Advanced Non-Small Cell Lung Cancer
Conditions
Brief summary
This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of SSGJ-707 comparing Pembrolizumab in subjects with advanced NSCLC whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.
Interventions
DRUGSSGJ-707
Subjects receive SSGJ-707 intravenously.
DRUGPembrolizumab
Subjects receive Pembrolizumab intravenously.
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willing to participate in the study voluntarily, agree to comply with and complete all study procedures, and sign the Informed Consent Form (ICF). 2. At least 18 years of age at the time of signing the ICF, regardless of gender. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. 4. Life expectancy of at least 12 weeks. 5. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC). 6. No prior systemic anti-tumor treatment for locally advanced or metastatic NSCLC. 7. At least one measurable tumor lesion as a target lesion according to RECIST v1.1 criteria.
Exclusion criteria
1. Presence of small cell carcinoma components in histological pathology. 2. Presence of EGFR-sensitive mutations or ALK fusion-positive NSCLC. 3. Known BRAF V600E mutation, MET exon 14 skipping mutation, NTRK fusion, RET fusion, or ROS1 fusion-positive NSCLC. 4. Presence of brainstem, leptomeningeal, spinal cord metastasis or compression. 5. Unresolved toxicity from prior anti-tumor treatment, defined as toxicity not returning to NCI CTCAE Version 5.0 Grade 0 or 1. 6. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 7. History of immunodeficiency; positive for HIV antibodies; 8. Known active tuberculosis (TB); 9. Known history of severe allergy to any component of the investigational drug, or history of severe allergic reactions to chimeric or humanized antibodies. 10. Pregnant or breastfeeding women. 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 |
|---|---|---|
| PFS assessed by IRRC per RECIST v1.1 | Up to 2 approximately years | Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR assessed by IRRC per RECIST v1.1 | Up to 2 approximately years | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1. |
| DoR assessed by IRRC per RECIST v1.1 | Up to 2 approximately years | Duration of response (DoR) assessed according to RECIST v1.1. |
| DCR assessed by IRRC per RECIST v1.1 | Up to 2 approximately years | Disease control rate (DCR) assessed according to RECIST v1.1. |
| TTR assessed by IRRC per RECIST v1.1 | Up to 2 approximately years | Time to response (TTR) is defined as the time to response base on RECIST v1.1. |
| PFS assessed by investigator per RECIST v1.1 | Up to 2 approximately years | Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first). |
| ORR assessed by the investigator per RECIST v1.1 | Up to 2 approximately years | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1. |
| OS | Up to 2 approximately years | Overall Survival (OS) is defined as the time from the start of treatment with SSGJ-707 until death due to any cause. |
| DCR assessed by the investigator per RECIST v1.1 | Up to 2 approximately years | Disease control rate (DCR) assessed according to RECIST v1.1. |
| TTR assessed by the investigator per RECIST v1.1 | Up to 2 approximately years | Time to response (TTR) is defined as the time to response base on RECIST v1.1. |
| AE | Up to 2 approximately years | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
| ADA | Up to 2 approximately years | Number of subjects with detectable anti-drug antibodies (ADA). |
| PD-L1 expression | Up to 2 approximately years | The correlationship between PD-L1 expression and SSGJ-707 anti-tumor activity. |
| DoR assessed by the investigator per RECIST v1.1 | Up to 2 approximately years | Duration of response (DoR) assessed according to RECIST v1.1. |
Countries
China
Contacts
Primary ContactCaicun Zhou
Outcome results
None listed