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Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC

NCT05209256 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-01-26

No results posted yet for this study

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 .

Conditions

Interventions

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Henan University of Science and Technology

    lead OTHER

Principal Investigators

  • Xinshuai Wang, PHD · The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology

  • Guoqiang Kong, MD · The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology

  • Xiaozhi Yuan, MD · The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology

  • Jing Ren, MD · The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-01-31
Completion
2025-01-31

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05209256 on ClinicalTrials.gov