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

Shenyang Sunshine Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: First-line Advanced NSCLC Patients

Treatments: Drug: Carboplatin/Paclitaxel; Drug: SSGJ-706; Drug: pemetrexed /carboplatin; Drug: PD-1 Inhibitor + Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT07171606

SSGJ-706-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

240 participants in 5 patient groups

dose level 1 of SSGJ-706 monotherapy

Experimental group

Treatment:

Drug: SSGJ-706

dose level 2 of SSGJ-706 monotherapy

Experimental group

Treatment:

Drug: SSGJ-706

dose level 1 of SSGJ-706 combined with chemotherapy

Experimental group

Treatment:

Drug: pemetrexed /carboplatin

Drug: SSGJ-706

dose level 2 of SSGJ-706 combined with chemotherapy

Experimental group

Treatment:

Drug: SSGJ-706

Drug: Carboplatin/Paclitaxel

PD-1/L1 combined with chemotherapy

Active Comparator group

Treatment:

Drug: PD-1 Inhibitor + Chemotherapy