SSGJ-707 versus pembrolizumab for advanced non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Shanghai East Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Caicun Zhou
• Email: caicunzhoudr@tongji.edu.cn
• Phone: 13301825532

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.