## Protocol Section
### Identification Module
**NCT ID:** NCT06430437

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

**Official 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

#### Organization Study ID Info
**ID:** SHR-A1811-310
#### Organization
**Class:** INDUSTRY
**Full Name:** Jiangsu HengRui Medicine Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2027-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Jiangsu HengRui Medicine Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Non-Small Cell Lung Cancer With HER2- Mutations

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: SHR-A1811

**Label:** SHR-A1811

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin

**Label:** Standard of Care（Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin）

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SHR-A1811

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

**Name:** SHR-A1811

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Standard of Care（Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin）

**Description:** Drug: Camrelizumab 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)

**Name:** Camrelizumab、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)

**Measure:** Progression-free survival (PFS) based on blinded independent central review (BICR)

**Time Frame:** Until progression, assessed up to approximately 2 years

#### Secondary Outcomes

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

**Measure:** Overall Survival (OS)

**Time Frame:** Until death, assessed up to approximately 3 years

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

**Measure:** Progression Free Survival (PFS) by investigator assessment

**Time Frame:** Until progression, assessed up to approximately 2 years

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

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** you.li.yl1@hengrui.com

**Name:** You Li

**Phone:** 0518-81220121

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Name:** Shun Lu

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Shanghai Chest Hospital

**State:** Shanghai

**Zip:** 200030

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: HIGH

- As Found: Non-Small Cell Lung Cancer

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

### Intervention Browse Module - Ancestors

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000005493

- Term: Folic Acid Antagonists

- ID: D000019384

- Term: Nucleic Acid Synthesis Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M18650

- Name: Carboplatin

- Relevance: HIGH

- As Found: System

- ID: M264

- Name: Pemetrexed

- Relevance: HIGH

- As Found: Strategies

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M6182

- Name: Cisplatin

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M8619

- Name: Folic Acid Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: T447

- Name: Folinic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017239

- Term: Paclitaxel

- ID: D000016190

- Term: Carboplatin

- ID: D000068437

- Term: Pemetrexed

### Misc Info Module

- Version Holder: 2024-05-31
