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Tests treatment safety and results for Non Small Cell Lung Carcinoma
Official title Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations
ClinicalTrials.gov ID: NCT06772623
What this study is testing
What is Telisotuzumab Adizutecan?
Telisotuzumab Adizutecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non small cell lung carcinoma.
Also referred to as ABBV-400.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. 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 programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally advanced or metastatic will be enrolled...
- Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.
- For Part 1, participants must have had no more than 1 systemic therapy for advanced disease including platinum-based chemotherapy or an immune...
- For Part 2, participants must have no prior systemic therapy for advanced disease, no known actionable genomic alteration.
- Must have documented programmed death ligand 1 (PD-L1) status.
You likely can't join if
- Known uncontrolled metastases to the central nervous system.
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or...
See the full eligibility criteria
- Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally advanced or metastatic will be enrolled into the study.
- Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.
- For Part 1, participants must have had no more than 1 systemic therapy for advanced disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy)...
- For Part 2, participants must have no prior systemic therapy for advanced disease, no known actionable genomic alteration.
- Must have documented programmed death ligand 1 (PD-L1) status.
- For Part 2, participant must have evaluable c-Met immunohistochemistry (IHC) result per central testing prior to randomization.
- Must have adequate organ function.
- Known uncontrolled metastases to the central nervous system.
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Fullerton, California, United States
- Oxnard, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- Lone Tree, Colorado, United States
- Jacksonville, Florida, United States
- Orange City, Florida, United States
- Hinsdale, Illinois, United States
- Fort Wayne, Indiana, United States
- Indianapolis, Indiana, United States
- Overland Park, Kansas, United States
- Boston, Massachusetts, United States
- Duluth, Minnesota, United States
- Rochester, Minnesota, United States
- East Brunswick, New Jersey, United States
- Shirley, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Easton, Pennsylvania, United States
+ 79 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Fullerton, California, United States; Oxnard, California, United States; Santa Monica, California, United States; Aurora, Colorado, United States; Lone Tree, Colorado, United States and 93 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.