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

Phase 3RecruitingNCT06430437

Jiangsu HengRui Medicine Co., Ltd.300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Non-Small Cell Lung Cancer With HER2- Mutations

Interventions

SHR-A1811DRUG

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

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

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: Until progression, assessed up to approximately 2 years

Secondary Outcomes

Overall Survival (OS)

Defined as time from randomization until the date of death due to any cause

Time frame: Until death, assessed up to approximately 3 years

Progression Free Survival (PFS) by investigator assessment

Defined as time from randomization until progression per RECIST 1.1 as assessed by the investigator

Time frame: Until progression, assessed up to approximately 2 years

Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)

Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame: until to 90 days after the last dose，assessed up to approximately 3 years

Central Contacts

You Li

CONTACT

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

Data from ClinicalTrials.gov

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