RecruitingPhase 3NCT06430437

A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations

A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

300 participants

Start Date

Jul 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called SHR-A1811 — an antibody-drug conjugate that targets the HER2 protein — as a first-line treatment for people with advanced or metastatic non-small cell lung cancer (NSCLC) that carries a HER2 mutation. These HER2 mutations are a driver of cancer growth in a subset of lung cancers. **You may be eligible if...** - You are between 18 and 75 years old - You have advanced or metastatic NSCLC confirmed by biopsy - Your tumor has been confirmed to carry a functional HER2 mutation by a central laboratory - You have not yet received any systemic treatment for your advanced or metastatic NSCLC - You are in generally good health (ECOG 0–1) - You have at least one measurable tumor outside the brain on imaging - Your heart, kidney, liver, and blood count results are within acceptable ranges **You may NOT be eligible if...** - Your lung cancer has a small cell component or sarcomatoid features - Your cancer also has another driver mutation that has an approved targeted therapy available - You have active or untreated brain or spinal cord metastases - You have poorly controlled pain from the tumor - You have had or currently have another cancer - You have a history of serious lung inflammation or pneumonitis 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-A1811

Drug: SHR-A1811 administered intravenously every 3 weeks (Q3W)

DRUGPD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin

Drug: PD-1/PD-L1 inhibitors administered intravenously every 3 weeks (Q3W) Drug: Pemetrexed Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Paclitaxel Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Carboplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Cisplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W)


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT06430437