SSGJ-707 versus pembrolizumab for 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

This Phase III test will see if SSGJ-707 works as well as or better than pembrolizumab for adults with stage IIIB/IIIC (not suitable for radical therapy) or stage IV non-small cell lung cancer whose tumors have PD-L1 TPS ≥1% and who have ECOG performance status 0–1 and no prior systemic therapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. (Industry-sponsored)
• Drugs / interventions: Pembrolizumab
• Locations: 1 site (Shanghai)
• Trial ID: NCT06980272 on ClinicalTrials.gov

What this trial studies

This Phase III comparison enrolls adults with locally advanced (IIIB/IIIC) or metastatic (IV) NSCLC with PD-L1 Tumor Proportion Score ≥1% and ECOG 0–1. Eligible participants must have at least one measurable lesion per RECIST v1.1 and no prior systemic therapy for advanced disease. Participants receive either the experimental agent SSGJ-707 or pembrolizumab and are followed for efficacy and safety outcomes, including tumor response and survival measures, with adverse events recorded according to standard criteria. The trial aims to determine whether SSGJ-707 can provide similar or improved clinical benefit and tolerability compared with pembrolizumab.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically or cytologically confirmed stage IIIB/IIIC or IV NSCLC, PD-L1 TPS ≥1%, ECOG performance status 0–1, at least one measurable lesion, life expectancy ≥12 weeks, and no prior systemic therapy for advanced disease are ideal candidates.

Not a fit: Patients whose tumors have targetable driver mutations (for example EGFR, ALK, BRAF V600E, MET exon 14, NTRK, RET, ROS1), tumors with small cell components, or other exclusionary conditions such as certain central nervous system involvement are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, SSGJ-707 could offer an alternative to pembrolizumab with the potential for improved tumor control or a different safety profile in PD-L1–positive advanced NSCLC.

How similar studies have performed: Immune checkpoint inhibitors like pembrolizumab have shown clear benefit in PD-L1–positive advanced NSCLC, so this trial compares a novel agent against an established standard while SSGJ-707 remains experimental without published Phase III results.

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.

Where this trial is running

Shanghai

• The Shanghai East Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Caicun Zhou

Conditions Advanced Non-Small Cell Lung Cancer