A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients
Phase 2
Recruiting
- Conditions
- First-line Advanced NSCLC Patients
- Interventions
- Drug: Paclitaxel-albuminDrug: PD-1/L1
- Registration Number
- NCT06412471
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 235
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 2 Pemetrexed dose level 2 of SSGJ-707 combined with chemotherapy Arm 3 SSGJ-707 dose level 3 of SSGJ-707 combined with chemotherapy Arm 7 SSGJ-707 dose level 3 of SSGJ-707 combined with chemotherapy Arm 1 SSGJ-707 dose level 1 of SSGJ-707 combined with chemotherapy Arm 9 Paclitaxel-albumin Selected dose of SSGJ-707 combined with chemotherapy Arm 1 Pemetrexed dose level 1 of SSGJ-707 combined with chemotherapy Arm 2 SSGJ-707 dose level 2 of SSGJ-707 combined with chemotherapy Arm 4 PD-1/L1 PD-1/L1 combined with chemotherapy Arm 10 PD-1/L1 PD-1/L1 combined with chemotherapy Arm 2 carboplatin dose level 2 of SSGJ-707 combined with chemotherapy Arm 6 carboplatin dose level 2 of SSGJ-707 combined with chemotherapy Arm 8 carboplatin Selected dose of SSGJ-707 combined with chemotherapy Arm 9 SSGJ-707 Selected dose of SSGJ-707 combined with chemotherapy Arm 6 SSGJ-707 dose level 2 of SSGJ-707 combined with chemotherapy Arm 8 SSGJ-707 Selected dose of SSGJ-707 combined with chemotherapy Arm 5 SSGJ-707 dose level 1 of SSGJ-707 combined with chemotherapy Arm 4 Pemetrexed PD-1/L1 combined with chemotherapy Arm 7 paclitaxel dose level 3 of SSGJ-707 combined with chemotherapy Arm 1 carboplatin dose level 1 of SSGJ-707 combined with chemotherapy Arm 3 carboplatin dose level 3 of SSGJ-707 combined with chemotherapy Arm 3 Pemetrexed dose level 3 of SSGJ-707 combined with chemotherapy Arm 4 carboplatin PD-1/L1 combined with chemotherapy Arm 6 paclitaxel dose level 2 of SSGJ-707 combined with chemotherapy Arm 5 paclitaxel dose level 1 of SSGJ-707 combined with chemotherapy Arm 5 carboplatin dose level 1 of SSGJ-707 combined with chemotherapy Arm 10 carboplatin PD-1/L1 combined with chemotherapy Arm 7 carboplatin dose level 3 of SSGJ-707 combined with chemotherapy Arm 8 paclitaxel Selected dose of SSGJ-707 combined with chemotherapy Arm 9 carboplatin Selected dose of SSGJ-707 combined with chemotherapy Arm 10 paclitaxel PD-1/L1 combined with chemotherapy
- Primary Outcome Measures
Name Time Method ORR 12 months Objective response rate
Safety and tolerability 12 months Safety and tolerability assessed by incidence and severity of adverse events
- Secondary Outcome Measures
Name Time Method PFS 24 months The efficacy end points
Trial Locations
- Locations (1)
Institute of The Hunan Cancer Hospital
🇨🇳Changsha, China