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

Recruiting at 511 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if telisotuzumab vedotin, an investigational drug, is more effective than docetaxel, a standard chemotherapy treatment, for non-small cell lung cancer (NSCLC). Researchers are evaluating the efficacy and safety of these drugs in individuals with NSCLC that overproduces a protein called c-Met. Participants will be randomly assigned to receive either telisotuzumab vedotin every two weeks or docetaxel every three weeks. Individuals with NSCLC who have already tried one other treatment but still require additional help might be suitable candidates. Regular check-ups will monitor the effects and side effects of the treatment. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering patients a chance to contribute to the development of a promising new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that telisotuzumab vedotin produced promising results in earlier studies. This drug was tested in people with non-small cell lung cancer (NSCLC) who have specific cancer markers. The studies found that most participants tolerated the drug well, experiencing no severe side effects. The most common, manageable side effects included tiredness and low blood cell counts.

Docetaxel is an approved treatment for various cancers, including NSCLC, with a well-known safety profile. Common side effects include hair loss, low blood cell counts, and nausea, typical of chemotherapy drugs.

Both treatments have undergone thorough study, and while side effects can occur, they are considered safe enough for testing in this new trial. Researchers will closely monitor participants to ensure their safety throughout the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Telisotuzumab Vedotin is unique because it specifically targets cancer cells that express a protein called c-Met, which is often overactive in non-small cell lung cancer. This targeted approach differs from standard treatments like chemotherapy, which attack both healthy and cancerous cells, often leading to broader side effects. Researchers are excited about Telisotuzumab Vedotin because it combines an antibody with a potent cancer-killing agent, aiming to deliver treatment directly to the cancer cells and potentially enhance effectiveness while minimizing damage to healthy tissues.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

In this trial, participants will receive either telisotuzumab vedotin or docetaxel. Research has shown that telisotuzumab vedotin may effectively treat non-small cell lung cancer (NSCLC) in patients with high levels of the protein c-Met. Studies have found that this drug can lead to lasting improvements, especially for patients with a type of NSCLC that does not respond to treatments targeting EGFR. The drug attacks and destroys cancer cells that produce excess c-Met protein, often linked to cancer growth. Previous studies demonstrated strong anti-cancer effects and found it generally well-tolerated by patients. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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]

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 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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03539536

NCT03539536 | Study of Telisotuzumab Vedotin (ABBV- ... This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38843488/

Telisotuzumab Vedotin Monotherapy in Patients With ... Teliso-V was associated with durable responses in c-Met protein-overexpressing nonsquamous EGFR-wildtype NSCLC, especially in those with high c-Met.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.22.00739

Phase Ib Study of Telisotuzumab Vedotin in Combination ... Unfortunately, most patients diagnosed with NSCLC are affected by advanced-stage disease, conferring a 5-year survival rate as low as 7%.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9401525/

Phase I Study of 2- or 3-Week Dosing of Telisotuzumab ... Teliso-V monotherapy was tolerated and showed antitumor activity in c-Met+ NSCLC. On the basis of overall safety, pharmacokinetics, and efficacy outcomes, 1.9 ...

5. annalsofoncology.org annalsofoncology.org/article/S0923-7534%2825%2900005-5/fulltext

Results from a phase Ib study of telisotuzumab vedotin in ... Patients with non-small-cell lung cancer (NSCLC) are often diagnosed with locally advanced or metastatic disease, with a 5-year survival rate of ...

6. news.abbvie.com news.abbvie.com/2023-11-29-AbbVie-Announces-Positive-Topline-Results-from-Phase-2-LUMINOSITY-Trial-Evaluating-Telisotuzumab-Vedotin-Teliso-V-for-Patients-with-Previously-Treated-Non-Small-Cell-Lung-Cancer-NSCLC

AbbVie Announces Positive Topline Results from Phase 2 ... "The results of the Phase 2 LUMINOSITY trial are encouraging for those patients with non-small cell lung cancer with c-Met overexpression as ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2025/761384Orig1s000MultidisciplineR.pdf

761384Orig1s000 - accessdata.fda.gov metastatic EGFR wild-type non-squamous non-small cell lung cancer (NSCLC) with high c-Met ... The data presented in this submission summarize the safety profile ...