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

NCT07136285 | Recruiting Phase 1

• 1 other identifier: Olvi-Vec-SCLC-202
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

SCLC, Extensive Stage

Outcome Measures

Primary Outcomes (1)

• Evaluate safety of Olvi-Vec in patients from day 1 to end of study

  Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0

  Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.

Secondary Outcomes (4)

• Explore the dose limiting toxicity (DLTs) during day 1 to day 25 of treatment cycle 1

  Day 1 to day 25 of treatment cycle 1

• Objective Response Rate (ORR)

  Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.

• Disease control rate (DCR)

  Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.

• Progression free survival (PFS)

  Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.

Study Arms (1)

Experimental

EXPERIMENTAL

Olvi-Vec will be administered for 3 days in C1, then starting from C2, platinum (platinum (cisplatin or carboplatin)) and episode are administrated each 21 days till patients could not tolerate.

Drug: Olvi-Vec; Drug: platinum (cisplatin or carboplatin); Drug: Etoposide

Interventions

Olvi-Vec DRUG

Olvi-Vec will be administered to patient for 3 days during C1

Experimental

platinum (cisplatin or carboplatin) DRUG

After completing the first cycle of treatment of Olvi-Vec (+21 days after the last dose), Platinum （Carboplatin or Cisplatin）will be administrated on D1,D2 and D3 each 21 days (dosage according to the label) from Cycle 2 until disease progression or intolerable toxicity occurred.

Experimental

Etoposide DRUG

After completing the first cycle of treatment of Olvi-Vec (+21 days after the last dose), Etoposide will be administrated on D1,D2 and D3 each 21 days (dosage according to the label) from Cycle 2 until disease progression or intolerable toxicity occurred.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Newsoara HYK Biopharmaceutical (Shanghai) Co., Ltd.: lead
• Genelux Corporation: collaborator

Study Sites (2)

Zhejiang Provincial People's Hospital

Hangzhou, China

RECRUITING

Shanghai chest hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Platinum; Cisplatin; Carboplatin; Etoposide

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Hannah Chen

CONTACT

+8613801955339; hannah.chen@newsoara.com

Helena zhu

CONTACT

helena.zhu@newsoara.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: August 22, 2025
• Study Start: July 24, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)