Non-Small Cell Lung CancerPhase 1/2NCT07472647
SYS6090 Combination Therapy in Advanced Lung Cancer
A Phase 1/2 study testing SYS6090 + pemetrexed + platinum-based chemotherapy, SYS6090 + paclitaxel + platinum-based chemotherapy and SYS6090 + docetaxel in people with Non-Small Cell Lung Cancer and Small Cell Lung Cancer, run by Shanghai JMT-Bio Inc..
Trial summary
This is an open-label, multi-cohort, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of SYS6090 injection in combination with chemotherapy or chemotherapy and bevacizumab or SYS6010 (an EGFR ADC) in participants with advanced lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer
- What is being tested?
- SYS6090 + pemetrexed + platinum-based chemotherapy, SYS6090 + paclitaxel + platinum-based chemotherapy and SYS6090 + docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2026to 28 Feb 2030
- Phase
- Phase 1/2
- 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
- Voluntarily signed written informed consent.
- Age 18 to 75 years at the time of informed consent, with no restriction on sex.
- Histologically or cytologically confirmed unresectable locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) according to the AJCC/UICC Cancer Staging System, 8th edition, or extensive-stage small cell lung cancer (SCLC), not amenable to curative surgical resection or definitive chemoradiotherapy.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Estimated life expectancy of at least 3 months.
- Has protocol-defined adequate organ and bone marrow function.
Who cannot join
- Use of systemic corticosteroids or other immunosuppressive therapies within 14 days prior to the first dose of study treatment, except for physiologic replacement doses or permitted local, inhaled, or prophylactic use.
- Unresolved > Grade 1 toxicities related to prior anticancer therapy (except for toxicities judged by the investigator to pose no safety risk).
- For Cohorts 5A and 5B: prior permanent discontinuation of EGFR-targeted therapy due to dermatologic toxicity, or presence of dermatologic diseases requiring systemic treatment.
- Known active central nervous system metastases or leptomeningeal metastases, except for stable and adequately treated brain metastases without the need for ongoing corticosteroids or antiepileptic therapy.
- History of interstitial lung disease or non-infectious pneumonitis requiring corticosteroid treatment; current ILD or non-infectious pneumonitis; or inability to exclude these conditions at screening.
- History of severe cardiovascular or cerebrovascular disease.
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- Active or recurrent autoimmune disease requiring systemic treatment, except for clinically stable or well-controlled conditions as specified in the protocol.
- Prior immunotherapy associated with severe immune-related adverse events (≥ Grade 3) or immune-related myocarditis (≥ Grade 2), excluding stable immune-related endocrine disorders.
- Clinically significant bleeding events (≥ Grade 2 according to NCI-CTCAE v6.0) within 4 weeks prior to the first dose of study treatment.
- Arterial or venous thromboembolic events within 6 months prior to the first dose of study treatment, unless judged by the investigator to be clinically stable and low risk.
- Presence of ascites or pleural effusion requiring drainage within 14 days prior to the first dose.
- Known hypersensitivity to any component of the study treatment, history of severe hypersensitivity or infusion-related reactions to protein-based therapies, or poorly controlled asthma.
- Untreated spinal cord compression.
- History of other malignancies within 2 years prior to enrollment or concurrent active malignancy, except for cured localized tumors. -
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 Ib/II Study to Evaluate the Safety, Tolerability, and Efficacy of SYS6090 in Combination With Other Therapies in Participants With Advanced Lung Cancer
This is an open-label, multi-cohort, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of SYS6090 injection in combination with chemotherapy or chemotherapy and bevacizumab or SYS6010 (an EGFR ADC) in participants with advanced lung cancer.
- Conditions
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer
- Being tested
- SYS6090 + pemetrexed + platinum-based chemotherapy, SYS6090 + paclitaxel + platinum-based chemotherapy, SYS6090 + docetaxel, SYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapy, SYS6090 + SYS6010
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6090 + pemetrexed + platinum-based chemotherapyDrug
In this group, participants will receive SYS6090 in combination with pemetrexed and platinum-based chemotherapy.
