Telisotuzumab Adizutecan for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, telisotuzumab adizutecan, for individuals with non-small cell lung cancer (NSCLC). The primary goal is to evaluate the drug's effects on cancer and its side effects compared to standard treatments. The trial consists of two parts: first, it assesses different doses of the drug, and then it compares the optimal dose to standard care. It suits those with NSCLC who have specific genetic changes (EGFR mutations) and have previously tried one specific treatment. Participants must visit the study site regularly for check-ups and tests. As a Phase 2, Phase 3 trial, this study measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that telisotuzumab adizutecan is generally safe. Earlier studies with patients who have a certain type of lung cancer showed promise, with manageable side effects. This warrants further exploration. The FDA granted fast-track approval to a similar drug for lung cancer, suggesting potential safety for people. While these results are hopeful, joining a clinical trial involves regular check-ups to monitor for any side effects.12345
Why do researchers think this study treatment might be promising?
Most treatments for non-small cell lung cancer, like chemotherapy and immunotherapy, focus on broadly attacking cancer cells or boosting the immune system. But Telisotuzumab Adizutecan works differently by specifically targeting a protein called c-Met, which is often overactive in this type of cancer. This precision targeting could mean more effective attacks on cancer cells while sparing healthy ones, potentially leading to fewer side effects. Researchers are excited because this approach might offer a new option for patients who haven’t responded well to current treatments.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
Research shows that telisotuzumab adizutecan may help treat non-small cell lung cancer (NSCLC). Earlier studies demonstrated that this drug effectively targets and attacks cancer cells, slowing tumor growth. Patients in those studies experienced tumor shrinkage, indicating its potential effectiveness. While exact numbers can vary, evidence suggests that this drug could be a strong option for those fighting NSCLC. This trial will evaluate different doses of telisotuzumab adizutecan to determine the optimal dose for maximum benefit. Ongoing research aims to confirm these findings.
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
Adults with advanced non-squamous NSCLC that has a specific EGFR mutation, who've had one prior treatment and shown disease progression. They must have at least one measurable tumor lesion and be in good physical condition (ECOG 0-1). Those with stable or no symptoms from brain metastasis can join, but not if they have lung conditions like ILD/pneumonitis.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 2 Treatment
Participants receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan
Phase 3 Treatment
Participants receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan or standard of care
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Telisotuzumab Adizutecan
Trial Overview
The trial is testing Telisotuzumab Adizutecan against standard cancer care in two stages. Initially, participants get one of two doses to determine the best dose. In the second stage, they receive this optimal dose or standard care to compare effects on lung cancer activity and safety.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive telisotuzumab adizutecan at the recommended phase 3 dose, as part of the approximately 69 month study duration.
Participants will receive investigator's choice of SOC, as part of the approximately 69 month study duration.
Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 69 month study duration.
Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 69 month study duration.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead 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
Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met ...
Temab-A has a manageable safety profile with promising clinical activity in pts with 3L+ NSQ EGFR MT NSCLC, meriting further investigation.
NCT06772623 | Study to Evaluate Adverse Events and ...
The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a ...
FDA grants accelerated approval to telisotuzumab vedotin ...
FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression.
4.
onclive.com
onclive.com/view/dr-strickler-on-the-safety-and-efficacy-of-telisotuzumab-adizutecan-in-gastric-gej-cancerDr Strickler on the Safety and Efficacy of Telisotuzumab ...
Investigators observed a 28.6% (95% CI, 15.7%-44.6%) objective response rate and a median progression-free survival of 4.0 months (95% CI, 2.76- ...
5.
dailyreporter.esmo.org
dailyreporter.esmo.org/esmo-congress-2024/non-small-cell-lung-cancer/a-c-met-directed-antibody-drug-conjugate-shows-preliminary-activity-in-a-nsclc-cohortA c-Met directed ADC shows preliminary activity in ...
Efficacy and safety of telisotuzumab adizutecan was investigated in patients with EGFR wild type non-squamous disease.
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