Non Small Cell Lung CancerPhase 2NCT07874984
SPGL008 in Combination With SSGJ-706 ± Chemotherapy for Advanced Non-small Cell Lung Cancer
A Phase 2 study testing SSGJ-706, SPGL008 and Chemotherapy in people with Non Small Cell Lung Cancer, run by Shenyang Sunshine Pharmaceutical Co., LTD..
Trial summary
This study is an open, multicenter, phase 2 clinical trial of SPGL008 in combination with SSGJ-706 ± chemotherapy for the treatment of advanced non-small cell lung cancer. The objective is to evaluate the safety and efficacy of SPGL008 combined with SSGJ-706 in participants with driver gene-negative advanced non-small… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- SSGJ-706, SPGL008 and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2029
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and/or females over age 18-75
- Histologically and/or cytologically documented local advanced or metastatic NSCLC .
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >=3 months.
- Adequate organ or bone marrow function.
- Signed informed consent form.
Who cannot join
- Known positive driver genes
- Pregnant or breast-feeding woman.
- Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria
- Known allergies, hypersensitivity, or intolerance to SSGJ-706/SPGL008 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2 Study of SPGL008 in Combination With SSGJ-706 ± Chemotherapy for Advanced Non-small Cell Lung Cancer
This study is an open, multicenter, phase 2 clinical trial of SPGL008 in combination with SSGJ-706 ± chemotherapy for the treatment of advanced non-small cell lung cancer. The objective is to evaluate the safety and efficacy of SPGL008 combined with SSGJ-706 in participants with driver gene-negative advanced non-small cell lung cancer.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- SSGJ-706, SPGL008, Chemotherapy
- Keywords
- Non Small Cell Lung Cancer, PD-1/PD-L1, B7-H3, IL-15
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-706Biological
SSGJ-706 is a bispecific antibody that targets both human PD-1 and PD-L1
SPGL008Biological
SPGL008 is a dual-functional molecule that combines an anti-B7-H3 monoclonal antibody with IL-15Rα sushi / IL-15.
ChemotherapyDrug
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| SPGL0008 dose1/2+SSGJ-706 selected dose | Experimental | Not described Receives: Biological: SSGJ-706; Biological: SPGL008 |
| SPGL0008 selected dose+SSGJ-706 selected dose | Experimental | Not described Receives: Biological: SSGJ-706; Biological: SPGL008 |
| SPGL0008 selected dose+SSGJ-706 selected dose+chemotherapy | Experimental | Not described Receives: Biological: SSGJ-706; Biological: SPGL008; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events(AEs) assessed by NCI-CTCAE v6.0
Collect and analyze the incidence of adverse events to evaluate safety and tolerability per NCI-CTCAE v6.0
Measured: 24 months
Objective Response Rate(ORR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: 24 months
Secondary outcomes (6)
Maximum Plasma Concentration (Cmax)
Collect blood samples at the preset time points, measure the concentrations, draw the concentration-time curve, and select the highest point on the curve.
Measured: 24 months
Area under the curve (AUC)
Based on the concentrations at multiple time points and the time
Measured: 24months
Half-life (T1/2)
Calculate the half-life based on the concentration of the collected data.
Measured: 24months
Lymphocytes
Calculate and analyze the relationship between lymphocytes and efficacy
Measured: 24months
Immunogenicity
Subjects will be tested for anti-drug antibody (ADA), and ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb).
Measured: 24months
Cytokines
Calculate and analyze the relationship between cytokines and efficacy
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874984
- Sponsor's protocol ID
- SPGL008-201
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of SPGL008 in Combination With SSGJ-706 ± Chemotherapy for Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07874984
- Acronym / sponsor ID
- SPGL008-201
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, PD-1/PD-L1, B7-H3, IL-15
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open, multicenter, phase 2 clinical trial of SPGL008 in combination with SSGJ-706 ± chemotherapy for the treatment of advanced non-small cell lung cancer. The objective is to evaluate the safety and efficacy of SPGL008 combined with SSGJ-706 in participants with driver gene-negative advanced non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SPGL0008 dose1/2+SSGJ-706 selected dose | Experimental | Biological: SSGJ-706, Biological: SPGL008 |
| SPGL0008 selected dose+SSGJ-706 selected dose | Experimental | Biological: SSGJ-706, Biological: SPGL008 |
| SPGL0008 selected dose+SSGJ-706 selected dose+chemotherapy | Experimental | Biological: SSGJ-706, Biological: SPGL008, Drug: Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and/or females over age 18-75
- Histologically and/or cytologically documented local advanced or metastatic NSCLC .
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >=3 months.
- Adequate organ or bone marrow function.
Key exclusion criteria (4 listed)
- Known positive driver genes
- Pregnant or breast-feeding woman.
- Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria
- Known allergies, hypersensitivity, or intolerance to SSGJ-706/SPGL008 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSGJ-706SSGJ-706 is a bispecific antibody that targets both human PD-1 and PD-L1 | Biological | SPGL0008 dose1/2+SSGJ-706 selected dose, SPGL0008 selected dose+SSGJ-706 selected dose, SPGL0008 selected dose+SSGJ-706 selected dose+chemotherapy |
| SPGL008SPGL008 is a dual-functional molecule that combines an anti-B7-H3 monoclonal antibody with IL-15Rα sushi / IL-15. | Biological | SPGL0008 dose1/2+SSGJ-706 selected dose, SPGL0008 selected dose+SSGJ-706 selected dose, SPGL0008 selected dose+SSGJ-706 selected dose+chemotherapy |
| ChemotherapyChemotherapy | Drug | SPGL0008 selected dose+SSGJ-706 selected dose+chemotherapy |
Primary outcome
Incidence of Adverse Events(AEs) assessed by NCI-CTCAE v6.0
Time frame: 24 months
Collect and analyze the incidence of adverse events to evaluate safety and tolerability per NCI-CTCAE v6.0
Objective Response Rate(ORR)
Time frame: 24 months
The efficacy of solid tumors was evaluated according to RECIST v1.1
6 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: 24 months
Area under the curve (AUC)
Time frame: 24months
Half-life (T1/2)
Time frame: 24months
Lymphocytes
Time frame: 24months
Immunogenicity
Time frame: 24months
Cytokines
Time frame: 24months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SSGJ-706, SPGL008 and Chemotherapy in people with Non Small Cell Lung Cancer, run by Shenyang Sunshine Pharmaceutical Co., LTD..
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 LIN WU (86+13170419973, wulin-calf@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events(AEs) assessed by NCI-CTCAE v6.0 (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.