NCT07614646Not yet recruitingPhase 1
Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 in Combination With Ivonescimab in Sq-NSCLC Patients
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- First submitted
- 20 May 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Everest Medicines (Beijing) Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07614646
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 13
- From 1 Nov 2026 to the primary completion date, 31 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Has received prior systemic anti-angiogenic therapy or any tumor-directed immunotherapy
Other illness
- Has disease that is suitable for local treatment administered with curative intent.
- 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.
- Patients known to be human immunodeficiency virus (HIV)-positive.
Lab values
- The left ventricular ejection fraction (LVEF) \< 50% during the screening period.
Other
- Cannot provide sufficient tumor slides for biomarker testing.
- Active central nervous system (CNS) metastases. Patients with clinically stable brain metastases are eligible for enrollment.
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.