Squamous Non-Small Cell Lung Cancer sqNSCLCPhase 1NCT07614646
Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 in Combination With Ivonescimab in Sq-NSCLC Patients
A Phase 1 study testing EVM14 and Ivonescimab in people with Squamous Non-Small Cell Lung Cancer sqNSCLC, run by Everest Medicines (Beijing) Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Squamous Non-Small Cell Lung Cancer sqNSCLC
- What is being tested?
- EVM14 and Ivonescimab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- EVM14, Ivonescimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVM14Biological
Cancer Vaccine, Intramuscular (IM) injection at escalating dose levels, administered once every 3 weeks (Q3W)
IvonescimabBiological
Anti PD 1/VEGF bispecific antibody, administered intravenously at a dose of 200 mg once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| EVM14 at Dose Escalation Level plus +Ivonescimab Administered 200mg Q3W | Experimental | Not described Receives: Biological: EVM14; Biological: Ivonescimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT)
Measured: 21days since the 1st EVM14 dose
Incidence and severity of TEAE, TRAE, SAEs, and adverse events (AEs) of Grade ≥ 3
Measured: From first dose until 30±7 days post-last dose
Secondary outcomes (4)
Objective Response Rate(ORR)
Measured: up to 24 months.
Duration of Response(DOR)
Measured: up to 24 months.
Disease Control Rate(DCR)
Measured: up to 24 months.
Progression-Free Survival(PFS)
Measured: up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Non-Small Cell Lung Cancer sqNSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Everest Medicines (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614646
- Sponsor's protocol ID
- EVM14CX01
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07614646
- Acronym / sponsor ID
- EVM14CX01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Everest Medicines (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVM14 at Dose Escalation Level plus +Ivonescimab Administered 200mg Q3W | Experimental | Biological: EVM14, Biological: Ivonescimab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVM14Cancer Vaccine, Intramuscular (IM) injection at escalating dose levels, administered once every 3 weeks (Q3W) | Biological | EVM14 at Dose Escalation Level plus +Ivonescimab Administered 200mg Q3W |
| IvonescimabAnti PD 1/VEGF bispecific antibody, administered intravenously at a dose of 200 mg once every 3 weeks | Biological | EVM14 at Dose Escalation Level plus +Ivonescimab Administered 200mg Q3W |
Primary outcome
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
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Squamous Non-Small Cell Lung Cancer sqNSCLC
RecruitingPhase 1/2
A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors
Locally Advanced or Metastatic Solid Tumors
RecruitingPhase 1/2
First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, as Monotherapy and in Combination With Anticancer Therapy in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer
Advanced Solid Tumors, Breast Cancer Recurrent
RecruitingPhase 1
A Study to Assess the Adverse Events, Change in Disease Activity, and How Oral ABBV-711 Tablets Move Through the Body as a Monotherapy and in Combination With Intravenously Infused Budigalimab (ABBV-181), in Adults With Advanced Squamous Tumors
Advanced Squamous Tumors
RecruitingPhase 4
Metronomic Oral Paclitaxel Plus PD-1/ PD-L1 Inhibitor Maintenance in Advanced Lung Cancer (PULSE Study)
Squamous Non-Small Cell Lung Cancer sqNSCLC, Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Not yet recruitingPhase 2
Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK201 for Injection in Combination With Ivonescimab Injection in sqNSCLC Participants.
NSCLC (Advanced Non-small Cell Lung Cancer)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EVM14 and Ivonescimab in people with Squamous Non-Small Cell Lung Cancer sqNSCLC, run by Everest Medicines (Beijing) Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Everest Clinical Trial Information Center (+86 21 8012 5712, ctinfo.center@everestmedicines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (DLT) (time frame: 21days since the 1st EVM14 dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.