SYS6090 + paclitaxel + platinum-based chemotherapyDrug
In this group, participants will receive SYS6090 in combination with paclitaxel and platinum-based chemotherapy.
SYS6090 + docetaxelDrug
In this group, participants will receive SYS6090 in combination with docetaxel.
SYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapyDrug
In this group, participants will receive SYS6090 in combination with pemetrexed, bevacizumab, and platinum-based chemotherapy
SYS6090 + SYS6010Drug
In this group, participants will receive SYS6090 and SYS6010.
SYS6090 + etoposide + platinum-based chemotherapyDrug
In this group, participants will receive SYS6090 in combination with etoposide and platinum-based chemotherapy.
SYS6090 + chemotherapy or other anticancer therapyDrug
In this group, participants will receive SYS6090 in combination with chemotherapy or other anticancer therapies.
| Study group | Role | What they receive |
|---|---|---|
| SYS6090 + Pemetrexed + Platinum | Experimental | SYS6090 combined with pemetrexed and platinum-based chemotherapy in participants with driver gene-negative non-squamous non-small cell lung cancer (nsqNSCLC). Receives: Drug: SYS6090 + pemetrexed + platinum-based chemotherapy |
| SYS6090 + Paclitaxel + Platinum | Experimental | SYS6090 combined with paclitaxel and platinum-based chemotherapy in participants with driver gene-negative squamous non-small cell lung cancer (sqNSCLC). Receives: Drug: SYS6090 + paclitaxel + platinum-based chemotherapy |
| SYS6090 + Docetaxel | Experimental | SYS6090 combined with docetaxel in participants with driver gene-negative non-small cell lung cancer (NSCLC). Receives: Drug: SYS6090 + docetaxel |
| SYS6090 + Pemetrexed + Bevacizumab + Platinum | Experimental | SYS6090 combined with pemetrexed, bevacizumab, and platinum-based chemotherapy in participants with driver gene-positive non-squamous non-small cell lung cancer (nsqNSCLC). Receives: Drug: SYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapy |
| SYS6090 + SYS6010 (nsqNSCLC) | Experimental | SYS6090 combined with SYS6010 in participants with driver gene-positive non-squamous non-small cell lung cancer (nsqNSCLC). Receives: Drug: SYS6090 + SYS6010 |
| SYS6090 + SYS6010 (NSCLC) | Experimental | SYS6090 combined with SYS6010 in participants with driver gene-negative non-small cell lung cancer (NSCLC). Receives: Drug: SYS6090 + SYS6010 |
| SYS6090 + Etoposide + Platinum | Experimental | SYS6090 combined with etoposide and platinum-based chemotherapy in participants with small cell lung cancer (SCLC). Receives: Drug: SYS6090 + etoposide + platinum-based chemotherapy |
| SYS6090 + Chemo/Other Anticancer Therapy | Experimental | SYS6090 combined with chemotherapy or other novel anticancer therapies in participants with lung cancer. Receives: Drug: SYS6090 + chemotherapy or other anticancer therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT) (Phase Ib)
To evaluate the safety of SYS6090 in participants.
Measured: Approximately 21 days.
Adverse Events (AEs) (Phase Ib)
To evaluate the safety of SYS6090 combination therapy in participants.
Measured: Up to 90 days after the last administration
Objective response rate (ORR) (Phase II)
ORR is defined as the proportion of participants in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is observed as best overall response.
Measured: Through out the study (up to 2 years)
Secondary outcomes (6)
Cmax of SYS6090 (and SYS6010 if applicable)
To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable).
