## Protocol Section
### Identification Module
**NCT ID:** NCT06416410

**Brief Title:** JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation

**Official Title:** An Open-label, Randomized, Positive Control, Multicenter Phase III Clinical Study. Evaluating JAB-21822 Combined With JAB-3312 Compared Tislelizumab Combined With Pemetrexed + Carboplatin in the First Line for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With KRAS p.G12C Mutation

#### Organization Study ID Info
**ID:** JAB-21822-3002
#### Organization
**Class:** INDUSTRY
**Full Name:** Jacobio Pharmaceuticals Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2027-02-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-17

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Jacobio Pharmaceuticals Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This Phase 3 study will evaluate the efficacy of JAB-21822+JAB-3312 versus tislelizumab (PD-1 Ab) combined with pemetrexed+carboplatin as the first line treatment in subjects with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

### Conditions Module

**Conditions:**

- Advanced Non-squamous Non-small-cell Lung Cancer

- Metastatic Non-squamous Non Small Cell Lung Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 392

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle

**Intervention Names:**

- Drug: JAB-21822

- Drug: JAB-3312

**Label:** JAB-21822+JAB-3312

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Tislelizumab injection, 21 days as a treatment cycle; Pemetrexed injection, 21 days as a treatment cycle; Carboplatin injection, 21 days as a treatment cycle

**Intervention Names:**

- Drug: Tislelizumab

- Drug: Pemetrexed

- Drug: Carboplatin

**Label:** Tislelizumab combined with Pemetrexed + Carboplatin

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- JAB-21822+JAB-3312

**Description:** JAB-21822 administered orally as a tablet

**Name:** JAB-21822

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Tislelizumab combined with Pemetrexed + Carboplatin

**Description:** Tislelizumab administered as an intravenous (IV) infusion

**Name:** Tislelizumab

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- JAB-21822+JAB-3312

**Description:** JAB-3312 administered orally as a tablet or capsule

**Name:** JAB-3312

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Tislelizumab combined with Pemetrexed + Carboplatin

**Description:** Pemetrexed administered as an intravenous (IV) infusion

**Name:** Pemetrexed

**Type:** DRUG

#### Intervention 5

**Arm Group Labels:**

- Tislelizumab combined with Pemetrexed + Carboplatin

**Description:** Carboplatin administered as an intravenous (IV) infusion

**Name:** Carboplatin

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** To be assessed by EORTC OLO-LC13

**Measure:** Patient Self-Evaluation Results (PRO)

**Time Frame:** From Baseline up to 4 years

**Description:** To be assessed by EORTC OLO-C30

**Measure:** Patient Self-Evaluation Results (PRO)

**Time Frame:** From Baseline up to 4 years

**Description:** To be assessed by EuroQoL(EQ)5D

**Measure:** Patient Self-Evaluation Results (PRO)

**Time Frame:** From Baseline up to 4 years

#### Primary Outcomes

**Description:** PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST)v1.1, per Independent Review Committee (IRC).

**Measure:** Outcome Progression-free Survival (PFS)

**Time Frame:** From Baseline up to 4 years

#### Secondary Outcomes

**Description:** Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1

**Measure:** Objective Response Rate (ORR)

**Time Frame:** From Baseline up to 4 years

**Description:** OS is defined as the time from randomization until death due to any cause

**Measure:** Overall Survival (OS)

**Time Frame:** From Baseline up to 4 years

**Measure:** Number of Participants With Treatment-Emergent Adverse Events

**Time Frame:** From Baseline up to 4 years

**Measure:** Number of Participants With Clinically Significant Changes in Vital Signs

**Time Frame:** From Baseline up to 4 years

**Measure:** Time to Maximum Plasma Concentration (Tmax)

**Time Frame:** Pre-dose Day 1 up to Day 64

**Measure:** Half life (t1/2)

**Time Frame:** Pre-dose Day 1 up to Day 64

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* A signed written informed consent is required before performing any study-related operations
* Age greater than or equal to 18 years old
* Histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirmed by the central lab
* No history of systemic anticancer therapy to the local advanced/metastatic disease
* Expected survival period greater than or equal to 3 months
* Having at least one target lesion according to RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) ≤ 1

Exclusion Criteria:

* Previous (≤2 years) or current solid tumors or hematologic tumors of other pathological types
* Carry other driver gene mutations with available target therapy, or carry other KRAS mutations
* Subjects with untreated central nervous system (CNS) metastases were excluded;
* Uncontrolled pleural effusion, pericardial effusion, and ascites
* Subjects with impaired heart function or clinically significant heart disease

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinicaltrials@jacobiopharma.com

**Name:** Jacobio Pharmaceuticals

**Phone:** 86-10-56315466

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Jacobio Pharmaceuticals

**Name:** Jacobio Pharmaceuticals

**Role:** STUDY_DIRECTOR

## 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: D000000970

- Term: Antineoplastic Agents

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000005493

- Term: Folic Acid Antagonists

- ID: D000019384

- Term: Nucleic Acid Synthesis Inhibitors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

### 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: M18650

- Name: Carboplatin

- Relevance: HIGH

- As Found: System

- ID: M264

- Name: Pemetrexed

- Relevance: HIGH

- As Found: Strategies

- ID: M137899

- Name: Tislelizumab

- Relevance: HIGH

- As Found: Meet

- 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: M1346

- Name: Antineoplastic Agents, Immunological

- 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: D000016190

- Term: Carboplatin

- ID: D000068437

- Term: Pemetrexed

- ID: C000707970

- Term: Tislelizumab

### Misc Info Module

- Version Holder: 2024-05-31
