First-line Advanced NSCLC PatientsPhase 2NCT07171606
A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients
A Phase 2 study testing SSGJ-706, pemetrexed /carboplatin and Carboplatin/Paclitaxel in people with First-line Advanced NSCLC Patients, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- First-line Advanced NSCLC Patients
- What is being tested?
- SSGJ-706, pemetrexed /carboplatin and Carboplatin/Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2025to 31 Aug 2027
- 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
- Histologically and/or cytologically documented local advanced or metastatic NSCLC .
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >=3 months.
- Signed informed consent form.
Who cannot join
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.5.0).
- Inadequate organ or bone marrow function.
- Pregnant or breast-feeding woman.
- Known allergies, hypersensitivity, or intolerance to SSGJ-706
- 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.
China1 site, 1 recruiting
- Recruiting
Institute of The Shanghai Pulmonary Hospital
Shanghai
Shengxiang Ren, 13816756732, harry_ren@126.com
About this study
This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC
Read the detailed description
This study is a study of SSGJ-706 monotherapy and combination therapy for advanced NSCLC Patients. This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced NSCLC Patients.
- Conditions
- First-line Advanced NSCLC Patients
- Being tested
- SSGJ-706, pemetrexed /carboplatin, Carboplatin/Paclitaxel, PD-1 Inhibitor + Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-706Drug
PD-1/PD-L1 bispecific antibody
pemetrexed /carboplatinDrug
chemotherapy
Carboplatin/PaclitaxelDrug
chemotherapy
PD-1 Inhibitor + ChemotherapyDrug
control group
| Study group | Role | What they receive |
|---|---|---|
| dose level 1 of SSGJ-706 monotherapy | Experimental | Not described Receives: Drug: SSGJ-706 |
| dose level 2 of SSGJ-706 monotherapy | Experimental | Not described Receives: Drug: SSGJ-706 |
| dose level 1 of SSGJ-706 combined with chemotherapy | Experimental | Not described Receives: Drug: SSGJ-706; Drug: pemetrexed /carboplatin |
| dose level 2 of SSGJ-706 combined with chemotherapy | Experimental | Not described Receives: Drug: SSGJ-706; Drug: Carboplatin/Paclitaxel |
| PD-1/L1 combined with chemotherapy | Active comparator | Not described Receives: Drug: PD-1 Inhibitor + Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: 12 months
Incidence and severity of Adverse Events
Measured: 12 months
Secondary outcomes (5)
DCR : Disease Control Rate
Measured: 12 months
PFS：Progression-Free Survival
Measured: 24 month
OS：Overall Survival
Measured: 24 month
The blood concentration of SSGJ-706
Measured: Approximately 6 months
The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab)
Measured: Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start24 Oct 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First-line Advanced NSCLC PatientsStudies 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
- 240 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
- NCT07171606
- Sponsor's protocol ID
- SSGJ-706-201
- Status last verified
- Aug 2025
- First submitted
- 1 Sep 2025
- Last updated
- 18 Dec 2025
- 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients
- ClinicalTrials.gov ID
- NCT07171606
- Acronym / sponsor ID
- SSGJ-706-201
- Conditions
- First-line Advanced NSCLC Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 12 Sep 2025 (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 includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC
Detailed description
This study is a study of SSGJ-706 monotherapy and combination therapy for advanced NSCLC Patients. This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced NSCLC Patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| dose level 1 of SSGJ-706 monotherapy | Experimental | Drug: SSGJ-706 |
| dose level 2 of SSGJ-706 monotherapy | Experimental | Drug: SSGJ-706 |
| dose level 1 of SSGJ-706 combined with chemotherapy | Experimental | Drug: SSGJ-706, Drug: pemetrexed /carboplatin |
| dose level 2 of SSGJ-706 combined with chemotherapy | Experimental | Drug: SSGJ-706, Drug: Carboplatin/Paclitaxel |
| PD-1/L1 combined with chemotherapy | Active comparator | Drug: PD-1 Inhibitor + Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and/or females over age 18
- Histologically and/or cytologically documented local advanced or metastatic NSCLC .
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >=3 months.
- Signed informed consent form.
Key exclusion criteria (6 listed)
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.5.0).
- Inadequate organ or bone marrow function.
- Pregnant or breast-feeding woman.
- Known allergies, hypersensitivity, or intolerance to SSGJ-706
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-706PD-1/PD-L1 bispecific antibody | Drug | dose level 1 of SSGJ-706 combined with chemotherapy, dose level 1 of SSGJ-706 monotherapy, dose level 2 of SSGJ-706 combined with chemotherapy, dose level 2 of SSGJ-706 monotherapy |
| pemetrexed /carboplatinchemotherapy | Drug | dose level 1 of SSGJ-706 combined with chemotherapy |
| Carboplatin/Paclitaxelchemotherapy | Drug | dose level 2 of SSGJ-706 combined with chemotherapy |
| PD-1 Inhibitor + Chemotherapycontrol group | Drug | PD-1/L1 combined with chemotherapy |
Primary outcome
Objective response rate (ORR)
Time frame: 12 months
Incidence and severity of Adverse Events
Time frame: 12 months
5 secondary outcomes
DCR : Disease Control Rate
Time frame: 12 months
PFS：Progression-Free Survival
Time frame: 24 month
OS：Overall Survival
Time frame: 24 month
The blood concentration of SSGJ-706
Time frame: Approximately 6 months
The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab)
Time frame: Approximately 6 months
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 18 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for First-line Advanced NSCLC Patients
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
RecruitingPhase 3
A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Non-small Cell Lung Cancer, HER2 Mutation
RecruitingPhase 3
Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
Active, not recruitingPhase 3
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 3
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SSGJ-706, pemetrexed /carboplatin and Carboplatin/Paclitaxel in people with First-line Advanced NSCLC Patients, 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 5 inclusion and 6 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 18 Dec 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 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 Shengxiang Ren (13816756732, harry_ren@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 12 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 18 Dec 2025.