Table of Contents
- Clinical trials overview
- Non-small cell lung cancer studies
- Breast cancer studies
- Other cancer studies
- Trial phases and what they mean
- Main outcomes being measured
- Who may take part
Clinical trials overview
These studies investigate Vinorelbine Tartrate in different cancer trials, often as part of combination treatment plans.[1][2][3] The trials include both adult and pediatric populations, and they cover early-stage, locally advanced, relapsed, and metastatic disease.[1][3]
The studies are interventional, which means the researchers give a treatment and then measure what happens.[1][2] Some trials compare Vinorelbine Tartrate with other treatment plans, while others test it with different drugs or with radiotherapy.[1][4]
Non-small cell lung cancer studies
Several trials study non-small cell lung cancer (NSCLC), which is the most common type of lung cancer.[1][5] One Phase 3 study in early-stage NSCLC compares nivolumab plus platinum doublet chemotherapy against chemotherapy alone in operable stage IB, II, and resectable IIIA disease, and the main outcomes are event-free survival and pathological complete response.[1]
Another Phase 3 study in completely resected stage I or IIA non-squamous NSCLC uses Vinorelbine Tartrate as one of several adjuvant chemotherapy options and measures disease-free survival in patients at high or intermediate risk by a 14-gene prognostic assay.[5] A Phase 2 study in resectable, locally advanced NSCLC (N2) also includes Vinorelbine Tartrate in a neoadjuvant plan and measures event-free survival at 12 months.[6]
Breast cancer studies
One study in metastatic breast cancer is a randomized, double-blinded, placebo-controlled, multicenter Phase II/III trial of oral TherO2-01S22 added to first-line anti-HER2 treatment.[2] Vinorelbine Tartrate appears in the treatment options in this study, and the main outcome is objective response rate, which means the share of patients whose cancer shrinks or disappears.[2]
Another Phase 2 study looks at refractory metastatic breast cancer with liver-dominant disease and compares Melphalan/HDS followed by physician’s choice of eribulin, Vinorelbine Tartrate, or capecitabine against the same drugs alone.[7] The main outcome is hepatic progression-free survival, which is the time before the cancer gets worse in the liver.[7]
Other cancer studies
A Phase 2 study in metastatic colorectal cancer tests Vinorelbine Tartrate and measures objective response rate using RECIST 1.1, with scans every 8 weeks to check response.[3] Patients who do not have an on-study assessment are counted as non-responders in the analysis.[3]
In Hodgkin’s lymphoma, a Phase 1 and Phase IIb study tests atezolizumab with BEGEV, a combination that includes Vinorelbine Tartrate, and the study looks at dose-limiting toxicity in Phase 1 and complete response rate before autologous stem-cell transplantation in Phase IIb.[8]
For children and teenagers, a Phase 1 study combines propranolol with oral metronomic Vinorelbine, and the goal is to find the maximum tolerated dose over the first two treatment cycles.[4] Another pediatric Phase 1/II proof-of-concept study includes VINORELBINE ACCORD in a large set of arms for relapsed or refractory tumors, and it aims to define or validate the recommended phase II dose and then measure early tumor activity.[9]
A Phase 2 study in diffuse intrinsic pontine glioma, a serious brain tumor in children and adolescents, compares conventional and experimental irradiation approaches with concomitant nimotuzumab and Vinorelbine Tartrate, and the main outcome is the number of best responses up to week 36.[10] A Phase 1 trial in rhabdomyosarcoma also includes intravenous and oral Vinorelbine Tartrate in maintenance chemotherapy questions and relapsed disease questions, with outcomes such as recommended phase II dose and event-free survival.[11]
Trial phases and what they mean
Phase 1 studies mainly focus on safety and dose finding.[4][8][9][11] In the Vinorelbine Tartrate trials, this includes finding the maximum tolerated dose or the recommended phase II dose, which helps researchers choose a dose for later studies.[4][8][9]
Phase 2 studies look more closely at whether the treatment seems to work in a specific cancer group.[3][6][7][10] These trials often measure tumor response, survival, or how the disease changes over time.[3][6][7][10]
Phase 3 studies are larger and compare treatment strategies in more patients.[1][5] In the Vinorelbine Tartrate data, these studies focus on survival and response outcomes in lung cancer.[1][5]
Phase 4 is represented by one metastatic breast cancer study, which is a later-stage trial looking at treatment effects in a real-world style research setting.[2]
Main outcomes being measured
The trials use several key outcomes to judge whether treatment is helping.[1][2][3][4][5][6][7][8][9][10][11]
Event-free survival measures how long patients stay free from cancer growth, return, or another important event.[1][6][11]
Disease-free survival measures the time after treatment when no cancer comes back.[5]
Objective response rate shows how many patients have a partial or complete tumor response.[2][3][8]
Pathological complete response checks whether no cancer is found in tissue after treatment.[1]
Hepatic progression-free survival measures how long the cancer stays controlled in the liver.[7]
Maximum tolerated dose and dose-limiting toxicity are used in early studies to find a dose that patients can handle safely.[4][8]
Who may take part
Eligibility depends on the trial and the cancer type being studied.[1][2][3][4][5][6][7][8][9][10][11] Some studies are for adults with early-stage, locally advanced, or metastatic cancer, while others are for children and teenagers with relapsed or refractory disease.[1][2][3][4][7][9]
Several studies also require a specific treatment setting, such as operable disease, resected disease, candidate status for stem-cell transplantation, or a defined risk group.[1][5][8] This means the trial is not open to all patients with the same cancer, but only to those who match the study rules.[1][5][8]
