Telisotuzumab Vedotin vs. Docetaxel for Non-Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+407 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: AbbVie
Must not be taking: Steroids, Anticonvulsants
Disqualifiers: CNS metastases, Leptomeningeal disease, EGFR mutations, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called telisotuzumab vedotin to see if it can treat a specific type of lung cancer better than an existing drug. The study focuses on adults whose lung cancer has not responded to previous treatments. The new drug targets and kills cancer cells by attaching to a specific protein on their surface.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to understand how your current medications might interact with the trial treatments.
What data supports the effectiveness of the drug docetaxel for non-small cell lung cancer?
What safety information is available for Docetaxel and Telisotuzumab Vedotin in humans?
Docetaxel has been associated with severe side effects, including allergic reactions, low white blood cell counts, fluid retention, breathing difficulties, and nerve damage. There have been reports of heart and breathing problems, including a case of cardiac-respiratory arrest in a patient with pre-existing heart conditions.16789
How does the drug Telisotuzumab Vedotin differ from other drugs for non-small cell lung cancer?
Telisotuzumab Vedotin is unique because it combines an antibody that targets cancer cells with a chemotherapy drug, allowing it to deliver the treatment directly to the cancer cells, potentially reducing side effects compared to traditional chemotherapy like Docetaxel, which affects both cancerous and healthy cells.1481011
Research Team
AI
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
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.Inclusion 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.
See 9 more
Exclusion Criteria
Clinically significant condition(s) as listed in the protocol.
My cancer has a specific change in the EGFR gene.
I have a history of lung scarring or inflammation but not from radiation.
See 6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria
Up to approximately 39 months
Regular visits at a hospital or clinic
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to approximately 19 months
Treatment Details
Interventions
- Docetaxel (Anti-tumor antibiotic)
- Telisotuzumab Vedotin (Monoclonal Antibodies)
Trial OverviewThe 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.
Participant Groups
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.
Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇪🇺 Approved in European Union as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇨🇦 Approved in Canada as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇯🇵 Approved in Japan as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Maimonides Medical Center /ID# 240783Brooklyn, NY
University of California, Los Angeles /ID# 253954Los Angeles, CA
Investigative Clinical Research of Indiana - Indianapolis /ID# 260468Indianapolis, IN
Community Cancer Trials of Utah - South Ogden /ID# 262829Ogden, UT
More Trial Locations
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Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Trials
1079
Patients Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)
References
Development of docetaxel in advanced non-small-cell lung cancer. [2022]Docetaxel, a semisynthetic taxane initially developed for the treatment of breast cancer, has a high degree of activity in lung cancer. Although the mechanisms of action of the taxanes docetaxel and paclitaxel are identical, docetaxel has almost a twofold higher binding affinity for the target site, beta tubulin. In clinical trials, individuals previously treated with paclitaxel benefited from docetaxel. Docetaxel is the standard of care in second-line therapy of advanced non-small-cell lung cancer (NSCLC) and is effective, alone and in combination, in first-line treatment of advanced NSCLC. The standard in first-line therapy of metastatic NSCLC is a platinum doublet with one of the third-generation chemotherapy agents, docetaxel, paclitaxel, gemcitabine, or vinorelbine. Each of these doublets offers similar therapeutic benefit. In a phase-III study comparing docetaxel-cisplatin and docetaxel-carboplatin with vinorelbine-cisplatin, patients treated in the two docetaxel arms had consistently improved global QoL compared to patients treated with the vinorelbine-cisplatin doublet. This landmark study led to Food and Drug Administration (FDA) approval of cisplatin-docetaxel for the treatment of advanced NSCLC. Non-platinum doublets such as docetaxel-gemcitabine have also demonstrated efficacy and safety. Docetaxel has undergone extensive evaluation and is the only agent approved for use in both first- and second-line therapy of advanced NSCLC.
[Efficacy of docetaxel in non-small cell lung cancer patients previously treated with platinum-containing chemotherapy. French Group of Pneumo-Cancerology]. [2018]Determine the response to, and toxicity of docetaxel (Taxotere) in patients (pts) with inoperable non-small-cell lung cancer (NSCLC) previously treated with platinum-containing chemotherapy.
Meta-analysis of docetaxel-based doublet versus docetaxel alone as second-line treatment for advanced non-small-cell lung cancer. [2018]To compare docetaxel-based doublet with single-agent docetaxel as second-line treatment in non-small-cell lung cancer (NSCLC).
Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: an international update. [2019]Based on the results of two recent trials, docetaxel (Taxotere; Aventis, Antony, France) is now the drug of choice for the treatment of advanced non-small cell lung cancer that is refractory to primary chemotherapy. Trials are testing the role of docetaxel in the induction setting, as well as concomitantly with radiation therapy.
Phase I trial of weekly docetaxel and daily temozolomide in patients with metastatic disease. [2021]Docetaxel is second generation taxoid that has shown activity against a variety of cancers and has been approved for use in cancers of the breast, lung, head and neck, ovaries and prostate. Temozolomide is an alkylating agent which crosses the blood brain barrier and has demonstrated antitumor activity against a broad range of tumor types, including malignant glioma, melanoma, non small cell lung cancer and carcinoma of the ovary and colon. A Phase I trial was conducted to determine the toxicity of this combination in refractory solid tumor patients.
Enhancement of docetaxel solubility using binary and ternary solid dispersion systems. [2022]Poor biopharmaceutical properties and toxicities associated with the intravenous formulation of docetaxel (DTX) necessitate the exploration of an alternate oral route of delivery.
Docetaxel-induced cardiac-respiratory arrest in a patient with chronic atrial fibrillation. [2019]Docetaxel has been approved by the Food and Drug Administration for the treatment of many cancer types, including breast cancer, head and neck cancer, lung cancer, and prostate cancer. Many severe to life-threatening side effects (Grades 3-5) of docetaxel have been reported in clinical trials, case reports, and Food and Drug Administration Adverse Events Reporting System. These include anaphylactic reactions, febrile neutropenia, fluid retention, acute respiratory distress, pleural effusion, pneumonia, and peripheral neuropathy. There were fewer cardiac toxicities reported for docetaxel as compared to paclitaxel, which were less severe. In this report, we present a clinical case of docetaxel-induced cardiac-respiratory arrest in a 62-year-old Hispanic male patient with stable chronic atrial fibrillation, who has been recently diagnosed with metastatic prostate cancer. The cardiac event developed within 15 min of docetaxel infusion during the second cycle of chemotherapy despite using recommended premedication with corticosteroids.
Phase III study of docetaxel compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer: results of the West Japan Thoracic Oncology Group Trial (WJTOG 9904). [2022]Docetaxel has shown activity in elderly patients with advanced non-small-cell lung cancer (NSCLC). This randomized phase III trial evaluated the efficacy and safety of docetaxel versus vinorelbine (the current standard treatment) in elderly patients.
Phase III study comparing oral topotecan to intravenous docetaxel in patients with pretreated advanced non-small-cell lung cancer. [2018]This open-label, randomized, multicenter, phase III study compared oral topotecan versus intravenous (IV) docetaxel in patients with previously treated non-small-cell lung cancer (NSCLC).
Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: An international update. [2019]Based on the results of two recent trials, docetaxel (Taxotere; Aventis, Antony, France) is now the drug of choice for the treatment of advanced non-small cell lung cancer that is refractory to primary chemotherapy. Trials are testing the role of docetaxel in the induction setting, as well as concomitantly with radiation therapy.
Summary of phase II data of docetaxel (Taxotere), an active agent in the first- and second-line treatment of advanced non-small cell lung cancer. [2018]Six phase II studies have been conducted in the United States and Europe using docetaxel (Taxotere; Rhone-Poulenc Rorer, Antony, France) for advanced non-small cell lung cancer. One hundred eighty chemotherapy-naive patients in four studies and 88 patients who failed prior platinum-containing chemotherapy in two studies were treated with docetaxel 75 to 100 mg/m2 intravenously over 1 hour every 3 weeks. Fifty-nine percent of patients had adenocarcinoma and 82% had stage IV disease. At a dose of 100 mg/m2, 30% of evaluable chemotherapy-naive patients (27% of the intent-to-treat population) and 20% of evaluable platinum-refractory/resistant patients (17% of the intent-to-treat population) achieved a partial response; projected median survival is 9 months in both studies. Neutropenia was the primary dose-limiting acute side effect. Fluid retention, which occurred in patients who received multiple courses of treatment, was common but rarely dose-limiting, and may be ameliorated with prophylactic corticosteroids. Other toxic effects were relatively mild. Docetaxel has significant activity against advanced non-small cell lung cancer, producing a major response in both chemotherapy-naive patients and patients who had failed prior platinum-containing chemotherapy.