Actively Recruiting
PIb/II Open-label Multicenter Study of I.V. Olvi-Vec Combined With Platinum Plus Etoposide in Patients With Advanced Small Cell Lung Cancer Who Are Platinum-Recurrent or Platinum-Refractory
Led by Newsoara HYK Biopharmaceutical (Shanghai) Co., Ltd. · Updated on 2025-12-03
27
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Newsoara HYK Biopharmaceutical (Shanghai) Co., Ltd.
Lead Sponsor
G
Genelux Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating Olvi-Vec, a genetically modified virus originally developed from acne virus, combined with platinum and etoposide chemotherapy in patients with advanced small cell lung cancer (SCLC) who have experienced disease progression or recurrence after platinum-based treatments. This open-label, phase 1/2 study aims to assess the safety, tolerability, and effectiveness of this combination in patients with late-stage SCLC who are platinum-refractory or platinum-recurrent. Olvi-Vec will be given intravenously for 3 consecutive days during the first treatment cycle. Starting from cycle 2, patients will receive platinum (either cisplatin or carboplatin) and etoposide on days 1, 2, and 3 every 21 days. Treatment will continue until disease progression or intolerable side effects. The study includes ongoing monitoring and evaluation during treatment cycles, following standard dosing according to drug labels. Participants will be monitored from enrollment until study completion or withdrawal, up to a maximum of 2 years. Researchers will evaluate safety from the first day through the end of the study. Other assessments include dose-limiting toxicities during the first treatment cycle, objective response rate, disease control rate, and progression-free survival over the study period. Safety and tolerability, as well as treatment responses, will be closely observed throughout the trial.
CONDITIONS
Brief Title
Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign an informed consent form.
- Age 18 years or older, any gender.
- Confirmed diagnosis of small cell lung cancer by pathology or cytology.
- Disease progression or recurrence after platinum-based chemotherapy and/or immunotherapy or other recommended treatments.
- At least one measurable target lesion according to RECIST 1.1 criteria.
- ECOG performance status score of 0 or 1.
- Sufficient bone marrow, liver, and kidney function.
You will not qualify if you...
- Presence of compound or transformed small cell lung cancer.
- Brain metastases with neurological symptoms; stable brain metastases treated locally and symptom-free for over 28 days may be allowed.
- Other primary malignant tumors except certain controlled cancers without recurrence in the past 3 years.
- Clinically significant cardiovascular diseases or unresolved toxicity from prior anti-cancer treatments greater than grade 1.
- Known HIV infection or active hepatitis B or C.
- Receiving chemotherapy, targeted therapy, radiotherapy, or biological therapy within 4 weeks prior to study treatment; local radiotherapy within 2 weeks.
- Major surgery or significant traumatic injury within 28 days prior to first study treatment dose.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years or until disease progression or intolerable toxicity
Participants receive Olvi-Vec for 3 days during the first cycle. Starting from the second cycle, participants receive platinum (cisplatin or carboplatin) and etoposide on days 1, 2, and 3 every 21 days until disease progression or intolerable toxicity occurs.
Cycles every 21 days with treatment on days 1 to 3
Trial Site Locations
Total: 2 locations
1
Zhejiang Provincial People's Hospital
Hangzhou, China
Actively Recruiting
2
Shanghai chest hospital
Shanghai, China
Actively Recruiting
Research Team
H
Hannah Chen
H
Helena zhu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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