Measured: Through out the study (up to 2 years)
AUC0-t of SYS6090 (and SYS6010 if applicable)
To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable）
Measured: Through out the study (up to 2 years)
Clearance (CL) of SYS6090 (and SYS6010 if applicable)
To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable)
Measured: Through out the study (up to 2 years)
Other Efficacy Endpoints Assessed by RECIST v1.1 (DoR, DCR, TTR, PFS, and OS)
Evaluation of other efficacy endpoints of SYS6090 combination therapy in participants with advanced lung cancer, assessed by the investigator according to RECIST v1.1, including duration of response (DoR), disease control rate (DCR), time to response (TTR), progression-free survival (PFS), and overall survival (OS).
Measured: Through out the study (up to 2 years)
Adverse Events (AEs) (Phase II)
To evaluate the safety of SYS6090 combination therapy in participants
Measured: Through out the study (up to 2 years)
Correlation between Biomarker Levels and Preliminary Efficacy
The Correlation between Baseline PD-L1 Expression and Antitumor Activity
Measured: Through out the study (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start28 Feb 2026 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2030 (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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 596 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472647
- Sponsor's protocol ID
- SYS6090-004
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Efficacy of SYS6090 in Combination With Other Therapies in Participants With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT07472647
- Acronym / sponsor ID
- SYS6090-004
- Conditions
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 596 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 16 Mar 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 is an open-label, multi-cohort, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of SYS6090 injection in combination with chemotherapy or chemotherapy and bevacizumab or SYS6010 (an EGFR ADC) in participants with advanced lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| SYS6090 + Pemetrexed + Platinum | Experimental | Drug: SYS6090 + pemetrexed + platinum-based chemotherapySYS6090 combined with pemetrexed and platinum-based chemotherapy in participants with driver gene-negative non-squamous non-small cell lung cancer (nsqNSCLC). |
| SYS6090 + Paclitaxel + Platinum | Experimental | Drug: SYS6090 + paclitaxel + platinum-based chemotherapySYS6090 combined with paclitaxel and platinum-based chemotherapy in participants with driver gene-negative squamous non-small cell lung cancer (sqNSCLC). |
| SYS6090 + Docetaxel | Experimental | Drug: SYS6090 + docetaxelSYS6090 combined with docetaxel in participants with driver gene-negative non-small cell lung cancer (NSCLC). |
| SYS6090 + Pemetrexed + Bevacizumab + Platinum | Experimental | Drug: SYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapySYS6090 combined with pemetrexed, bevacizumab, and platinum-based chemotherapy in participants with driver gene-positive non-squamous non-small cell lung cancer (nsqNSCLC). |
| SYS6090 + SYS6010 (nsqNSCLC) | Experimental | Drug: SYS6090 + SYS6010SYS6090 combined with SYS6010 in participants with driver gene-positive non-squamous non-small cell lung cancer (nsqNSCLC). |
| SYS6090 + SYS6010 (NSCLC) | Experimental | Drug: SYS6090 + SYS6010SYS6090 combined with SYS6010 in participants with driver gene-negative non-small cell lung cancer (NSCLC). |
| SYS6090 + Etoposide + Platinum | Experimental | Drug: SYS6090 + etoposide + platinum-based chemotherapySYS6090 combined with etoposide and platinum-based chemotherapy in participants with small cell lung cancer (SCLC). |
| SYS6090 + Chemo/Other Anticancer Therapy | Experimental | Drug: SYS6090 + chemotherapy or other anticancer therapySYS6090 combined with chemotherapy or other novel anticancer therapies in participants with lung cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily signed written informed consent.
- Age 18 to 75 years at the time of informed consent, with no restriction on sex.
- Histologically or cytologically confirmed unresectable locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) according to the AJCC/UICC Cancer Staging System, 8th edition, or extensive-stage small cell lung cancer (SCLC), not amenable to curative surgical resection or definitive chemoradiotherapy.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (14 listed)
- Use of systemic corticosteroids or other immunosuppressive therapies within 14 days prior to the first dose of study treatment, except for physiologic replacement doses or permitted local, inhaled, or prophylactic use.
