RecruitingPhase 1Phase 2NCT05482568

A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer

Phase IB/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer With HER2

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

324 participants

Start Date

Sep 15, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced Non-Small Cell Lung Cancer

Summary

This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316 for people with advanced non-small cell lung cancer. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 75 Years.

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 & Pyrotinib/SHR-A1811 & SHR-1316

Drug: SHR-A1811 \& Pyrotinib SHR-A1811： intravenous Pyrotinib：oral Drug: SHR-A1811 \& SHR-1316 SHR-A1811： intravenous SHR-1316： intravenous

Locations(2)

Shanghai Chest hospital

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT05482568

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