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

January 18, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
        • Principal Investigator:
          • Shun Lu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Able and willing to provide a written informed consent
  2. 18-75 years old (inclusive of both ends)
  3. ECOG score of 0 or 1.
  4. Patients with histologically or cytologically confirmed advanced or metastatic NSCLC.
  5. Subjects with central laboratory- confirmed functional HER2 mutations
  6. No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC.
  7. Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1
  8. Protocol-defined adequate organ function including cardiac, renal, hepatic function

Exclusion Criteria:

  1. Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology.
  2. Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release.
  3. Subjects with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis.
  4. With poorly controlled tumor-related pain.
  5. previous or current with other malignancies.
  6. Subjects with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious pneumonia.
  7. Subjects with active or previous autoimmune diseases.
  8. Subjects with uncontrolled or severe cardiovascular diseases.
  9. Subjects with active hepatitis B or hepatitis C.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-A1811
Drug: SHR-A1811
Drug: SHR-A1811 administered intravenously every 3 weeks (Q3W)
Active Comparator: Standard of Care（PD-1/ PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin）
Drug: PD-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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) based on blinded independent central review (BICR)
Time Frame: Until progression, assessed up to approximately 2 years
Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)
Until progression, assessed up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Until death, assessed up to approximately 3 years
Defined as time from randomization until the date of death due to any cause
Until death, assessed up to approximately 3 years
Progression Free Survival (PFS) by investigator assessment
Time Frame: Until progression, assessed up to approximately 2 years
Defined as time from randomization until progression per RECIST 1.1 as assessed by the investigator
Until progression, assessed up to approximately 2 years
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Time Frame: until to 90 days after the last dose，assessed up to approximately 3 years
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
until to 90 days after the last dose，assessed up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

May 24, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-A1811-310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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