SSGJ-707 in Advanced Non-Small Cell Lung Cancer

Shenyang Sunshine Pharmaceutical

Status and phase: Begins enrollment this month; Phase 3

Conditions: Advanced Non-Small Cell Lung Cancer

Treatments: Drug: Pembrolizumab; Drug: SSGJ-707

Study type: Interventional

Funder types: Industry

Identifiers

NCT06980272

SSGJ-707-NSCLC-III-01

Details and patient eligibility

About

This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of SSGJ-707 comparing Pembrolizumab in subjects with advanced NSCLC whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.

Enrollment: 420 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Willing to participate in the study voluntarily, agree to comply with and complete all study procedures, and sign the Informed Consent Form (ICF).
2. At least 18 years of age at the time of signing the ICF, regardless of gender.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
4. Life expectancy of at least 12 weeks.
5. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
6. No prior systemic anti-tumor treatment for locally advanced or metastatic NSCLC.
7. At least one measurable tumor lesion as a target lesion according to RECIST v1.1 criteria.

Exclusion criteria

1. Presence of small cell carcinoma components in histological pathology.
2. Presence of EGFR-sensitive mutations or ALK fusion-positive NSCLC.
3. Known BRAF V600E mutation, MET exon 14 skipping mutation, NTRK fusion, RET fusion, or ROS1 fusion-positive NSCLC.
4. Presence of brainstem, leptomeningeal, spinal cord metastasis or compression.
5. Unresolved toxicity from prior anti-tumor treatment, defined as toxicity not returning to NCI CTCAE Version 5.0 Grade 0 or 1.
6. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
7. History of immunodeficiency; positive for HIV antibodies;
8. Known active tuberculosis (TB);
9. Known history of severe allergy to any component of the investigational drug, or history of severe allergic reactions to chimeric or humanized antibodies.
10. Pregnant or breastfeeding women.

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: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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420 participants in 2 patient groups

SSGJ-707

Experimental group

Description:

Subjects receive SSGJ-707 monotherapy intravenously (IV), selected dose.

Treatment:

Drug: SSGJ-707

Pembrolizumab

Active Comparator group

Description:

Subjects receive Pembrolizumab monotherapy intravenously (IV), 200mg q3w.

Treatment:

Drug: Pembrolizumab