Telisotuzumab Vedotin + Osimertinib for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how telisotuzumab vedotin and osimertinib work together to combat non-small cell lung cancer that is worsening and cannot be cured with current treatments. Telisotuzumab vedotin targets and kills cancer cells with specific c-Met receptors, while osimertinib inhibits cancer cell growth. Suitable participants have non-small cell lung cancer that has progressed despite prior osimertinib treatment and possess specific genetic mutations. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it does mention that you must have progressed on osimertinib and continue taking it. Other cancer treatments should not have been taken in the prior 3 weeks or within 5 half-lives of the medication, whichever is shorter.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that combining telisotuzumab vedotin with osimertinib is safe for patients with certain types of lung cancer. Research indicates that this combination has a manageable safety profile, allowing doctors to effectively treat most side effects.
This treatment was tested in patients whose cancer cells have high levels of a protein called c-MET. For these patients, the treatment proved both safe and effective, with most able to continue without severe issues.
Overall, evidence suggests that this treatment can be a safe option for patients with specific lung cancers.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of telisotuzumab vedotin and osimertinib for non-small cell lung cancer because it targets the cancer in a new way. Osimertinib is already known for inhibiting certain mutated proteins that drive cancer growth, but telisotuzumab vedotin adds a unique twist by delivering a potent chemotherapy agent directly to cancer cells expressing a specific protein called c-Met. This dual approach could potentially enhance the effectiveness of treatment by not only blocking signals that tell cancer cells to grow but also directly killing those cells more efficiently, offering hope for better outcomes than current options.
What evidence suggests that telisotuzumab vedotin and osimertinib might be effective for non-small cell lung cancer?
Research has shown that combining telisotuzumab vedotin with osimertinib, the treatment under study in this trial, may help treat certain types of non-small cell lung cancer. Studies found that 50% of patients, whose cancer stopped responding to previous treatments, responded to this combination. This treatment targets and destroys cancer cells with specific proteins, like c-Met and EGFR, on their surfaces. It has been particularly effective in cancers with high levels of c-Met, often leading to significant tumor shrinkage. Overall, these findings suggest this combination could be a strong option for treating hard-to-treat lung cancers.26789
Who Is on the Research Team?
Jonathan W Goldman, MD
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with a specific type of lung cancer (adenocarcinoma) that has worsened despite treatment with osimertinib. Participants must have tumors overexpressing c-Met, be able to swallow pills, and have good organ function and performance status. Those with certain mutations known to resist osimertinib or other histologies like squamous cell are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive telisotuzumab vedotin IV on days 1 and 15 of cycles 1-3 and on day 1 of subsequent cycles, and osimertinib PO daily on days 1-28. Cycles repeat every 28 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with optional tumor biopsy.
What Are the Treatments Tested in This Trial?
Interventions
- Osimertinib
- Telisotuzumab Vedotin
Trial Overview
The trial tests telisotuzumab vedotin combined with osimertinib in treating progressive, incurable non-small cell lung cancer. Telisotuzumab targets tumor cells while delivering a toxic agent to kill them; osimertinib blocks enzymes needed for tumor growth. The study includes CT and MRI scans, biopsies, and biospecimen collection.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive telisotuzumab vedotin IV on days 1 and 15 of cycles 1-3 and on day 1 of subsequent cycles. Patients also receive osimertinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, brain MRI, if needed, and blood sample collection throughout the study. Patients also optionally undergo tumor biopsy during follow-up.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
AbbVie
Industry Sponsor
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
Citations
Results from a phase Ib study of telisotuzumab vedotin in ...
Teliso-V + osimertinib had promising activity in EGFR-mut, c-Met protein-overexpressing NSCLC post-osimertinib progression.
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 ...
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 ...
4.
targetedonc.com
targetedonc.com/view/adding-telisotuzumab-vedotin-to-osimertinib-shows-activity-and-safety-in-tki-resistant-nsclcAdding Telisotuzumab Vedotin to Osimertinib Shows ...
After a median follow-up of 7.4 months, the objective response rate (ORR) was 50.0% (95% CI, 33.4%-66.6%) per independent central review (ICR) ...
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 ...
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 ...
387P Telisotuzumab vedotin (Teliso-V) in combination ...
Conclusions. T + O combination demonstrated tolerable safety and encouraging efficacy with an overall ORR of 50% and DCR of 75% in pts with EGFR-mut ...
NCT02099058 | A Study Evaluating the Safety, ...
This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination ...
Phase Ib Study of Telisotuzumab Vedotin in Combination ...
Teliso-V plus erlotinib showed encouraging antitumor activity and acceptable toxicity in EGFR TKI-pretreated patients with EGFR-M+, c-Met+ NSCLC.
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