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Almonertinib Vs. Erlotinib/Chemotherapy for Neo-adjuVant Treatment of Stage IIIA-N2 EGFR-mutated NSCLC

NCT04455594 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2020-07-02

No results posted yet for this study

Summary

This is a multicenter, randomized, controlled, phase II study assessing the efficacy and safety of Almonertinib compared Erlotinib or platinum doublet chemotherapy (carboplatin or cisplatin + pemetrexed) as neoadjuvant therapy to EGFRm+ IIIA-N2 NSCLC patients.

Conditions

  • Non-Small Cell Lung Cancer Stage IIIA

Interventions

DRUG

Almonertinib

Oral, 110mg QD

DRUG

Erlotinib

Oral, 150mg QD

DRUG

Cisplatin

Cisplatin(75mg/m2) be administered with pemetrexed (500mg/m2) on Day 1 of every 3-week cycle for 3 cycles

DRUG

Carboplatin

Carboplatin (AUC=5) to be administered with pemetrexed (500mg/m2) on Day 1 of every 3-week cycle for 3 cycles

DRUG

Pemetrexed

Pemetrexed (500mg/m2) to be administered with Cisplatin(75mg/m2) or Carboplatin (AUC=5) on Day 1 of every 3-week cycle for 3 cycles

Sponsors & Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

    lead OTHER

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
2020-10-31
Primary Completion
2023-01-31
Completion
2025-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04455594 on ClinicalTrials.gov