## Protocol Section
### Identification Module
**NCT ID:** NCT06412471

**Brief Title:** A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients

**Official Title:** A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients

#### Organization Study ID Info
**ID:** SSGJ-707-NSCLC-II-02
#### Organization
**Class:** INDUSTRY
**Full Name:** Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

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

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC.

**Detailed Description:** This study is a study of SSGJ-707 combination therapy in First-line advanced NSCLC Patients. This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.

### Conditions Module

**Conditions:**

- First-line Advanced NSCLC Patients

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 235

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** dose level 1 of SSGJ-707 combined with chemotherapy

**Intervention Names:**

- Drug: SSGJ-707

- Drug: carboplatin

- Drug: Pemetrexed

**Label:** Arm 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** dose level 2 of SSGJ-707 combined with chemotherapy

**Intervention Names:**

- Drug: SSGJ-707

- Drug: carboplatin

- Drug: Pemetrexed

**Label:** Arm 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** dose level 3 of SSGJ-707 combined with chemotherapy

**Intervention Names:**

- Drug: SSGJ-707

- Drug: carboplatin

- Drug: Pemetrexed

**Label:** Arm 3

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** PD-1/L1 combined with chemotherapy

**Intervention Names:**

- Drug: carboplatin

- Drug: Pemetrexed

- Drug: PD-1/L1

**Label:** Arm 4

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** dose level 1 of SSGJ-707 combined with chemotherapy

**Intervention Names:**

- Drug: SSGJ-707

- Drug: carboplatin

- Drug: paclitaxel

**Label:** Arm 5

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** dose level 2 of SSGJ-707 combined with chemotherapy

**Intervention Names:**

- Drug: SSGJ-707

- Drug: carboplatin

- Drug: paclitaxel

**Label:** Arm 6

**Type:** EXPERIMENTAL

#### Arm Group 7

**Description:** dose level 3 of SSGJ-707 combined with chemotherapy

**Intervention Names:**

- Drug: SSGJ-707

- Drug: carboplatin

- Drug: paclitaxel

**Label:** Arm 7

**Type:** EXPERIMENTAL

#### Arm Group 8

**Description:** Selected dose of SSGJ-707 combined with chemotherapy

**Intervention Names:**

- Drug: SSGJ-707

- Drug: carboplatin

- Drug: paclitaxel

**Label:** Arm 8

**Type:** EXPERIMENTAL

#### Arm Group 9

**Description:** Selected dose of SSGJ-707 combined with chemotherapy

**Intervention Names:**

- Drug: SSGJ-707

- Drug: carboplatin

- Drug: Paclitaxel-albumin

**Label:** Arm 9

**Type:** EXPERIMENTAL

#### Arm Group 10

**Description:** PD-1/L1 combined with chemotherapy

**Intervention Names:**

- Drug: carboplatin

- Drug: paclitaxel

- Drug: PD-1/L1

**Label:** Arm 10

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm 1

- Arm 2

- Arm 3

- Arm 5

- Arm 6

- Arm 7

- Arm 8

- Arm 9

**Description:** bispecific antibody

**Name:** SSGJ-707

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Arm 1

- Arm 10

- Arm 2

- Arm 3

- Arm 4

- Arm 5

- Arm 6

- Arm 7

- Arm 8

- Arm 9

**Description:** chemotherapy

**Name:** carboplatin

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Arm 1

- Arm 2

- Arm 3

- Arm 4

**Description:** chemotherapy

**Name:** Pemetrexed

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Arm 10

- Arm 5

- Arm 6

- Arm 7

- Arm 8

**Description:** chemotherapy

**Name:** paclitaxel

**Type:** DRUG

#### Intervention 5

**Arm Group Labels:**

- Arm 10

- Arm 4

**Description:** Immune checkpoint inhibitors

**Name:** PD-1/L1

**Type:** DRUG

#### Intervention 6

**Arm Group Labels:**

- Arm 9

**Description:** chemotherapy

**Name:** Paclitaxel-albumin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Objective response rate

**Measure:** ORR

**Time Frame:** 12 months

**Description:** Safety and tolerability assessed by incidence and severity of adverse events

**Measure:** Safety and tolerability

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** The efficacy end points

**Measure:** PFS

**Time Frame:** 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented local advanced or metastatic NSCLC .
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>=3 months.
5. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wulin-calf@vip.163.com

**Name:** Lin Wu, MD, Ph.D

**Phone:** 0731-89762302

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Changsha

**Contacts:**

***Contact 1:***

- **Email:** 13975895664@163.com

- **Name:** Jia Li

- **Phone:** 13975895664

- **Role:** CONTACT

**Country:** China

**Facility:** Institute of The Hunan Cancer Hospital

### IPD Sharing Statement Module

**IPD Sharing:** NO

## 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: NSCLC

- 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: M11172

- Name: Lung 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: 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: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M19537

- Name: Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M18650

- Name: Carboplatin

- Relevance: HIGH

- As Found: System

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M264

- Name: Pemetrexed

- Relevance: HIGH

- As Found: Strategies

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M20194

- Name: Antibodies, Bispecific

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- 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: D000068196

- Term: Albumin-Bound Paclitaxel

- ID: D000016190

- Term: Carboplatin

- ID: D000068437

- Term: Pemetrexed

### Misc Info Module

- Version Holder: 2024-05-31
