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

Phase 3

Recruiting

• Conditions: Non-Small Cell Lung Cancer With HER2- Mutations
• Interventions: Drug: Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin; Drug: SHR-A1811

• Registration Number: NCT06430437
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-24
• Study First Posted: 2024-05-28
• Study Start: 2024-07-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-02
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care（Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin）	Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin	-
SHR-A1811	SHR-A1811	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) based on blinded independent central review (BICR)	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 Outcome Measures

Name	Time	Method
Overall Survival (OS)	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	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)	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

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China