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

NCT06430437 | Recruiting Phase 3

• 1 other identifier: SHR-A1811-310
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Non-Small Cell Lung Cancer With HER2- Mutations

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) based on blinded independent central review (BICR)

  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 Outcomes (3)

• Overall Survival (OS)

  Until death, assessed up to approximately 3 years

• Progression Free Survival (PFS) by investigator assessment

  Until progression, assessed up to approximately 2 years

• 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

Study Arms (2)

SHR-A1811

EXPERIMENTAL

Drug: SHR-A1811

Standard of Care（PD-1/ PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin）

ACTIVE COMPARATOR

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

Interventions

SHR-A1811 DRUG

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

SHR-A1811

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)

Standard of Care（PD-1/ PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Interventions

CP protocol; Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

You Li

CONTACT

0518-81220121; you.li.yl1@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: July 29, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2025-02

Locations

CN (1)