~334 spots leftby Mar 2028

Telisotuzumab Vedotin vs. Docetaxel for Non-Small Cell Lung Cancer

Recruiting at 408 trial locations
AC
Overseen ByABBVIE CALL CENTER
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?

Docetaxel is effective in treating advanced non-small cell lung cancer (NSCLC) and is approved for use in both first- and second-line therapy. It has shown improved quality of life in patients compared to other treatments and is a standard option for NSCLC.12345

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 Canada, Japan for the following indications:

🇨🇦
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

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

In a study of 27 patients with inoperable non-small-cell lung cancer (NSCLC) who had previously received platinum-based chemotherapy, docetaxel showed a partial response rate of 24%, indicating its effectiveness as a treatment option.
The main side effect observed was severe neutropenia in 75% of patients, highlighting the need for careful monitoring of blood cell counts during treatment.
[Efficacy of docetaxel in non-small cell lung cancer patients previously treated with platinum-containing chemotherapy. French Group of Pneumo-Cancerology].Robinet, G., Thomas, P., Pérol, M., et al.[2018]
In a meta-analysis of 8 randomized trials involving 2,126 patients with non-small-cell lung cancer, docetaxel-based doublet therapy significantly improved progression-free survival (PFS) and overall response rate (ORR) compared to single-agent docetaxel, but did not show a significant difference in overall survival (OS).
However, the docetaxel-based doublet group experienced higher rates of severe side effects, including grade 3 or 4 neutropenia, thrombocytopenia, and diarrhea, indicating a trade-off between efficacy and safety.
Meta-analysis of docetaxel-based doublet versus docetaxel alone as second-line treatment for advanced non-small-cell lung cancer.Qi, WX., Shen, Z., Yao, Y.[2018]
Docetaxel has been established as the preferred treatment for advanced non-small cell lung cancer that does not respond to initial chemotherapy, based on the results of two recent trials.
Ongoing trials are exploring the use of docetaxel not only as a primary treatment but also in combination with radiation therapy, indicating its potential versatility in cancer treatment.
Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: an international update.Kris, MG., Manegold, C.[2019]

References

Development of docetaxel in advanced non-small-cell lung cancer. [2022]
[Efficacy of docetaxel in non-small cell lung cancer patients previously treated with platinum-containing chemotherapy. French Group of Pneumo-Cancerology]. [2018]
Meta-analysis of docetaxel-based doublet versus docetaxel alone as second-line treatment for advanced non-small-cell lung cancer. [2018]
Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: an international update. [2019]
Phase I trial of weekly docetaxel and daily temozolomide in patients with metastatic disease. [2021]
Enhancement of docetaxel solubility using binary and ternary solid dispersion systems. [2022]
Docetaxel-induced cardiac-respiratory arrest in a patient with chronic atrial fibrillation. [2019]
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]
Phase III study comparing oral topotecan to intravenous docetaxel in patients with pretreated advanced non-small-cell lung cancer. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: An international update. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
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]