Recruiting NCT07136285
Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Olvi-Vec, platinum (cisplatin or carboplatin), Etoposide.
- Who it may be relevant to
- Registry conditions: SCLC, Extensive Stage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Olvi-Vec
Olvi-Vec will be administered to patient for 3 days during C1 - Drug platinum (cisplatin or carboplatin)
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. - Drug Etoposide
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.
Primary outcome measures
- Evaluate safety of Olvi-Vec in patients from day 1 to end of study [Time frame: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.]
Secondary outcome measures (4)
- Explore the dose limiting toxicity (DLTs) during day 1 to day 25 of treatment cycle 1 [Time frame: Day 1 to day 25 of treatment cycle 1]
- Objective Response Rate (ORR) [Time frame: 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) [Time frame: 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) [Time frame: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.]
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 -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Zhejiang Provincial People's Hospital — Hangzhou
- Shanghai chest hospital — Shanghai
Identifiers
NCT: NCT07136285 · Olvi-Vec-SCLC-202