Telisotuzumab Vedotin for Lung Cancer

Recruiting at 63 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must not be taking: c-Met antibodies, Docetaxel

Disqualifiers: EGFR mutations, CNS metastases, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an investigational drug called telisotuzumab vedotin for individuals with non-small cell lung cancer (NSCLC). The researchers aim to assess the drug's safety and effectiveness by administering different doses to three groups. Participants will receive the drug through an IV and attend regular check-ups at a hospital or clinic to monitor effects and side effects. Eligible adults have NSCLC with a specific protein (c-Met) and have tried at least one other therapy without success. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 trial coordinators or your doctor to get a clear answer.

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

Research shows that telisotuzumab vedotin is generally safe. In previous studies, researchers administered it to people with non-small cell lung cancer (NSCLC) that had specific protein changes. Most patients tolerated the drug well. Some experienced side effects, but these were usually manageable. Side effects are common with cancer treatments, and the goal is to keep them at levels patients can handle. While telisotuzumab vedotin remains under investigation, current evidence suggests it is relatively well-tolerated by patients with this type of lung cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Telisotuzumab Vedotin is unique because it targets a specific protein called c-Met, which is often overactive in lung cancer cells. Unlike traditional chemotherapy that attacks all rapidly dividing cells, Telisotuzumab Vedotin acts more like a guided missile, delivering its cancer-killing payload directly to the tumor cells. This targeted approach could potentially reduce side effects and improve effectiveness compared to standard treatments like chemotherapy and immunotherapy. Researchers are excited about its precision and the hope that it can provide better outcomes for patients with fewer side effects.

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

Research has shown that telisotuzumab vedotin may effectively treat non-small cell lung cancer (NSCLC), particularly in patients with high levels of the protein c-Met. One study found that about one in three patients experienced tumor shrinkage with this treatment. The effects lasted for a significant period, and most patients managed the side effects well. In this trial, participants will receive varying doses of telisotuzumab vedotin to assess its effectiveness and safety. These results offer promise for those considering this treatment option. ^{3 4 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with non-squamous Non-Small Cell Lung Cancer (NSCLC) that's advanced or spread, who've had no more than one prior chemo treatment and have progressed after therapy. They should be relatively active (able to care for themselves), know their EGFR mutation status, and expect to live at least 12 weeks.

Inclusion Criteria

My doctor expects me to live at least 12 more weeks.

My cancer has been tested for EGFR mutations.

My lung cancer is advanced but not of the squamous type.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous (IV) infusion of telisotuzumab vedotin at 1 of 2 doses as part of a 3 year study duration

3 years

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Telisotuzumab Vedotin

Trial Overview

The trial is testing Telisotuzumab Vedotin, an experimental drug for NSCLC. Participants are randomly assigned to receive one of two doses via IV infusion in a study lasting up to three years across various global locations.

How Is the Trial Designed?

Group I: Telisotuzumab Vedotin Dose C Experimental Treatment 1 Intervention

Participants will receive telisotuzumab vedotin dose C, as part of the 3 year study duration.

Group II: Telisotuzumab Vedotin Dose B Experimental Treatment 1 Intervention

Participants will receive telisotuzumab vedotin dose B, as part of the 3 year study duration.

Group III: Telisotuzumab Vedotin Dose A Experimental Treatment 1 Intervention

Participants will receive telisotuzumab vedotin dose A, as part of the 3 year study duration.

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

Telisotuzumab vedotin is effective in treating MET-overexpressing non-squamous non-small cell lung cancer, but some patients develop resistance to it.

In a case study of a 56-year-old woman with KIF5B-MET fusion-positive lung cancer, capmatinib was able to provide a durable response after she developed resistance to telisotuzumab vedotin, suggesting it as a potential subsequent therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: Salvage capmatinib therapy in KIF5B-MET fusion-positive lung adenocarcinoma with resistance to telisotuzumab vedotin. Lin, CY., Wei, SH., Chen, YL., et al.[2022]

Telisotuzumab vedotin, an antibody-drug conjugate targeting c-Met-overexpressing tumors, showed a manageable safety profile in a phase 1 study with Japanese patients, with no dose-limiting toxicities observed at doses of 2.4 mg/kg and 2.7 mg/kg.

