NCT07136285 Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLC
| NCT ID | NCT07136285 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Newsoara HYK Biopharmaceutical (Shanghai) Co., Ltd. |
| Condition | SCLC, Extensive Stage |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2023-07-24 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2023-07-24 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Oncolytic virus product named Olvi-Vec combined with Platinum plus Etoposide in patients with late phase SCLC
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 -
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07136285 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying SCLC, Extensive Stage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07136285 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07136285 currently recruiting?
Yes, NCT07136285 is actively recruiting participants. Contact the research team at hannah.chen@newsoara.com for enrollment information.
Where is the NCT07136285 trial being conducted?
This trial is being conducted at Hangzhou, China, Shanghai, China.
Who is sponsoring the NCT07136285 clinical trial?
NCT07136285 is sponsored by Newsoara HYK Biopharmaceutical (Shanghai) Co., Ltd.. The trial plans to enroll 27 participants.