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

Sunshine Guojian Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: First-line Advanced NSCLC Patients

Treatments: Drug: carboplatin; Drug: SSGJ-707; Drug: paclitaxel; Drug: Paclitaxel-albumin; Drug: PD-1/L1; Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT06412471

SSGJ-707-NSCLC-II-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 235 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-707 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: Single Group Assignment

Masking: None (Open label)

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235 participants in 10 patient groups

Arm 1

Experimental group

Description:

dose level 1 of SSGJ-707 combined with chemotherapy

Treatment:

Drug: Pemetrexed

Drug: SSGJ-707

Drug: carboplatin

Arm 2

Experimental group

Description:

dose level 2 of SSGJ-707 combined with chemotherapy

Treatment:

Drug: Pemetrexed

Drug: SSGJ-707

Drug: carboplatin

Arm 3

Experimental group

Description:

dose level 3 of SSGJ-707 combined with chemotherapy

Treatment:

Drug: Pemetrexed

Drug: SSGJ-707

Drug: carboplatin

Arm 4

Experimental group

Description:

PD-1/L1 combined with chemotherapy

Treatment:

Drug: Pemetrexed

Drug: PD-1/L1

Drug: carboplatin

Arm 5

Experimental group

Description:

dose level 1 of SSGJ-707 combined with chemotherapy

Treatment:

Drug: paclitaxel

Drug: SSGJ-707

Drug: carboplatin

Arm 6

Experimental group

Description:

dose level 2 of SSGJ-707 combined with chemotherapy

Treatment:

Drug: paclitaxel

Drug: SSGJ-707

Drug: carboplatin

Arm 7

Experimental group

Description:

dose level 3 of SSGJ-707 combined with chemotherapy

Treatment:

Drug: paclitaxel

Drug: SSGJ-707

Drug: carboplatin

Arm 8

Experimental group

Description:

Selected dose of SSGJ-707 combined with chemotherapy

Treatment:

Drug: paclitaxel

Drug: SSGJ-707

Drug: carboplatin

Arm 9

Experimental group

Description:

Selected dose of SSGJ-707 combined with chemotherapy

Treatment:

Drug: Paclitaxel-albumin

Drug: SSGJ-707

Drug: carboplatin

Arm 10

Experimental group

Description:

PD-1/L1 combined with chemotherapy

Treatment:

Drug: PD-1/L1

Drug: paclitaxel

Drug: carboplatin