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Advanced Non-Small Cell Lung CancerPhase 3NCT06980272

SSGJ-707 in Advanced Non-Small Cell Lung Cancer

A Phase 3 study testing SSGJ-707 and Pembrolizumab in people with Advanced Non-Small Cell Lung Cancer, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Non-Small Cell Lung Cancer
What is being tested?
SSGJ-707 and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
1 siteChina
Study dates
20 Jun 2025to 31 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Caicun Zhou contact

13301825532

caicunzhoudr@tongji.edu.cn

China1 site, 1 recruiting

  • The Shanghai East Hospital

    Shanghai

    The Shanghai East Hospital, 021-38804518-22198, siwei_bao@163.com

    Recruiting

Other trials in China

About this study

Official 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

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%.

Being tested
SSGJ-707, Pembrolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SSGJ-707Drug

    Subjects receive SSGJ-707 intravenously.

  • PembrolizumabDrug

    Subjects receive Pembrolizumab intravenously.

Study groups in NCT06980272
Study groupRoleWhat they receive
SSGJ-707ExperimentalSubjects receive SSGJ-707 monotherapy intravenously (IV), selected dose.
Receives: Drug: SSGJ-707
PembrolizumabActive comparatorSubjects receive Pembrolizumab monotherapy intravenously (IV), 200mg q3w.
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 2 approximately years

Secondary outcomes (13)

  1. OS

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

    Measured: Up to 2 approximately years

  2. ORR assessed by IRRC per RECIST v1.1

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

    Measured: Up to 2 approximately years

  3. DoR assessed by IRRC per RECIST v1.1

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

    Measured: Up to 2 approximately years

  4. DCR assessed by IRRC per RECIST v1.1

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

    Measured: Up to 2 approximately years

  5. TTR assessed by IRRC per RECIST v1.1

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

    Measured: Up to 2 approximately years

  6. PFS assessed by investigator 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 assessed by the investigator or death due to any cause (whichever occurs first).

    Measured: Up to 2 approximately years

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

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

    Measured: Up to 2 approximately years

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

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

    Measured: Up to 2 approximately years

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

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

    Measured: Up to 2 approximately years

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

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

    Measured: Up to 2 approximately years

  11. AE

    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.

    Measured: Up to 2 approximately years

  12. ADA

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

    Measured: Up to 2 approximately years

  13. PD-L1 expression

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

    Measured: Up to 2 approximately years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2025
  2. Study start20 Jun 2025
  3. Primary completion30 Jul 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06980272
Sponsor's protocol ID
SSGJ-707-NSCLC-III-01
Status last verified
May 2025
First submitted
12 May 2025
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SSGJ-707 and Pembrolizumab in people with Advanced Non-Small Cell Lung Cancer, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Caicun Zhou (13301825532, caicunzhoudr@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS assessed by IRRC per RECIST v1.1 (time frame: Up to 2 approximately years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06980272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.

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