MedTrace Logo

A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC

NCT06671379 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2026-03-19

No results posted yet for this study

Summary

This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.

Conditions

Interventions

DRUG

SHR-A2009 monotherapy

SHR-A2009 monotherapy ，SHR-A2009 will be administered intravenously

DRUG

platinum-based dual-agent chemotherapy

Pemetrexed combined with carboplatin or cisplatin, after four cycles of combination, pemetrexed was continued as a single agent，all drugs will be administered intravenously

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
2024-11-29
Primary Completion
2026-12-31
Completion
2027-06-30

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 NCT06671379 on ClinicalTrials.gov