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Monoclonal Antibodies

Telisotuzumab Vedotin for Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have locally advanced or metastatic non-small cell lung cancer (NSCLC)

Must have received no more than 2 lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting. Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same tyrosine kinase (TK) count as 1 line of therapy for the purposes of this eligibility criterion.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

Study Summary

This trial is designed to find what population of Non-Small Cell Lung Cancer patients will respond best to the telisotuzumab vedotin therapy, and then to expand that group to further evaluate efficacy.

Who is the study for?

This trial is for adults with non-squamous Non-Small Cell Lung Cancer (NSCLC) that does not have a certain mutation called EGFR. Participants must have c-Met+ NSCLC, confirmed by specific lab tests, and should have tried no more than two previous systemic therapies. They need to be in good physical condition (ECOG 0-1), and cannot join if they've had other cancers recently, untreated hepatitis B or C, HIV infection, lung diseases like ILD/pneumonitis, or major surgery within the last three weeks.Check my eligibility

What is being tested?

The study is testing Telisotuzumab vedotin on patients who overexpress c-Met and are in their second or third line of cancer treatment. It's done in stages: first to find which NSCLC populations benefit most from the drug (Stage 1 completed), then expanding this group to further test effectiveness (Stage 2), followed by an additional cohort at a different dose level for safety and efficacy evaluation (Stage 3).See study design

What are the potential side effects?

While specific side effects of Telisotuzumab vedotin aren't listed here, similar drugs often cause fatigue, nausea, hair loss (alopecia), blood disorders like anemia or clotting issues; nerve damage leading to numbness or tingling; allergic reactions during infusion; liver problems; and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is advanced or metastatic non-small cell lung cancer.

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I've had 2 or fewer treatments for my advanced cancer, including only 1 chemotherapy.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Events (Alternate dose cohort)

Overall Response Rate (ORR) (Stage 1 and Stage 2)

Secondary outcome measures

Disease Control Rate (DCR) (Stage 1 and Stage 2)

Duration of Response (DoR) (Stage 1 and Stage 2)

Overall Survival (OS) (Stage 1 and Stage 2)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Telisotuzumab vedotinExperimental Treatment1 Intervention

Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

500,835 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,669 Total Patients Enrolled

Media Library

Telisotuzumab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03539536 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Telisotuzumab vedotin

Non-Small Cell Lung Cancer Clinical Trial 2023: Telisotuzumab Vedotin Highlights & Side Effects. Trial Name: NCT03539536 — Phase 2

Telisotuzumab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03539536 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the number of hospitals participating in this experiment?

"This clinical trial is enrolling participants at Icri, Highlands Oncology Group, The Ottawa Hospital and 55 other medical centres. Specifically, the Icri site has an ID of 227835 in Whittier, California; the Highlands Oncology Group's location has an ID number of 215600 located in Springdale Arkansas; and finally, The Ottawa Hospital's enrolment hub holds a unique identifier of 205579 situated in Ontario."

Answered by AI

Is this experiment the inaugural endeavor of its type?

"Telisotuzumab vedotin has been investigated since its inception in 2014, sponsored by AbbVie. Following successful Phase 1 trials involving 260 participants, 3 more studies have commenced across 284 locations and 38 nations."

Answered by AI

What can be said about the potential hazards of Telisotuzumab vedotin?

"The safety of Telisotuzumab vedotin was rated a 2, as evidence from the Phase 2 trial suggests that there is some level of safety but no data regarding efficacy."

Answered by AI

How many individuals have enrolled in this investigation thus far?

"In order to conduct the study, AbbVie is seeking 270 participants that meet all inclusion criteria. The medical trial will be administered from Icri /Id# 227835 in Whittier, California and Highlands Oncology Group /ID# 215600 in Springdale, Arkansas."

Answered by AI

What further research has been undertaken regarding Telisotuzumab vedotin?

"Presently, 3 clinical trials are actively studying Telisotuzumab vedotin's effects with one study in its third phase. Matsusaka-shi, Mie is the primary site of research; however, there are 587 other locations across the world conducting studies on this medication."

Answered by AI

What is the main aim of this trial?

"This clinical trial, monitored for up to 3 years, aims to assess Overall Response Rate (ORR) and Disease Control Rate (DCR). Secondary measures include Duration of Response (DoR), which is the time from initial response until radiographic progression or death from any cause. Additionally, DCR will be calculated as a percentage of participants with best overall response out of confirmed CR, PR or stable disease lasting 12 weeks following enrolment according to RECIST v1.1 standards."

Answered by AI

Is this medical experiment currently accepting participants?

"Affirmative. According to the information published on clinicaltrials.gov, this experiment begun recruiting participants on October 10th 2018 and its latest update was November 24th 2022. The study is in need of 270 patients across 55 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

2018. "Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03539536.

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