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

Recruiting Phase 3 Interventional Study
Non-small Cell Lung Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
576 (estimated)
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender. 2. Subjects with histologically or cytologically confirmed locally advanced, metastatic, or recurrent non-small cell lung cancer, with EGFR mutations confirmed by tissue or blood spe…
Contacts

Jun Liu

0518-82342973

jun.liu@hengrui.com

CONTACT