SSGJ-707 in Advanced Non-Small Cell Lung Cancer
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-707, Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Advanced Non-Small Cell Lung Cancer. Basic parameters: from 18 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 →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug SSGJ-707
Subjects receive SSGJ-707 intravenously. - Drug Pembrolizumab
Subjects receive Pembrolizumab intravenously.
Primary outcome measures
- PFS assessed by IRRC per RECIST v1.1 [Time frame: Up to 2 approximately years]
Secondary outcome measures (12)
- OS [Time frame: Up to 2 approximately years]
- ORR assessed by IRRC per RECIST v1.1 [Time frame: Up to 2 approximately years]
- DoR assessed by IRRC per RECIST v1.1 [Time frame: Up to 2 approximately years]
- DCR assessed by IRRC per RECIST v1.1 [Time frame: Up to 2 approximately years]
- TTR assessed by IRRC per RECIST v1.1 [Time frame: Up to 2 approximately years]
- PFS assessed by investigator per RECIST v1.1 [Time frame: Up to 2 approximately years]
- ORR assessed by the investigator per RECIST v1.1 [Time frame: Up to 2 approximately years]
- DoR assessed by the investigator per RECIST v1.1 [Time frame: Up to 2 approximately years]
- DCR assessed by the investigator per RECIST v1.1 [Time frame: Up to 2 approximately years]
- TTR assessed by the investigator per RECIST v1.1 [Time frame: Up to 2 approximately years]
- AE [Time frame: Up to 2 approximately years]
- ADA [Time frame: Up to 2 approximately years]
Eligibility criteria
Inclusion criteria
- Willing to participate in the study voluntarily, agree to comply with and complete all study procedures, and sign the Informed Consent Form (ICF).
- At least 18 years of age at the time of signing the ICF, regardless of gender.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- Life expectancy of at least 12 weeks.
- Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
- No prior systemic anti-tumor treatment for locally advanced or metastatic NSCLC.
- At least one measurable tumor lesion as a target lesion according to RECIST v1.1 criteria.
Exclusion criteria
- Presence of small cell carcinoma components in histological pathology.
- Presence of EGFR-sensitive mutations or ALK fusion-positive NSCLC.
- Known BRAF V600E mutation, MET exon 14 skipping mutation, NTRK fusion, RET fusion, or ROS1 fusion-positive NSCLC.
- Presence of brainstem, leptomeningeal, spinal cord metastasis or compression.
- Unresolved toxicity from prior anti-tumor treatment, defined as toxicity not returning to NCI CTCAE Version 5.0 Grade 0 or 1.
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- History of immunodeficiency; positive for HIV antibodies;
- Known active tuberculosis (TB);
- Known history of severe allergy to any component of the investigational drug, or history of severe allergic reactions to chimeric or humanized antibodies.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Shanghai East Hospital — Shanghai
Identifiers
NCT: NCT06980272 · SSGJ-707-NSCLC-III-01