RecruitingPhase 3NCT06671379

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

A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy


Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

500 participants

Start Date

Nov 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new targeted drug called SHR-A2009 to standard platinum-based chemotherapy in patients with advanced lung cancer that has a specific gene mutation (EGFR). SHR-A2009 is a type of antibody-drug conjugate, meaning it delivers chemotherapy directly to cancer cells. **You may be eligible if...** - You are 18 to 75 years old - You have advanced or metastatic non-small cell lung cancer (non-squamous type) confirmed by biopsy - Your cancer has an EGFR mutation and has already been treated with an EGFR-targeting pill (called a TKI) - Your cancer has at least one measurable tumor on scans - Your general health score (ECOG) is 0 or 1 **You may NOT be eligible if...** - Your cancer has spread to and is actively causing symptoms in the brain - You received chemotherapy or other cancer treatments within the past 4 weeks - Your organs (liver, kidneys, heart) are not functioning well enough Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-A2009 monotherapy

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

DRUGplatinum-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


Locations(1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

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NCT06671379


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