A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients

Not Applicable

Not yet recruiting

• Conditions: First-line Advanced NSCLC Patients
• Interventions: Drug: SSGJ-706; Drug: PD-1 Inhibitor + Chemotherapy; Drug: pemetrexed /carboplatin; Drug: Carboplatin/Paclitaxel

• Registration Number: NCT07171606
• Lead Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

Brief Summary

This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC

Detailed Description

This study is a study of SSGJ-706 monotherapy and combination therapy for advanced NSCLC Patients. This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced NSCLC Patients.

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-01
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Primary Completion: 2026-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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-706

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dose level 1 of SSGJ-706 monotherapy	SSGJ-706	-
dose level 2 of SSGJ-706 monotherapy	SSGJ-706	-
dose level 1 of SSGJ-706 combined with chemotherapy	SSGJ-706	-
dose level 1 of SSGJ-706 combined with chemotherapy	pemetrexed /carboplatin	-
dose level 2 of SSGJ-706 combined with chemotherapy	SSGJ-706	-
dose level 2 of SSGJ-706 combined with chemotherapy	Carboplatin/Paclitaxel	-
PD-1/L1 combined with chemotherapy	PD-1 Inhibitor + Chemotherapy	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	12 months
Incidence and severity of Adverse Events	12 months

Secondary Outcome Measures

Name	Time	Method
DCR : Disease Control Rate	12 months
PFS：Progression-Free Survival	24 month
OS：Overall Survival	24 month
The blood concentration of SSGJ-706	Approximately 6 months
The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab)	Approximately 6 months

Trial Locations

Locations (1)

Institute of The Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China