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

Phase 2

Recruiting

• Conditions: NSCLC
• Interventions: Drug: SSGJ-707

• Registration Number: NCT06361927
• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Brief Summary

This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC.

Detailed Description

This study is a study of SSGJ-707 monotherapy in First-line PD-L1 Positive advanced NSCLC Patients. This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC. Each cohort will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-12
• Last Update Submitted: 2024-05-14
• Study Start: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cohort A：dose level 1 of SSGJ-707	SSGJ-707	-
cohort B：dose level 2 of SSGJ-707	SSGJ-707	cohort B
cohort A：dose level 3 of SSGJ-707	SSGJ-707	-
cohort B：dose level 1 of SSGJ-707	SSGJ-707	-
cohort A：dose level 2 of SSGJ-707	SSGJ-707	-
cohort B：dose level 3 of SSGJ-707	SSGJ-707	-

Primary Outcome Measures

Name	Time	Method
ORR	12 months	Objective response rate

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	12 months	Safety and tolerability assessed by incidence and severity of adverse events

Trial Locations

Locations (1)

The Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China