Testing SSGJ-707 for advanced lung cancer patients with PD-L1 positivity

A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients

This study is testing a new treatment called SSGJ-707 to see if it can help people with advanced lung cancer who have a specific marker called PD-L1.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06361927 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of SSGJ-707 monotherapy in patients with first-line PD-L1 positive advanced non-small cell lung cancer (NSCLC). It includes two cohorts: one for non-squamous NSCLC and another for squamous NSCLC. Participants will receive various doses of SSGJ-707 to determine the optimal treatment approach. The study aims to provide insights into the potential benefits of this therapy for advanced NSCLC patients.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with advanced or metastatic NSCLC and an ECOG performance status of 0-1.

Not a fit: Patients with uncontrolled central nervous system metastases or significant adverse events from prior therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with advanced NSCLC who are PD-L1 positive.

How similar studies have performed: While this approach is being explored, similar studies have shown promise in targeting PD-L1 positive NSCLC, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented local advanced or metastatic NSCLC .
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>=3 months.
5. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to SSGJ-707. 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

Changsha, Hunan

• The Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)

Study contacts

• Principal investigator: Lin Wu, MD, Ph.D — The Hunan Cancer Hospital
• Study coordinator: Lin Wu, MD, Ph.D

Conditions NSCLC