Clinical trial NCT06980272: SSGJ-707 in Advanced Non-Small Cell Lung Cancer
Official title: A Randomized Controlled, Multi-center Phase III Clinical Trial of SSGJ-707 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Advanced Non-Small Cell Lung Cancer
Lead sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.


Eligibility criteria: 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.

Primary outcomes:
measure: PFS assessed by IRRC per RECIST v1.1
timeFrame: Up to 2 approximately years
Secondary outcomes:
measure: OS
timeFrame: Up to 2 approximately years
measure: ORR assessed by IRRC per RECIST v1.1
timeFrame: Up to 2 approximately years
measure: DoR assessed by IRRC per RECIST v1.1
timeFrame: Up to 2 approximately years
measure: DCR assessed by IRRC per RECIST v1.1
timeFrame: Up to 2 approximately years
measure: TTR assessed by IRRC per RECIST v1.1
timeFrame: Up to 2 approximately years
measure: PFS assessed by investigator per RECIST v1.1
timeFrame: Up to 2 approximately years
measure: ORR assessed by the investigator per RECIST v1.1
timeFrame: Up to 2 approximately years
measure: DoR assessed by the investigator per RECIST v1.1
timeFrame: Up to 2 approximately years
measure: DCR assessed by the investigator per RECIST v1.1
timeFrame: Up to 2 approximately years
measure: TTR assessed by the investigator per RECIST v1.1
timeFrame: Up to 2 approximately years
measure: AE
timeFrame: Up to 2 approximately years
measure: ADA
timeFrame: Up to 2 approximately years
measure: PD-L1 expression
timeFrame: Up to 2 approximately years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The Shanghai East Hospital
Study officials:
References: