Treatment for advanced non-small cell lung cancer using PVT-1
Efficacy and Safety of PVT-1 Treatment in Patients With Advanced and Refractory Non-Small Cell Lung Cancer
This study is testing a new oral drug called PVT-1 to see if it can help patients with advanced non-small cell lung cancer who haven't responded to other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | PlusVitech S.L. Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Adana and 3 other locations) |
| Trial ID | NCT04840004 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of PVT-1, an orally administered drug, in patients with advanced non-small cell lung cancer (NSCLC) who have a specific molecular profile and are refractory to existing treatments. The study focuses on patients with NSCLC that is EGFR-, ALK-, and ROS1-negative, targeting those who have limited treatment options. Participants will be monitored for disease progression and treatment response through imaging assessments. The trial aims to address the unmet medical need in this patient population by providing a potential new therapeutic option.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with advanced, refractory non-small cell lung cancer that is EGFR-, ALK-, and ROS1-negative.
Not a fit: Patients with untreated or symptomatic brain metastases or those who are not refractory to existing treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new option for patients with advanced NSCLC who have exhausted standard therapies.
How similar studies have performed: While there have been studies targeting similar patient populations, the specific approach with PVT-1 represents a novel intervention in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Female or male with age \> 18 years' old Personally signed and dated informed consent that indicating that the participant ( or a legal representative) has been informed of all aspects of the study Histologically or cytologically confirmed non-small cell lung cancer(NSCLC) NSCLC patients who are not suitable for surgery or radical radiotherapy or chemotherapy, or who have failed to or are intolerable for standard treatment in local advanced or metastatic NSCLC Diagnosis of a metastatic or locally advanced NSCLC with molecular profile EGFR (-), ALK (-) and ROS-1 (-), refractory to existing treatments Evidence of disease radiological measurable. Defined as at least one target lesion that can be accurately measured by imaging, at least one dimension as ≥20 mm with conventional computed tomography (CT), ≥10 mm with spiral CT scan (≥15mm for lymph node) Absence of untreated or symptomatic brain metastases or that requires the use of steroids. Life expectancy of at least three months in the opinion of investigators ECOG performance status of 0-1 Time since last treatment received: 3 weeks from last QT cycle or 6 weeks if nitrosiureas, at least 2 weeks from the last RT session before the first administration of study drug (The administration of palliative radiotherapy for bone pain is allowed by any time) Laboratory results required at the screening visit: Neutrophils\> 1500 / mm3 Haemoglobin\> 9.0g / dl Platelets\> 100,000 / mm3 Total bilirubin \<1.5 times above the normal ranges Transaminases: AST, ALT \<2 times above the normal ranges, If there are liver metastases \<5 times above normal values. Serum creatinine \<1.5 times above the normal ranges Female participants childbearing potential, must have a negative pregnancy test Exclusion Criteria: Pregnant female patients, Breastfeeding female patients Patients unable to meet the requirements (inclusion criteria) of the study Know hypersensitivity, history of allergic or anaphylactic reaction to the drug. ECOG performance status ≥2 Any acute, chronic or psychiatric medical condition or laboratory abnormality that may increase the risk associated with the participation or PVT-1 administration in the study or may interfere with interpretation of the results, and in judgment of the investigator, would make the participant inappropriate for entry into this study. Current history of alcoholism or drug addiction to DSM-IV criteria within 12 months prior to screening. Patients with major organ dysfunctions and heart disease Patients with active tuberculosis Participation in any other clinical studies (phases I - IV) within 1 month or 5 half-lives, or participation in any clinical study of drugs that could present interaction within 1 year of screening visit. Subjects who are directly involved in the conduct of the study, and their family members, site staff members supervised by study investigators.
Where this trial is running
Adana and 3 other locations
- Baskent University — Adana, Turkey (Recruiting)
- Gazi University — Ankara, Turkey (Recruiting)
- Yeditepe University Hospital — Istanbul, Turkey (Recruiting)
- 19 May|s University — Samsun, Turkey (Recruiting)
Study contacts
- Principal investigator: Sahin Lacin — Yeditepe University
- Study coordinator: Sahin Lacin, MD, PhD
- Email: sahin.lacin@yeditepe.edu.tr
- Phone: +902124447000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.