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Aumolertinib with or Without Chemotherapy As 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing EGFR Mutations

NCT04923906 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2024-11-25

No results posted yet for this study

Summary

To assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+).

Conditions

Interventions

DRUG

Aumolertinib

Aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of every 21-day cycles up to 4\~6 cycles, followed by Aumolertinib 100mg QD with pemetrexed maintenance (500 mg/m2) on Day 1 of every 21-day cycles. Dose may be reduced to allow for the management of investigational drug related toxicity.

DRUG

Placebo Aumolertinib

Placebo Aumolertinib 110 mg QD Dose may be reduced to allow for the management of investigational drug related toxicity.

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shun Lu, MD · Shanghai Chest Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-11
Primary Completion
2024-06-18
Completion
2026-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04923906 on ClinicalTrials.gov