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SYS6090 Combination Therapy in Advanced Lung Cancer | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

SYS6090 Combination Therapy in Advanced Lung Cancer

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

NCT07472647•Shanghai JMT-Bio Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily signed written informed consent.
•2. Age 18 to 75 years at the time of informed consent, with no restriction on sex.
•3. 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.
•4. At least one measurable lesion according to RECIST v1.1.
•5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•6. Estimated life expectancy of at least 3 months.
•7. Has protocol-defined adequate organ and bone marrow function.

Exclusion Criteria

•1. 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.
•2. Unresolved \> Grade 1 toxicities related to prior anticancer therapy (except for toxicities judged by the investigator to pose no safety risk).
•3. For Cohorts 5A and 5B: prior permanent discontinuation of EGFR-targeted therapy due to dermatologic toxicity, or presence of dermatologic diseases requiring systemic treatment.
•4. 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.
•5. 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.
•6. History of severe cardiovascular or cerebrovascular disease.
•7. Active or recurrent autoimmune disease requiring systemic treatment, except for clinically stable or well-controlled conditions as specified in the protocol.
•8. Prior immunotherapy associated with severe immune-related adverse events (≥ Grade 3) or immune-related myocarditis (≥ Grade 2), excluding stable immune-related endocrine disorders.
•9. Clinically significant bleeding events (≥ Grade 2 according to NCI-CTCAE v6.0) within 4 weeks prior to the first dose of study treatment.
•10. 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.
+4 more criteria

Key Dates

Start Date

February 28, 2026

Primary Completion Date

February 28, 2029

Completion Date

February 28, 2030

Last Updated

March 16, 2026

Enrollment

596

ESTIMATED participants

Conditions

Non-Small Cell Lung CancerSmall Cell Lung Cancer

Interventions

SYS6090 + pemetrexed + platinum-based chemotherapy

DRUG

SYS6090 + paclitaxel + platinum-based chemotherapy

DRUG

SYS6090 + docetaxel

DRUG

SYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapy

DRUG

SYS6090 + SYS6010

DRUG

SYS6090 + etoposide + platinum-based chemotherapy

DRUG

SYS6090 + chemotherapy or other anticancer therapy

DRUG

Contacts

Clinical Trials Information Group officer

CONTACT

031169085587 ctr-contact@cspc.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SYS6090 Combination Therapy in Advanced Lung Cancer

Inclusion Criteria

Exclusion Criteria

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