BridgeMD
Tests treatment safety and results for Advanced Non-small Cell Lung Cancer (NSCLC)
Official title Efficacy and Safety of Vorolanib Monotherapy As Third-line or Later Treatment for Advanced Non-small Cell Lung Cancer Patients: a Single-arm, Prospective, Open-label Phase II Clinical Study
ClinicalTrials.gov ID: NCT06728852
What this study is testing
What is Administration of Vorolanib?
Administration of Vorolanib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced non-small cell lung cancer (nsclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study evaluates the efficacy and safety of Vorolanib as monotherapy for advanced non-small cell lung cancer (NSCLC) patients receiving third-line or higher treatments. It is a single-center, single-arm, prospective Phase II clinical trial.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Sign the informed consent
- Pathologically or cytologically diagnosed with metastatic/relapsed advanced NSCLC, with measurable lesions (according to RECIST 1.1)
- Previously received at least two systemic therapies, allowing for third-line or higher chemotherapy or unable to tolerate chemotherapy
- Patients with negative results for driver gene testing or patients with positive results who have already received relevant targeted drugs or...
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Expected survival time ≥ 3 months
You likely can't join if
- Previously failed treatment with multi-target anti-angiogenic drugs, such as anlotinib, cabozantinib, apatinib, lenvatinib, etc. The use of...
- Small cell lung cancer (including small cell carcinoma, non-small cell lung cancer mixed with other types of tumors)
- Testing positive for driver genes but not treated with TKIs
- Tumor invasion of large blood vessels, central squamous cell carcinoma of the lung with cavitation, or non-small cell lung cancer with hemoptysis...
- Accompanied by other types of malignant tumors within the past 5 years or currently
- Planning to receive systemic anti-tumor therapy within 4 weeks before enrollment or during the study period, including cytotoxic therapy, signal...
See the full eligibility criteria
- Sign the informed consent
- Pathologically or cytologically diagnosed with metastatic/relapsed advanced NSCLC, with measurable lesions (according to RECIST 1.1)
- Previously received at least two systemic therapies, allowing for third-line or higher chemotherapy or unable to tolerate chemotherapy
- Patients with negative results for driver gene testing or patients with positive results who have already received relevant targeted drugs or systemic anti-tumor treatments and are either resistant or unable to tolerate...
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Expected survival time ≥ 3 months
- Normal major organ function: renal function with creatinine clearance rate ≥ 60 mL/min; liver function with bilirubin ≤ 1.5× upper limit of normal (ULN), ALT/AST ≤ 2.5× ULN (for patients with documented liver...
- Good hematological function, defined as an absolute neutrophil count (ANC) ≥ 1.5×10\^9/L, platelet count ≥ 100×10\^9/L, hemoglobin ≥ 90g/L (without blood transfusion or erythropoietin [EPO] dependency within the last 7...
- Good coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5× ULN; if the subject is on anticoagulation therapy, PT should be within the intended therapeutic range of the...
- Female patients of childbearing potential must agree to use contraception (e.g., intrauterine device, contraceptives, or condoms) during the study and for 6 months after the study ends; must not be breastfeeding and...
- Patients with well-controlled pleural or peritoneal effusions that do not cause grade 2 or higher respiratory syndrome (≥ CTCAE grade 2) can be included
- Patients without clinical symptoms of intracranial hypertension caused by brain metastases or with brain metastasis symptoms that are stable after prior treatment (radiation therapy or surgery) of brain or meningeal...
- Previously failed treatment with multi-target anti-angiogenic drugs, such as anlotinib, cabozantinib, apatinib, lenvatinib, etc. The use of bevacizumab is allowed, but the last administration must be more than 3 weeks...
- Small cell lung cancer (including small cell carcinoma, non-small cell lung cancer mixed with other types of tumors)
- Testing positive for driver genes but not treated with TKIs
- Tumor invasion of large blood vessels, central squamous cell carcinoma of the lung with cavitation, or non-small cell lung cancer with hemoptysis (\>5ml/day), or where the tumor is likely to invade important blood...
- Accompanied by other types of malignant tumors within the past 5 years or currently
- Planning to receive systemic anti-tumor therapy within 4 weeks before enrollment or during the study period, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy (or mitomycin C within 6 weeks...
- Unremitting toxic reactions caused by previous treatment, CTCAE grade \>1, excluding hair loss
- Various factors affecting oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, bowel obstruction)
- Pleural effusion or ascites leading to respiratory syndrome (≥CTCAE grade 2)
- Symptoms of brain metastasis not controlled and treated within 2 months
- Presence of any severe or uncontrolled disease
- Major surgery, open biopsy, or significant traumatic injury within 28 days before enrollment
- Bleeding diathesis or history of significant bleeding, regardless of severity; any wound, ulcer, or fracture that has not healed following a bleeding or bleeding event (≥CTCAE grade 3)
- Arterial/venous thrombosis within 6 months, such as cerebrovascular accident (including transient ischemic attack), venous thrombosis, pulmonary embolism
- History of substance abuse that cannot be quit or diagnosed with psychiatric disorders
- Participated in other clinical trials of anti-tumor drugs within 4 weeks
- Diagnosed with diseases that severely jeopardize patient safety or affect the completion of this study
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); untreated active hepatitis B; active HCV infection (HCV antibody positive and HCV-RNA levels above detection limit)
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.