SSGJ-707 in Advanced Non-Small Cell Lung Cancer

NCT06980272 | Recruiting Phase 3 DMC

• 1 other identifier: SSGJ-707-NSCLC-III-01
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• PFS assessed by IRRC per RECIST v1.1

  Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).

  Up to 2 approximately years

Secondary Outcomes (13)

• OS

  Up to 2 approximately years

• ORR assessed by IRRC per RECIST v1.1

  Up to 2 approximately years

• DoR assessed by IRRC per RECIST v1.1

  Up to 2 approximately years

• DCR assessed by IRRC per RECIST v1.1

  Up to 2 approximately years

• TTR assessed by IRRC per RECIST v1.1

  Up to 2 approximately years

Study Arms (2)

SSGJ-707

EXPERIMENTAL

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

Drug: SSGJ-707

Pembrolizumab

ACTIVE COMPARATOR

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

Drug: Pembrolizumab

Interventions

SSGJ-707 DRUG

Subjects receive SSGJ-707 intravenously.

SSGJ-707

Pembrolizumab DRUG

Subjects receive Pembrolizumab intravenously.

Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

The Shanghai East Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Central Study Contacts

Caicun Zhou

CONTACT

13301825532; caicunzhoudr@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-05

Locations

CN (1)