Recruiting

NCT Number: NCT06430437

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

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

Recruiting

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Key information

Conditions

Non-Small Cell Lung Cancer With HER2- Mutations

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location status: Recruiting

Location contact

Shun Lu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

SHR-A1811

Drug

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

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

Drug

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)

Primary outcomes

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)

Secondary outcomes

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
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
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

Study contacts

Contact information is provided by the study sponsor or research team.

You Li

CONTACT

[email protected]

0518-81220121

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: May 28, 2024
Registry last updated: Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.