## Protocol Section
### Identification Module
**NCT ID:** NCT06434103

**Brief Title:** Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC

**Official Title:** An Open, Multicenter Phase I/II Trial of SHR-A1921 in Combination With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC

#### Organization Study ID Info
**ID:** SHR-A1921-205
#### Organization
**Class:** INDUSTRY
**Full Name:** Suzhou Suncadia Biopharmaceuticals Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2027-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Suzhou Suncadia Biopharmaceuticals Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** A trial to evaluate the tolerability and efficacy of SHR-A1921 in combination with adbelizumab and SHR-8068 with or without carboplatin in patients with advanced non-small cell lung cancer

### Conditions Module

**Conditions:**

- Advanced Non-small Cell Lung Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 124

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: SHR-A1921；Adebrelimab；SHR-8068；carboplatin

**Label:** SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin

**Description:** SHR-A1921:Specified dose on specified days. SHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified days. Carboplatin:Specified dose on specified days.

**Name:** SHR-A1921；Adebrelimab；SHR-8068；carboplatin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** DLT

**Time Frame:** 21 days after the first dose

**Measure:** ORR based on RECIST v1.1 assessment.

**Time Frame:** All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years

#### Secondary Outcomes

**Measure:** Adverse event

**Time Frame:** All informed subjects signed informed consent from the beginning to the end of the safety follow-up period， up to 2 years

**Measure:** DCR based on RECIST v1.1 assessment

**Time Frame:** All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
2. Aged 18-75 at the time of signing the informed consent;
3. Histologically or cytologically confirmed patients with locally advanced or metastatic non-cellular lung cancer who are not eligible for surgical resection or radical concurrent chemoradiotherapy;
4. At least one measurable lesion consistent with RECIST v1.1;
5. ECOG PS score: 0-1;
6. The organ function level is good;

Exclusion Criteria:

1. Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
2. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
3. Previous or co-existing malignant neoplasms;
4. The presence of any active or known autoimmune disease;
5. Have clinical symptoms or diseases of the heart that are not well controlled;
6. People with past or current interstitial pneumonia/interstitial lung disease;
7. Known allergic reactions to any component of SHR-A1921, Adebrelimab, or severe allergic reactions to other monoclonal antibodies;
8. Have previously received topoisomerase I inhibitors (including but not limited to irinotecan, Topotecan), TROP-2ADC, or ADC drugs containing topoisomerase I inhibitors; Previously received anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody treatment;

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mengbo.zhao@hengrui.com

**Name:** Mengbo Zhao

**Phone:** 0518-82342973

**Role:** CONTACT

**Contact 2:**

**Email:** ze.zhang.zz1@hengrui.com

**Name:** Ze Zhang

**Phone:** 0518-82342973

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

- ID: D000008175

- Term: Lung Neoplasms

- 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

### 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: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- 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

- 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

### Condition Browse Module - Meshes

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M18650

- Name: Carboplatin

- Relevance: HIGH

- As Found: System

### Intervention Browse Module - Meshes

- ID: D000016190

- Term: Carboplatin

### Misc Info Module

- Version Holder: 2024-05-31
