A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients
1 other identifier
interventional
240
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2025
CompletedFirst Posted
Study publicly available on registry
September 12, 2025
CompletedStudy Start
First participant enrolled
October 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
December 18, 2025
August 1, 2025
10 months
September 1, 2025
December 10, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Objective response rate (ORR)
12 months
Incidence and severity of Adverse Events
12 months
Secondary Outcomes (5)
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
Study Arms (5)
dose level 1 of SSGJ-706 monotherapy
EXPERIMENTALdose level 2 of SSGJ-706 monotherapy
EXPERIMENTALdose level 1 of SSGJ-706 combined with chemotherapy
EXPERIMENTALdose level 2 of SSGJ-706 combined with chemotherapy
EXPERIMENTALPD-1/L1 combined with chemotherapy
ACTIVE COMPARATORInterventions
PD-1/PD-L1 bispecific antibody
Eligibility Criteria
You may qualify if:
- Males and/or females over age 18
- Histologically and/or cytologically documented local advanced or metastatic NSCLC .
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival \>=3 months.
- Signed informed consent form.
You may not qualify if:
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- 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).
- Inadequate organ or bone marrow function.
- Pregnant or breast-feeding woman.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of The Shanghai Pulmonary Hospital
Shanghai, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2025
First Posted
September 12, 2025
Study Start
October 24, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
December 18, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share