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RECRUITINGPHASE1/PHASE2

Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLC

PIb/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of I.V. Olvi-Vec Combined With Platinum Plus Etoposide in Patients With Advanced SCLC Who Are Platinum-recurrent or Platinum-refractory

NCT07136285•Newsoara HYK Biopharmaceutical (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

Summary

Oncolytic virus product named Olvi-Vec combined with Platinum plus Etoposide in patients with late phase SCLC

Detailed Description

Olvi-Vec is a genetic engineering modification of acne virus. GLP preclinical studies include the safety, pharmacology, and toxicology have been completed. Clinical studies exploring efficacy and safety in different types of tumor are ongoing.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Able to understand and voluntarily sign an informed consent form.
•Age ≥ 18 years old, gender not limited.
•Small cell lung cancer confirmed by organization or cytology.
•After receiving platinum based chemotherapy regimens and/or immunotherapy, platinum based chemotherapy regimens and/or anlotinib, and other recommended treatments according to guidelines, disease progression or recurrence has occurred.
•There should be at least one measurable target lesion during the baseline period, according to RECIST 1.1 (if a lesion that has received radiation therapy has obvious evidence of disease progression after radiation therapy, it can be used as a target lesion).
•ECOG physical condition score 0 or 1.
•Have sufficient bone marrow, liver and kidney organ function-

Exclusion Criteria

•Compound small cell lung cancer and transformed small cell lung cancer.
•Patients with brain metastases and neurological symptoms; Note: Subjects with previous imaging evidence of brain metastases who have undergone local treatment (such as radiotherapy or surgery) for intracranial metastases and have stable lesions for more than 28 days without symptoms can be enrolled.
•Other primary malignant tumors other than small cell lung cancer (excluding non melanoma skin cancer, breast cancer in situ, cervical cancer in situ, and superficial bladder cancer, or other cancers that have been effectively controlled in the past three years and have no evidence of disease recurrence) were previously or currently combined.
•Clinically significant cardiovascular diseases At the beginning of the study treatment, the toxicity associated with previous anti-tumor treatments did not recover to ≤ CTCAE grade 1, except for hair loss and peripheral neurotoxicity of CTCAE grade 2.
•Known HIV infection (HIV antibody positive), active hepatitis B and C patients.
•Receive chemotherapy, targeted therapy, radiotherapy, and biological therapy, with less than 4 weeks since the first administration in this study; Or have received local radiotherapy within 2 weeks.
•Having undergone major surgery or significant traumatic injury within 28 days prior to the first administration of the investigational drug -

Locations (2)

Zhejiang Provincial People's Hospital

Hangzhou, China

Shanghai chest hospital

Shanghai, China

Key Dates

Start Date

July 24, 2023

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

December 3, 2025

Enrollment

ESTIMATED participants

Conditions

SCLC, Extensive Stage

Interventions

Olvi-Vec

DRUG

platinum (cisplatin or carboplatin)

DRUG

Etoposide

DRUG

Contacts

Hannah Chen

CONTACT

+8613801955339 hannah.chen@newsoara.com

Helena zhu

CONTACT

helena.zhu@newsoara.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLC

Inclusion Criteria

Exclusion Criteria

A Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors

Real-World Study of Toripalimab in Extensive-Stage Small Cell Lung Cancer

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Alotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer

Utidelone in Third-line and Above Treatment of Small Cell Lung Cancer