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Trial Title:
A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients
NCT ID:
NCT06412471
Condition:
First-line Advanced NSCLC Patients
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SSGJ-707
Description:
bispecific antibody
Arm group label:
Arm 1
Arm group label:
Arm 2
Arm group label:
Arm 3
Arm group label:
Arm 5
Arm group label:
Arm 6
Arm group label:
Arm 7
Arm group label:
Arm 8
Arm group label:
Arm 9
Intervention type:
Drug
Intervention name:
carboplatin
Description:
chemotherapy
Arm group label:
Arm 1
Arm group label:
Arm 10
Arm group label:
Arm 2
Arm group label:
Arm 3
Arm group label:
Arm 4
Arm group label:
Arm 5
Arm group label:
Arm 6
Arm group label:
Arm 7
Arm group label:
Arm 8
Arm group label:
Arm 9
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
chemotherapy
Arm group label:
Arm 1
Arm group label:
Arm 2
Arm group label:
Arm 3
Arm group label:
Arm 4
Intervention type:
Drug
Intervention name:
paclitaxel
Description:
chemotherapy
Arm group label:
Arm 10
Arm group label:
Arm 5
Arm group label:
Arm 6
Arm group label:
Arm 7
Arm group label:
Arm 8
Intervention type:
Drug
Intervention name:
PD-1/L1
Description:
Immune checkpoint inhibitors
Arm group label:
Arm 10
Arm group label:
Arm 4
Intervention type:
Drug
Intervention name:
Paclitaxel-albumin
Description:
chemotherapy
Arm group label:
Arm 9
Summary:
This study includes two parts, part A is for non-squamous NSCLC and part B is for
squamous NSCLC.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of The Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Jia Li
Phone:
13975895664
Email:
13975895664@163.com
Start date:
July 26, 2024
Completion date:
August 2025
Lead sponsor:
Agency:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Agency class:
Industry
Source:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06412471
