SYS6090 Combination Therapy in Advanced Lung Cancer

March 12, 2026 updated by: Shanghai JMT-Bio Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

596

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Clinical Trials Information Group officer
  • Phone Number: 031169085587
  • Email: ctr-contact@cspc.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  11. Presence of ascites or pleural effusion requiring drainage within 14 days prior to the first dose.
  12. 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.
  13. Untreated spinal cord compression.
  14. History of other malignancies within 2 years prior to enrollment or concurrent active malignancy, except for cured localized tumors. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SYS6090 + Pemetrexed + Platinum
SYS6090 combined with pemetrexed and platinum-based chemotherapy in participants with driver gene-negative non-squamous non-small cell lung cancer (nsqNSCLC).
Drug: SYS6090 + pemetrexed + platinum-based chemotherapy
In this group, participants will receive SYS6090 in combination with pemetrexed and platinum-based chemotherapy.
Experimental: SYS6090 + Paclitaxel + Platinum
SYS6090 combined with paclitaxel and platinum-based chemotherapy in participants with driver gene-negative squamous non-small cell lung cancer (sqNSCLC).
Drug: SYS6090 + paclitaxel + platinum-based chemotherapy
In this group, participants will receive SYS6090 in combination with paclitaxel and platinum-based chemotherapy.
Experimental: SYS6090 + Docetaxel
SYS6090 combined with docetaxel in participants with driver gene-negative non-small cell lung cancer (NSCLC).
Drug: SYS6090 + docetaxel
In this group, participants will receive SYS6090 in combination with docetaxel.
Experimental: SYS6090 + Pemetrexed + Bevacizumab + Platinum
SYS6090 combined with pemetrexed, bevacizumab, and platinum-based chemotherapy in participants with driver gene-positive non-squamous non-small cell lung cancer (nsqNSCLC).
Drug: SYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapy
In this group, participants will receive SYS6090 in combination with pemetrexed, bevacizumab, and platinum-based chemotherapy
Experimental: SYS6090 + SYS6010 (nsqNSCLC)
SYS6090 combined with SYS6010 in participants with driver gene-positive non-squamous non-small cell lung cancer (nsqNSCLC).
Drug: SYS6090 + SYS6010
In this group, participants will receive SYS6090 and SYS6010.
Experimental: SYS6090 + SYS6010 (NSCLC)
SYS6090 combined with SYS6010 in participants with driver gene-negative non-small cell lung cancer (NSCLC).
Drug: SYS6090 + SYS6010
In this group, participants will receive SYS6090 and SYS6010.
Experimental: SYS6090 + Etoposide + Platinum
SYS6090 combined with etoposide and platinum-based chemotherapy in participants with small cell lung cancer (SCLC).
Drug: SYS6090 + etoposide + platinum-based chemotherapy
In this group, participants will receive SYS6090 in combination with etoposide and platinum-based chemotherapy.
Experimental: SYS6090 + Chemo/Other Anticancer Therapy
SYS6090 combined with chemotherapy or other novel anticancer therapies in participants with lung cancer.
Drug: SYS6090 + chemotherapy or other anticancer therapy
In this group, participants will receive SYS6090 in combination with chemotherapy or other anticancer therapies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-Limiting Toxicity (DLT) (Phase Ib)
Time Frame: Approximately 21 days.
To evaluate the safety of SYS6090 in participants.
Approximately 21 days.
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.
Up to 90 days after the last administration
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.
Through out the study (up to 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax of SYS6090 (and SYS6010 if applicable)
Time Frame: Through out the study (up to 2 years)
To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable).
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)
To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable）
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)
To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable)
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)
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).
Through out the study (up to 2 years)
Adverse Events (AEs) (Phase II)
Time Frame: Through out the study (up to 2 years)
To evaluate the safety of SYS6090 combination therapy in participants
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)
The Correlation between Baseline PD-L1 Expression and Antitumor Activity
Through out the study (up to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai JMT-Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2026

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2030

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYS6090-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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