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

NCT06412471 | Recruiting Phase 2

• 1 other identifier: SSGJ-707-NSCLC-II-02
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

First-line Advanced NSCLC Patients

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective response rate

  12 months

• Safety and tolerability

  Safety and tolerability assessed by incidence and severity of adverse events

  12 months

Secondary Outcomes (1)

• PFS

  24 months

Study Arms (10)

Arm 1

EXPERIMENTAL

dose level 1 of SSGJ-707 combined with chemotherapy

Drug: SSGJ-707; Drug: carboplatin; Drug: Pemetrexed

Arm 2

EXPERIMENTAL

dose level 2 of SSGJ-707 combined with chemotherapy

Drug: SSGJ-707; Drug: carboplatin; Drug: Pemetrexed

Arm 3

EXPERIMENTAL

dose level 3 of SSGJ-707 combined with chemotherapy

Drug: SSGJ-707; Drug: carboplatin; Drug: Pemetrexed

Arm 4

EXPERIMENTAL

PD-1/L1 combined with chemotherapy

Drug: carboplatin; Drug: Pemetrexed; Drug: PD-1/L1

Arm 5

EXPERIMENTAL

dose level 1 of SSGJ-707 combined with chemotherapy

Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel

Arm 6

EXPERIMENTAL

dose level 2 of SSGJ-707 combined with chemotherapy

Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel

Arm 7

EXPERIMENTAL

dose level 3 of SSGJ-707 combined with chemotherapy

Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel

Arm 8

EXPERIMENTAL

Selected dose of SSGJ-707 combined with chemotherapy

Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel

Arm 9

EXPERIMENTAL

Selected dose of SSGJ-707 combined with chemotherapy

Drug: SSGJ-707; Drug: carboplatin; Drug: Paclitaxel-albumin

Arm 10

EXPERIMENTAL

PD-1/L1 combined with chemotherapy

Drug: carboplatin; Drug: paclitaxel; Drug: PD-1/L1

Interventions

SSGJ-707 DRUG

bispecific antibody

Arm 1; Arm 2; Arm 3; Arm 5; Arm 6; Arm 7; Arm 8; Arm 9

carboplatin DRUG

chemotherapy

Arm 1; Arm 10; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6; Arm 7; Arm 8; Arm 9

Pemetrexed DRUG

chemotherapy

Arm 1; Arm 2; Arm 3; Arm 4

paclitaxel DRUG

chemotherapy

Arm 10; Arm 5; Arm 6; Arm 7; Arm 8

PD-1/L1 DRUG

Immune checkpoint inhibitors

Arm 10; Arm 4

Paclitaxel-albumin DRUG

chemotherapy

Arm 9

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Signed informed consent form.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Institute of The Hunan Cancer Hospital

Changsha, China

RECRUITING

MeSH Terms

Interventions

Carboplatin; Pemetrexed; Paclitaxel; Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Lin Wu, MD, Ph.D

CONTACT

0731-89762302; wulin-calf@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 14, 2024
• Study Start: July 26, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)