A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SSGJ-706, pemetrexed /carboplatin, Carboplatin/Paclitaxel, PD-1 Inhibitor + Chemotherapy.
- Who it may be relevant to
- Registry conditions: First-line Advanced NSCLC Patients. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug SSGJ-706
PD-1/PD-L1 bispecific antibody - Drug pemetrexed /carboplatin
chemotherapy - Drug Carboplatin/Paclitaxel
chemotherapy - Drug PD-1 Inhibitor + Chemotherapy
control group
Primary outcome measures
- Objective response rate (ORR) [Time frame: 12 months]
- Incidence and severity of Adverse Events [Time frame: 12 months]
Secondary outcome measures (5)
- DCR : Disease Control Rate [Time frame: 12 months]
- PFS：Progression-Free Survival [Time frame: 24 month]
- OS：Overall Survival [Time frame: 24 month]
- The blood concentration of SSGJ-706 [Time frame: Approximately 6 months]
- The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab) [Time frame: Approximately 6 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of The Shanghai Pulmonary Hospital — Shanghai
Identifiers
NCT: NCT07171606 · SSGJ-706-201