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Not yet recruiting NCT07614646

Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 in Combination With Ivonescimab in Sq-NSCLC Patients

Phase I Interventional Squamous Non-Small Cell Lung Cancer sqNSCLC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EVM14, Ivonescimab.
Who it may be relevant to
Registry conditions: Squamous Non-Small Cell Lung Cancer sqNSCLC. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase Ia Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Combined With Ivonescimab in Patients With Squamous Non-Small Cell Lung Cancer

Overview

The purpose of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of EVM14 administered intramuscularly (IM) combination with Ivonescimab in patients with sq-NSCLC.

Interventions

  • Biological EVM14
    Cancer Vaccine, Intramuscular (IM) injection at escalating dose levels, administered once every 3 weeks (Q3W)
  • Biological Ivonescimab
    Anti PD 1/VEGF bispecific antibody, administered intravenously at a dose of 200 mg once every 3 weeks

Primary outcome measures

  • Incidence of dose-limiting toxicity (DLT) [Time frame: 21days since the 1st EVM14 dose]
  • Incidence and severity of TEAE, TRAE, SAEs, and adverse events (AEs) of Grade ≥ 3 [Time frame: From first dose until 30±7 days post-last dose]
Secondary outcome measures (4)
  • Objective Response Rate(ORR) [Time frame: up to 24 months.]
  • Duration of Response(DOR) [Time frame: up to 24 months.]
  • Disease Control Rate(DCR) [Time frame: up to 24 months.]
  • Progression-Free Survival(PFS) [Time frame: up to 24 months.]

Eligibility criteria

Inclusion criteria

  • Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous non-small-cell lung cancer (sq-NSCLC), which is unresectable or not curable by definitive concurrent/sequential chemoradiotherapy.
  • Known positive PD-L1 expression in tumor tissue prior to enrollment, with Tumor Proportion Score (TPS) ≥ 1% assessed via the 22C3 assay.
  • No prior systemic anti-tumor therapy. Neoadjuvant/adjuvant systemic chemoradiotherapy for curative intent in non-metastatic disease, or definitive concurrent/sequential chemoradiotherapy for locally advanced disease, are permitted, provided disease progression occurs ≥ 6 months after the last treatment.
  • Patients with at least 1 measurable lesion as defined per RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
  • Life expectancy ≥ 6 months.
  • Patients must have adequate organ function.

Exclusion criteria

  • Has disease that is suitable for local treatment administered with curative intent.
  • Cannot provide sufficient tumor slides for biomarker testing.
  • Has a diagnosed and/or treated additional malignancy within 5 years prior to the first dose of study treatment except for: curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, and curatively resected in situ breast, cervical cancer, and prostate cancer.
  • Active central nervous system (CNS) metastases. Patients with clinically stable brain metastases are eligible for enrollment.
  • Has active autoimmune disease that has required systemic treatment in past 2 years or history of autoimmune disease that has possibility of relapse or at risk of having these conditions.
  • Has received prior systemic anti-angiogenic therapy or any tumor-directed immunotherapy
  • The left ventricular ejection fraction (LVEF) < 50% during the screening period.
  • Patients known to be human immunodeficiency virus (HIV)-positive.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07614646 · EVM14CX01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