NCT06980272RecruitingPhase 3
SSGJ-707 in Advanced Non-Small Cell Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 24 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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%.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 420 (estimated)
- First submitted
- 12 May 2025
- Start date
- 20 Jun 2025
- Primary completion date
- 30 Jul 2026
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Diseases
- Lung cancer
- NCT number
- NCT06980272
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 420
- From 20 Jun 2025 to the primary completion date, 30 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unresolved toxicity from prior anti-tumor treatment, defined as toxicity not returning to NCI CTCAE Version 5.0 Grade 0 or 1.
- Known history of severe allergy to any component of the investigational drug, or history of severe allergic reactions to chimeric or humanized antibodies.
Other illness
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- History of immunodeficiency; positive for HIV antibodies;
- Known active tuberculosis (TB);
Lab values
- Presence of EGFR-sensitive mutations or ALK fusion-positive NSCLC.
Other
- Presence of small cell carcinoma components in histological pathology.
- 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.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.