The treatment demonstrated preliminary antitumor activity, with an overall disease control rate of 89% and a median progression-free survival of 7.1 months, confirming the recommended phase 2 dose as 2.7 mg/kg every 3 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 study of telisotuzumab vedotin in Japanese patients with advanced solid tumors. Fujiwara, Y., Kenmotsu, H., Yamamoto, N., et al.[2021]

Telisotuzumab vedotin, an antibody-drug conjugate targeting c-MET, showed a low response rate of only 9% in patients with c-MET-positive squamous cell carcinoma, leading to the early closure of the study due to lack of efficacy.

The treatment was associated with significant toxicities, including three grade 5 adverse events, notably pneumonitis, highlighting safety concerns in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II Study of Telisotuzumab Vedotin in Patients With c-MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753). Waqar, SN., Redman, MW., Arnold, SM., et al.[2022]

Telisotuzumab vedotin (Teliso-V) demonstrated safety and tolerability in patients with non-small cell lung cancer (NSCLC), with no dose-limiting toxicities observed at doses up to 2.2 mg/kg every two weeks and 2.7 mg/kg every three weeks.

In terms of efficacy, 23% of patients with c-Met positive NSCLC showed objective responses to Teliso-V, with a median duration of response of 8.7 months and a median progression-free survival of 5.2 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Study of 2- or 3-Week Dosing of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, Monotherapy in Patients with Advanced Non-Small Cell Lung Carcinoma. Camidge, DR., Morgensztern, D., Heist, RS., et al.[2023]

In a phase 1b study involving 37 patients with advanced non-small cell lung cancer (NSCLC), the combination of Telisotuzumab vedotin (Teliso-V) and nivolumab was found to be well tolerated, with common side effects including fatigue (27%) and peripheral sensory neuropathy (19%).

The combination therapy showed limited antitumor activity, with an objective response rate of only 7.4% and a median progression-free survival of 7.2 months for PD-L1-positive patients, indicating that while the treatment is safe, its effectiveness may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 1b Study of Telisotuzumab Vedotin in Combination With Nivolumab in Patients With NSCLC. Camidge, DR., Barlesi, F., Goldman, JW., et al.[2022]

Citations

1.

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 ...

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8618

LUMINOSITY, a phase 2 study of telisotuzumab vedotin in ...

In the phase 2 LUMINOSITY trial (NCT03539536), Teliso-V monotherapy 1.9 mg/kg showed durable responses and a generally manageable safety profile ...

3.

annalsofoncology.org

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

Results from a phase Ib study of telisotuzumab vedotin in ...

Responses were also comparable between patients who received prior osimertinib treatment that lasted >12 months (47.6%), 6-12 months (66.7%), or ...

4.

onclive.com

onclive.com/view/telisotuzumab-vedotin-maintains-efficacy-across-key-subgroups-in-pretreated-nsclc-with-c-met-overexpression

Telisotuzumab Vedotin Maintains Efficacy Across Key ...

Telisotuzumab vedotin-tllv (Emrelis) was active in patients with c-MET protein–overexpressing non–small cell lung cancer (NSCLC) regardless of prior therapy.

5.

frontiersin.org

frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1673586/full

Evaluating the combined efficacy of Telisotuzumab Vedotin ...

Result: Teliso-V is effective in MET-high non-squamous NSCLC, yielding a response of 34.6% in the LUMINOSITY trial. Moreover, the combination with epidermal ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39805351/

Results from a phase Ib study of telisotuzumab vedotin in ...

Teliso-V plus osimertinib had promising activity and a manageable safety profile in patients with c-Met protein-overexpressing, EGFR-mutated non-squamous NSCLC ...

7.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.103

Primary analysis of the LUMINOSITY trial.

Telisotuzumab vedotin (Teliso-V) monotherapy in patients (pts) with previously treated c-Met–overexpressing (OE) advanced non-small cell lung ...

8.

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 ...