures

Name	Time	Method
Objective remission rate (ORR)	16 weeks	Objective remission rate
Disease Control Rate ( DCR)	16 weeks	Disease Control Rate