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A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC

NCT07183189 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2026-04-14

No results posted yet for this study

Summary

This study is a randomized, controlled, open-label, multicenter Phase III clinical trial designed to compare the efficacy and safety of SHR-A2009 combined with aumolertinib versus aumolertinib monotherapy in treatment-naïve subjects with EGFR-mutated, locally advanced or metastatic non-small cell lung cancer.

Conditions

Interventions

DRUG

SHR-A2009 ; Aumolertinib

SHR-A2009 administered intravenously, Aumolertinib administered orally.

DRUG

Aumolertinib

Aumolertinib administered orally

Sponsors & Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

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
2025-10-30
Primary Completion
2032-11-30
Completion
2032-12-31

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 NCT07183189 on ClinicalTrials.gov