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

Recruiting at 412 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must not be taking: Steroids, Anticonvulsants

Disqualifiers: CNS metastases, Leptomeningeal disease, EGFR mutations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 39 months

698 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 4 8 10 11}

Research Team

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.

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.

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
• Telisotuzumab Vedotin

Trial Overview 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.

Participant Groups

Group I: Telisotuzumab Vedotin Experimental Treatment 1 Intervention

Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.

Group II: Docetaxel Active Control 1 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

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

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

Docetaxel is a highly effective treatment for advanced non-small-cell lung cancer (NSCLC), showing improved patient quality of life compared to vinorelbine-cisplatin in clinical trials, leading to its FDA approval for this indication.

With a higher binding affinity for beta tubulin than paclitaxel, docetaxel is the only chemotherapy agent approved for both first- and second-line therapy of advanced NSCLC, demonstrating its versatility and efficacy in various treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of docetaxel in advanced non-small-cell lung cancer. Belani, CP., Eckardt, J.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: an international update. Kris, MG., Manegold, C.[2019]

In a Phase I trial involving 25 patients with metastatic cancers, the combination of docetaxel and temozolomide was found to be well tolerated, with mild to moderate side effects like nausea and fatigue, and manageable hematological toxicity.

Although the maximum tolerated dose was not established, the study suggests a recommended dosing regimen for future Phase II trials, indicating that this combination therapy can be safely administered to patients with refractory solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of weekly docetaxel and daily temozolomide in patients with metastatic disease. Tamaskar, I., Mekhail, T., Dreicer, R., et al.[2021]

The study successfully enhanced the solubility of the poorly soluble drug docetaxel (DTX) using a solid dispersion technique, with Soluplus showing the best results, achieving a 93-fold increase in solubility compared to crystalline DTX.

The optimal binary solid dispersion of DTX and Soluplus (1:10) demonstrated significant improvements in solubility, making it a promising candidate for developing an effective oral formulation of DTX.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancement of docetaxel solubility using binary and ternary solid dispersion systems. Lim, SM., Pang, ZW., Tan, HY., et al.[2022]

Docetaxel, an FDA-approved chemotherapy for various cancers, can cause severe side effects, including life-threatening reactions such as anaphylaxis and cardiac-respiratory arrest, as demonstrated in a case involving a 62-year-old patient with metastatic prostate cancer.

Despite premedication with corticosteroids, the patient experienced a cardiac-respiratory arrest within 15 minutes of receiving docetaxel, highlighting the need for careful monitoring during treatment, especially in patients with pre-existing conditions like atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel-induced cardiac-respiratory arrest in a patient with chronic atrial fibrillation. Huq, M., Balvanz, TM., Mambourg, S.[2019]

In a study of 182 elderly patients (average age 76) with advanced non-small-cell lung cancer, docetaxel showed a significant improvement in progression-free survival (5.5 months) and response rates (22.7%) compared to vinorelbine (3.1 months and 9.9%, respectively).

While docetaxel did not significantly improve overall survival compared to vinorelbine, it was associated with better disease-related symptom improvement and was generally well tolerated, making it a potential option for standard treatment in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Kudoh, S., Takeda, K., Nakagawa, K., et al.[2022]

In a study of 829 patients with previously treated non-small-cell lung cancer, oral topotecan demonstrated noninferiority to intravenous docetaxel in terms of 1-year survival rates, with 25.1% for topotecan compared to 28.7% for docetaxel.

Both treatments had different safety profiles; docetaxel was associated with higher rates of severe neutropenia (60% vs. 50%), while topotecan led to more cases of severe anemia and thrombocytopenia (26% vs. 10% and 26% vs. 7%, respectively).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase III study comparing oral topotecan to intravenous docetaxel in patients with pretreated advanced non-small-cell lung cancer. Ramlau, R., Gervais, R., Krzakowski, M., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: An international update. Kris, MG., Manegold, C.[2019]

Docetaxel shows significant efficacy in treating advanced non-small cell lung cancer, with a 30% partial response rate in chemotherapy-naive patients and 20% in those who had previously failed platinum-based treatments, based on six phase II studies involving 268 patients.

The primary side effect of docetaxel is neutropenia, while fluid retention is common but usually manageable with corticosteroids, indicating that the treatment has a manageable safety profile.

NCBI (Pubmed)

pubmed.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. Fossella, FV., Lee, JS., Berille, J., et al.[2018]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Development of docetaxel in advanced non-small-cell lung cancer. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Efficacy of docetaxel in non-small cell lung cancer patients previously treated with platinum-containing chemotherapy. French Group of Pneumo-Cancerology]. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Meta-analysis of docetaxel-based doublet versus docetaxel alone as second-line treatment for advanced non-small-cell lung cancer. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: an international update. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Phase I trial of weekly docetaxel and daily temozolomide in patients with metastatic disease. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Enhancement of docetaxel solubility using binary and ternary solid dispersion systems. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Docetaxel-induced cardiac-respiratory arrest in a patient with chronic atrial fibrillation. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

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]

9. United States pubmed.ncbi.nlm.nih.gov

Phase III study comparing oral topotecan to intravenous docetaxel in patients with pretreated advanced non-small-cell lung cancer. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: An international update. [2019]

11. United States pubmed.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]