NCT06772623 · AbbVie
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
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
DRUG
Budigalimab
IV Infusion
DRUG
Pembrolizumab
IV Injection
DRUG
Pembrolizumab
IV Infusion
DRUG
Carboplatin
IV Infusion
DRUG
Pemetrexed
IV Infusion
DRUG
Cisplatin
IV Infusion
Primary outcome measures
Part 1: Dose-Limiting Toxicities (DLT)s of Telisotuzumab Adizutecan
Time frame: Up to Approximately 84 Days
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Part 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
Time frame: Up to Approximately 33 Months
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) per BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Number of Participants with Adverse Events (AE)s
Time frame: Up to Approximately 33 Months
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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), or appropriate targeted therapy for an actionable gene alteration, if applicable, for epidermal growth factor receptor (EGFR) wild-type (WT) NSq NSCLC.
- 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.
- Must have adequate organ function.
Exclusion criteria
- Known uncontrolled metastases to the central nervous system.
- History of interstitial lung di
Where
- Phoenix, Arizona
- Fullerton, California
- Oxnard, California
- Santa Monica, California
- Aurora, Colorado
- Lone Tree, Colorado
- Jacksonville, Florida
- Orange City, Florida
- Hinsdale, Illinois
- Fort Wayne, Indiana
- Indianapolis, Indiana
- Overland Park, Kansas
And 14 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations