A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients
NCT ID: NCT07171606
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2025-10-24
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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dose level 1 of SSGJ-706 monotherapy
SSGJ-706
PD-1/PD-L1 bispecific antibody
dose level 2 of SSGJ-706 monotherapy
SSGJ-706
PD-1/PD-L1 bispecific antibody
dose level 1 of SSGJ-706 combined with chemotherapy
SSGJ-706
PD-1/PD-L1 bispecific antibody
pemetrexed /carboplatin
chemotherapy
dose level 2 of SSGJ-706 combined with chemotherapy
SSGJ-706
PD-1/PD-L1 bispecific antibody
Carboplatin/Paclitaxel
chemotherapy
PD-1/L1 combined with chemotherapy
PD-1 Inhibitor + Chemotherapy
control group
Interventions
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SSGJ-706
PD-1/PD-L1 bispecific antibody
pemetrexed /carboplatin
chemotherapy
Carboplatin/Paclitaxel
chemotherapy
PD-1 Inhibitor + Chemotherapy
control group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shenyang Sunshine Pharmaceutical Co., LTD.
INDUSTRY
Responsible Party
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Locations
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Institute of The Shanghai Pulmonary Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Shengxiang Ren
Role: primary
Other Identifiers
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SSGJ-706-201
Identifier Type: -
Identifier Source: org_study_id