- Unresolved > Grade 1 toxicities related to prior anticancer therapy (except for toxicities judged by the investigator to pose no safety risk).
- For Cohorts 5A and 5B: prior permanent discontinuation of EGFR-targeted therapy due to dermatologic toxicity, or presence of dermatologic diseases requiring systemic treatment.
- Known active central nervous system metastases or leptomeningeal metastases, except for stable and adequately treated brain metastases without the need for ongoing corticosteroids or antiepileptic therapy.
- History of interstitial lung disease or non-infectious pneumonitis requiring corticosteroid treatment; current ILD or non-infectious pneumonitis; or inability to exclude these conditions at screening.
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 |
|---|---|---|
| SYS6090 + pemetrexed + platinum-based chemotherapyIn this group, participants will receive SYS6090 in combination with pemetrexed and platinum-based chemotherapy. | Drug | SYS6090 + Pemetrexed + Platinum |
| SYS6090 + paclitaxel + platinum-based chemotherapyIn this group, participants will receive SYS6090 in combination with paclitaxel and platinum-based chemotherapy. | Drug | SYS6090 + Paclitaxel + Platinum |
| SYS6090 + docetaxelIn this group, participants will receive SYS6090 in combination with docetaxel. | Drug | SYS6090 + Docetaxel |
| SYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapyIn this group, participants will receive SYS6090 in combination with pemetrexed, bevacizumab, and platinum-based chemotherapy | Drug | SYS6090 + Pemetrexed + Bevacizumab + Platinum |
| SYS6090 + SYS6010In this group, participants will receive SYS6090 and SYS6010. | Drug | SYS6090 + SYS6010 (NSCLC), SYS6090 + SYS6010 (nsqNSCLC) |
| SYS6090 + etoposide + platinum-based chemotherapyIn this group, participants will receive SYS6090 in combination with etoposide and platinum-based chemotherapy. | Drug | SYS6090 + Etoposide + Platinum |
| SYS6090 + chemotherapy or other anticancer therapyIn this group, participants will receive SYS6090 in combination with chemotherapy or other anticancer therapies. | Drug | SYS6090 + Chemo/Other Anticancer Therapy |
Primary outcome
Dose-Limiting Toxicity (DLT) (Phase Ib)
Time frame: Approximately 21 days.
To evaluate the safety of SYS6090 in participants.
Adverse Events (AEs) (Phase Ib)
Time frame: Up to 90 days after the last administration
To evaluate the safety of SYS6090 combination therapy in participants.
Objective response rate (ORR) (Phase II)
Time frame: Through out the study (up to 2 years)
ORR is defined as the proportion of participants in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is observed as best overall response.
6 secondary outcomes
Cmax of SYS6090 (and SYS6010 if applicable)
Time frame: Through out the study (up to 2 years)
AUC0-t of SYS6090 (and SYS6010 if applicable)
Time frame: Through out the study (up to 2 years)
Clearance (CL) of SYS6090 (and SYS6010 if applicable)
Time frame: Through out the study (up to 2 years)
Other Efficacy Endpoints Assessed by RECIST v1.1 (DoR, DCR, TTR, PFS, and OS)
Time frame: Through out the study (up to 2 years)
Adverse Events (AEs) (Phase II)
Time frame: Through out the study (up to 2 years)
Correlation between Biomarker Levels and Preliminary Efficacy
Time frame: Through out the study (up to 2 years)
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 16 Mar 2026.
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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 1/2 study testing SYS6090 + pemetrexed + platinum-based chemotherapy, SYS6090 + paclitaxel + platinum-based chemotherapy and SYS6090 + docetaxel in people with Non-Small Cell Lung Cancer and Small Cell Lung Cancer, run by Shanghai JMT-Bio Inc..
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 14 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 16 Mar 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (Phase Ib) (time frame: Approximately 21 days.). The study lists 3 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 16 Mar 2026.