Recruiting

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

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What is being tested

SSGJ-707

Drug
Who is being recruted

From 18 to 75 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2024
See protocol details

Summary

Principal SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study ContactLin Wu, MD, Ph.D
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 15, 2024

Actual date on which the first participant was enrolled.

This clinical trial is designed to test a new treatment, SSGJ-707, for patients diagnosed with advanced non-small cell lung cancer (NSCLC) that has a positive PD-L1 status, meaning the cancer cells have a specific protein that could respond to this treatment. The study is split into two groups: one for patients with non-squamous NSCLC and the other for those with squamous NSCLC. The main goal is to find out if SSGJ-707 can effectively treat these types of lung cancer and to assess its safety. This research is important as it may provide a new option for patients who currently have limited treatment choices. Participants in the study will receive SSGJ-707 as a standalone treatment, meaning no other cancer drugs will be given simultaneously. The drug is administered at different dose levels to see which is most effective and safe for patients. Researchers will carefully monitor how well the cancer responds to the treatment and track any side effects experienced by the participants to ensure their safety. By measuring these outcomes, the study aims to determine the best dose of SSGJ-707 that offers the most benefit with the least risk, potentially paving the way for new therapies in lung cancer care.

Official TitleA Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients
NCT06361927
Principal SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study ContactLin Wu, MD, Ph.D
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Males and/or females over age 18
Histologically and/or cytologically documented local advanced or metastatic NSCLC .
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Expected survival >=3 months.
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5 exclusion criteria prevent from participating
Known uncontrolled or symptomatic central nervous system metastatic disease.
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).
Inadequate organ or bone marrow function.
Pregnant or breast-feeding woman.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Group 5

Experimental
cohort B

Group 6

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

The Hunan Cancer Hospital

Changsha, ChinaOpen The Hunan Cancer Hospital in Google Maps
Recruiting
One Study Center
A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients | PatLynk