Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Henan University of Science and Technology
• Treatments: Pemetrexed

Criteria

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.