SYS6090 Combination Therapy in Advanced Lung Cancer

NCT07472647 | Not Yet Recruiting Phase 1

• 1 other identifier: SYS6090-004
• Study Type: interventional
• Target: 596
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Non-Small Cell Lung Cancer; Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Dose-Limiting Toxicity (DLT) (Phase Ib)

  To evaluate the safety of SYS6090 in participants.

  Approximately 21 days.

• Adverse Events (AEs) (Phase Ib)

  To evaluate the safety of SYS6090 combination therapy in participants.

  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.

  Through out the study (up to 2 years)

Secondary Outcomes (6)

• Cmax of SYS6090 (and SYS6010 if applicable)

  Through out the study (up to 2 years)

• AUC0-t of SYS6090 (and SYS6010 if applicable)

  Through out the study (up to 2 years)

• Clearance (CL) 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)

  Through out the study (up to 2 years)

• Adverse Events (AEs) (Phase II)

  Through out the study (up to 2 years)

Study Arms (8)

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).

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).

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).

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).

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).

Drug: SYS6090 + SYS6010

SYS6090 + SYS6010 (NSCLC)

EXPERIMENTAL

SYS6090 combined with SYS6010 in participants with driver gene-negative non-small cell lung cancer (NSCLC).

Drug: SYS6090 + SYS6010

SYS6090 + Etoposide + Platinum

EXPERIMENTAL

SYS6090 combined with etoposide and platinum-based chemotherapy in participants with small cell lung cancer (SCLC).

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.

Drug: SYS6090 + chemotherapy or other anticancer therapy

Interventions

SYS6090 + pemetrexed + platinum-based chemotherapy DRUG

In this group, participants will receive SYS6090 in combination with pemetrexed and platinum-based chemotherapy.

SYS6090 + Pemetrexed + Platinum

SYS6090 + paclitaxel + platinum-based chemotherapy DRUG

In this group, participants will receive SYS6090 in combination with paclitaxel and platinum-based chemotherapy.

SYS6090 + Paclitaxel + Platinum

SYS6090 + docetaxel DRUG

In this group, participants will receive SYS6090 in combination with docetaxel.

SYS6090 + Docetaxel

SYS6090 + pemetrexed + bevacizumab + platinum-based chemotherapy DRUG

In this group, participants will receive SYS6090 in combination with pemetrexed, bevacizumab, and platinum-based chemotherapy

SYS6090 + Pemetrexed + Bevacizumab + Platinum

SYS6090 + SYS6010 DRUG

In this group, participants will receive SYS6090 and SYS6010.

SYS6090 + SYS6010 (NSCLC); SYS6090 + SYS6010 (nsqNSCLC)

SYS6090 + etoposide + platinum-based chemotherapy DRUG

In this group, participants will receive SYS6090 in combination with etoposide and platinum-based chemotherapy.

SYS6090 + Etoposide + Platinum

SYS6090 + chemotherapy or other anticancer therapy DRUG

In this group, participants will receive SYS6090 in combination with chemotherapy or other anticancer therapies.

SYS6090 + Chemo/Other Anticancer Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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. -

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Pemetrexed; Platinum Compounds; Paclitaxel; Docetaxel; Bevacizumab; Etoposide; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Inorganic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Therapeutics

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: March 16, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-02