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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07171606

Enrollment

240

Registered

2025-09-12

Start date

2025-10-24

Completion date

2027-08-31

Last updated

2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First-line Advanced NSCLC Patients

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.

Interventions

DRUGSSGJ-706

PD-1/PD-L1 bispecific antibody

DRUGpemetrexed /carboplatin

chemotherapy

DRUGCarboplatin/Paclitaxel

chemotherapy

DRUGPD-1 Inhibitor + Chemotherapy

control group

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR)	12 months
Incidence and severity of Adverse Events	12 months

Secondary

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

Countries

China

Contacts

Primary ContactShengxiang Ren

harry_ren@126.com13816756732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026