Non Small Cell Lung Cancer
Conditions
Keywords
Non Small Cell Lung Cancer, PD-1/PD-L1, B7-H3, IL-15
Brief summary
This study is an open, multicenter, phase 2 clinical trial of SPGL008 in combination with SSGJ-706 ± chemotherapy for the treatment of advanced non-small cell lung cancer. The objective is to evaluate the safety and efficacy of SPGL008 combined with SSGJ-706 in participants with driver gene-negative advanced non-small cell lung cancer.
Interventions
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
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
No
Inclusion criteria
1. Males and/or females over age 18-75 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. Adequate organ or bone marrow function. 6. Signed informed consent form.
Exclusion criteria
1. Known positive driver genes 2. Pregnant or breast-feeding woman. 3. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria 4. Known allergies, hypersensitivity, or intolerance to SSGJ-706/SPGL008 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 | Description |
|---|---|---|
| Incidence of Adverse Events(AEs) assessed by NCI-CTCAE v6.0 | 24 months | Collect and analyze the incidence of adverse events to evaluate safety and tolerability per NCI-CTCAE v6.0 |
| Objective Response Rate(ORR) | 24 months | The efficacy of solid tumors was evaluated according to RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | 24 months | Collect blood samples at the preset time points, measure the concentrations, draw the concentration-time curve, and select the highest point on the curve. |
| Area under the curve (AUC) | 24months | Based on the concentrations at multiple time points and the time |
| Half-life (T1/2) | 24months | Calculate the half-life based on the concentration of the collected data. |
| Lymphocytes | 24months | Calculate and analyze the relationship between lymphocytes and efficacy |
| Immunogenicity | 24months | Subjects will be tested for anti-drug antibody (ADA), and ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb). |
| Cytokines | 24months | Calculate and analyze the relationship between cytokines and efficacy |
Contacts
CONTACTLIN WU
Outcome results
None listed