Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06980272

SSGJ-707 in Advanced Non-Small Cell Lung Cancer

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%.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SSGJ-707

Drug

Subjects receive SSGJ-707 intravenously.

Pembrolizumab

Drug

Subjects receive Pembrolizumab intravenously.

Primary outcomes

  1. PFS assessed by IRRC per RECIST v1.1

    Time frame: Up to 2 approximately years

    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).

Secondary outcomes

  1. OS

    Time frame: Up to 2 approximately years

    Overall Survival (OS) is defined as the time from the start of treatment with SSGJ-707 until death due to any cause.

  2. ORR assessed by IRRC per RECIST v1.1

    Time frame: Up to 2 approximately years

    ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

  3. DoR assessed by IRRC per RECIST v1.1

    Time frame: Up to 2 approximately years

    Duration of response (DoR) assessed according to RECIST v1.1.

  4. DCR assessed by IRRC per RECIST v1.1

    Time frame: Up to 2 approximately years

    Disease control rate (DCR) assessed according to RECIST v1.1.

  5. TTR assessed by IRRC per RECIST v1.1

    Time frame: Up to 2 approximately years

    Time to response (TTR) is defined as the time to response base on RECIST v1.1.

  6. PFS assessed by investigator per RECIST v1.1

    Time frame: Up to 2 approximately years

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

  7. ORR assessed by the investigator per RECIST v1.1

    Time frame: Up to 2 approximately years

    ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

  8. DoR assessed by the investigator per RECIST v1.1

    Time frame: Up to 2 approximately years

    Duration of response (DoR) assessed according to RECIST v1.1.

  9. DCR assessed by the investigator per RECIST v1.1

    Time frame: Up to 2 approximately years

    Disease control rate (DCR) assessed according to RECIST v1.1.

  10. TTR assessed by the investigator per RECIST v1.1

    Time frame: Up to 2 approximately years

    Time to response (TTR) is defined as the time to response base on RECIST v1.1.

  11. AE

    Time frame: Up to 2 approximately years

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  12. ADA

    Time frame: Up to 2 approximately years

    Number of subjects with detectable anti-drug antibodies (ADA).

  13. PD-L1 expression

    Time frame: Up to 2 approximately years

    The correlationship between PD-L1 expression and SSGJ-707 anti-tumor activity.

Study contacts

Contact information is provided by the study sponsor or research team.

Caicun Zhou

CONTACT

[email protected]

13301825532

Sponsors and collaborators

Lead sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Industry

Registry information

Official study title

A Randomized Controlled, Multi-center Phase III Clinical Trial of SSGJ-707 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
May 20, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.