A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients

This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC.

Study Overview

• Status: Recruiting
• Conditions: First-line Advanced NSCLC Patients
• Intervention / Treatment: Drug: Pemetrexed; Drug: paclitaxel; Drug: SSGJ-707; Drug: carboplatin; Drug: PD-1/L1; Drug: Paclitaxel-albumin

Detailed Description

This study is a study of SSGJ-707 combination therapy in First-line advanced NSCLC Patients. This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.

• Study Type: Interventional
• Enrollment (Estimated): 235
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lin Wu, MD, Ph.D; Phone Number: 0731-89762302; Email: wulin-calf@vip.163.com

Study Locations

• China
  • Changsha, China
    • Recruiting
    • Institute of The Hunan Cancer Hospital
    • Contact: Jia Li; Phone Number: 13975895664; Email: 13975895664@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; dose level 1 of SSGJ-707 combined with chemotherapy	Drug: Pemetrexed; chemotherapy; Drug: SSGJ-707; bispecific antibody; Drug: carboplatin; chemotherapy
Experimental: Arm 2; dose level 2 of SSGJ-707 combined with chemotherapy	Drug: Pemetrexed; chemotherapy; Drug: SSGJ-707; bispecific antibody; Drug: carboplatin; chemotherapy
Experimental: Arm 3; dose level 3 of SSGJ-707 combined with chemotherapy	Drug: Pemetrexed; chemotherapy; Drug: SSGJ-707; bispecific antibody; Drug: carboplatin; chemotherapy
Experimental: Arm 4; PD-1/L1 combined with chemotherapy	Drug: Pemetrexed; chemotherapy; Drug: carboplatin; chemotherapy; Drug: PD-1/L1; Immune checkpoint inhibitors
Experimental: Arm 5; dose level 1 of SSGJ-707 combined with chemotherapy	Drug: paclitaxel; chemotherapy; Drug: SSGJ-707; bispecific antibody; Drug: carboplatin; chemotherapy
Experimental: Arm 6; dose level 2 of SSGJ-707 combined with chemotherapy	Drug: paclitaxel; chemotherapy; Drug: SSGJ-707; bispecific antibody; Drug: carboplatin; chemotherapy
Experimental: Arm 7; dose level 3 of SSGJ-707 combined with chemotherapy	Drug: paclitaxel; chemotherapy; Drug: SSGJ-707; bispecific antibody; Drug: carboplatin; chemotherapy
Experimental: Arm 8; Selected dose of SSGJ-707 combined with chemotherapy	Drug: paclitaxel; chemotherapy; Drug: SSGJ-707; bispecific antibody; Drug: carboplatin; chemotherapy
Experimental: Arm 9; Selected dose of SSGJ-707 combined with chemotherapy	Drug: SSGJ-707; bispecific antibody; Drug: carboplatin; chemotherapy; Drug: Paclitaxel-albumin; chemotherapy
Experimental: Arm 10; PD-1/L1 combined with chemotherapy	Drug: paclitaxel; chemotherapy; Drug: carboplatin; chemotherapy; Drug: PD-1/L1; Immune checkpoint inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate	12 months
Safety and tolerability	Safety and tolerability assessed by incidence and severity of adverse events	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	The efficacy end points	24 months

Collaborators and Investigators

• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 12, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Folic Acid Antagonists; Carboplatin; Paclitaxel; Albumin-Bound Paclitaxel; Pemetrexed
• Other Study ID Numbers: SSGJ-707-NSCLC-II-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No