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A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients

NCT07171606•Shenyang Sunshine Pharmaceutical Co., LTD.

View on ClinicalTrials.gov

Summary

This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC

Detailed Description

This study is a study of SSGJ-706 monotherapy and combination therapy for advanced NSCLC Patients. This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced NSCLC Patients.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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-706
•The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Locations (1)

Institute of The Shanghai Pulmonary Hospital

Shanghai, China

Key Dates

Start Date

October 24, 2025

Primary Completion Date

August 31, 2026

Completion Date

August 31, 2027

Last Updated

December 18, 2025

Enrollment

240

ESTIMATED participants

Conditions

First-line Advanced NSCLC Patients

Interventions

SSGJ-706

DRUG

pemetrexed /carboplatin

DRUG

Carboplatin/Paclitaxel

DRUG

PD-1 Inhibitor + Chemotherapy

DRUG

Contacts

Shengxiang Ren

CONTACT

13816756732 harry_ren@126.com