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Anti-tumor antibiotic
Telisotuzumab Vedotin vs. Docetaxel for Non-Small Cell Lung Cancer
Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A histologically documented non-squamous cell NSCLC that is locally advanced or metastatic.
An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 58.25 months
Awards & highlights
Study Summary
This trial is assessing whether telisotuzumab vedotin is more effective than docetaxel and to evaluate the safety of telisotuzumab vedotin in adult patients with NSCLC who have previously been treated.
Who is the study for?
Adults with non-squamous NSCLC who've had one prior chemotherapy can join this trial. They must have c-Met overexpressing cancer, confirmed by a specific test, and be suitable for docetaxel therapy. Those with treated brain metastases stable for 2 weeks may qualify. Exclusions include previous docetaxel use, certain lung conditions, unresolved side effects from past treatments, or other recent cancers.Check my eligibility
What is being tested?
The study compares Telisotuzumab Vedotin (an experimental drug) to Docetaxel in treating NSCLC that's progressed after treatment. Participants are randomly assigned to receive either drug via IV; Teliso-V every 2 weeks or Docetaxel every 3 weeks until they meet criteria to stop the study drug.See study design
What are the potential side effects?
Potential side effects of Telisotuzumab Vedotin could include fatigue, allergic reactions at infusion time, liver issues and blood cell count changes leading to increased infection risk. For Docetaxel: hair loss, nail changes, nausea and muscle pain might occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is advanced or has spread and is not squamous cell type.
Select...
I can carry out all my daily activities without help.
Select...
My lung cancer shows high levels of c-Met protein.
Select...
My cancer has a known EGFR mutation.
Select...
I have had only one chemotherapy treatment for my advanced cancer.
Select...
My NSCLC has worsened despite treatment.
Select...
My cancer has a genetic change that is not in the EGFR gene.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 58.25 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 58.25 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression-Free Survival (PFS) per Independent Central Review (ICR)
Secondary outcome measures
Change from Baseline in Quality of Life as measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-C30.
Duration of Response (DoR), per ICR
Objective Response Rate (ORR), per ICR.
+3 moreSide effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Telisotuzumab VedotinExperimental Treatment1 Intervention
Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
Group II: DocetaxelActive Control1 Intervention
Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
958 Previous Clinical Trials
501,697 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,411 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer is advanced or has spread and is not squamous cell type.I can carry out all my daily activities without help.My lung cancer shows high levels of c-Met protein.My cancer has a specific change in the EGFR gene.My doctor thinks docetaxel therapy is suitable for me.I've had treatment for brain metastases, no growth for 2 weeks, and stable on meds.My cancer has a known EGFR mutation.I have a history of lung scarring or inflammation but not from radiation.I have had cancer before, but it was treated, and I've been cancer-free for at least 2 years.My cancer is identified as adenosquamous.I don't have any ongoing side effects from cancer treatment, except for hair loss or low blood count.I have not had major surgery in the last 3 weeks.I have previously been treated with docetaxel.I have not received treatments targeting c-Met or containing monomethylauristatin E.I have had only one chemotherapy treatment for my advanced cancer.My NSCLC has worsened despite treatment.My cancer worsened within 6 months after finishing chemotherapy.I can provide a recent or past sample of my tumor for c-Met level testing.You have a tumor that can be measured using a specific method called RECIST version 1.1.My cancer has a genetic change that is not in the EGFR gene.
Research Study Groups:
This trial has the following groups:- Group 1: Telisotuzumab Vedotin
- Group 2: Docetaxel
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total patient population for this research?
"A total of 698 patients are needed to participate in this clinical trial. In order to be eligible, patients must meet the specified inclusion criteria. There are various locations where patients can participate in this trial, such as Kaiser Permanente - Northwest /ID# 234123 in Portland, Oregon and St. Joseph Mercy Hospital /ID# 232190 in Ypsilanti, Michigan."
Answered by AI
To how many sites has this trial spread?
"There are 22 sites associated with this trial, three of which are Kaiser Permanente - Northwest /ID# 234123 in Portland, Oregon, St. Joseph Mercy Hospital /ID# 232190 in Ypsilanti, Michigan, and Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228 in Ocala, Florida."
Answered by AI
What are the main purposes that Telisotuzumab Vedotin is used for?
"Telisotuzumab Vedotin is most often prescribed to patients with malignant neoplasms. However, it can also be an effective treatment for sarcoma, esophageal neoplasms, and other conditions."
Answered by AI
Does the research surrounding Telisotuzumab Vedotin date back far?
"There are a total of 339 clinical trials underway for Telisotuzumab Vedotin. Of these, 132 are in the critical third phase. Most of the clinical trials for Telisotuzumab Vedotin are based in Fuzhou, Fujian; however, there are a total of 23424 locations running clinical trials for this treatment."
Answered by AI
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