Olvi-Vec with platinum plus etoposide for late-stage small cell lung cancer

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

This test tries adding an oncolytic virus called Olvi-Vec to standard platinum-plus-etoposide chemotherapy for people with late-stage small cell lung cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Newsoara HYK Biopharmaceutical (Shanghai) Co., Ltd. (Industry-sponsored)
• Drugs / interventions: anlotinib, chemotherapy, immunotherapy, radiation
• Locations: 2 sites (Hangzhou and 1 other locations)
• Trial ID: NCT07136285 on ClinicalTrials.gov

What this trial studies

This phase 1/2 interventional trial gives an oncolytic virus product, Olvi-Vec, together with platinum (cisplatin or carboplatin) and etoposide to patients with extensive-stage small cell lung cancer who have progressed after prior platinum-based therapy and other guideline-recommended treatments. The study enrolls adults with at least one measurable lesion, ECOG 0–1, and adequate bone marrow, liver, and kidney function. GLP preclinical safety, pharmacology, and toxicology studies for Olvi-Vec have been completed and clinical testing of the agent in other tumor types is ongoing. The trial is designed to collect safety, tolerability, and initial activity data for the combination in this patient population.

Who should consider this trial

Good fit: Adults (≥18) with extensive-stage small cell lung cancer who progressed after prior platinum-based chemotherapy (with or without prior immunotherapy or anlotinib), have at least one measurable lesion, ECOG 0–1, and adequate organ function are ideal candidates.

Not a fit: Patients with mixed or transformed small cell lung cancer, symptomatic brain metastases, poor performance status (ECOG ≥2), or inadequate organ function are unlikely to qualify or receive benefit from this regimen.

Why it matters

Potential benefit: If successful, the Olvi-Vec combination could increase tumor response and potentially prolong progression-free and overall survival compared with chemotherapy alone.

How similar studies have performed: Oncolytic virus approaches have shown benefit in some cancers (for example T-VEC in melanoma), but Olvi-Vec is relatively novel in SCLC and clinical evidence in this disease is limited so far.

Eligibility criteria

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 -

Where this trial is running

Hangzhou and 1 other locations

• Zhejiang Provincial People's Hospital — Hangzhou, China (Recruiting)
• Shanghai chest hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Hannah Chen

Conditions SCLC, Extensive Stage