New vaccine combo takes on tough lung cancer in early trial
NCT ID NCT07614646
First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This early-phase study tests a new cancer vaccine (EVM14) combined with an immunotherapy drug (ivonescimab) in 13 people with advanced squamous non-small cell lung cancer that has not been treated before. The main goals are to check safety and find the right dose, while also looking at whether the tumors shrink or stop growing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EVM14 (cancer vaccine) and ivonescimab (immunotherapy)
- What this could lead to
- If successful, this combination could offer a new treatment option for advanced squamous non-small cell lung cancer, potentially improving tumor control.
- What could go wrong
- This is a very early, small Phase 1 trial focused on safety, not proof of effectiveness. The vaccine may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 13 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. Known positive PD-L1 expression in tumor tissue prior to enrollment, with Tumor Proportion Score (TPS) ≥ 1% assessed via the 22C3 assay. 3. 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. 4. Patients with at least 1 measurable lesion as defined per RECIST v1.1. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. 6. Life expectancy ≥ 6 months. 7. Patients must have adequate organ function. Exclusion Criteria: 1. Has disease that is suitable for local treatment administered with curative intent. 2. Cannot provide sufficient tumor slides for biomarker testing. 3. 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. 4. Active central nervous system (CNS) metastases. Patients with clinically stable brain metastases are eligible for enrollment. 5. 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. 6. Has received prior systemic anti-angiogenic therapy or any tumor-directed immunotherapy 7. The left ventricular ejection fraction (LVEF) \< 50% during the screening period. 8. Patients known to be human immunodeficiency virus (HIV)-positive.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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