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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
NCT06772623 · View on ClinicalTrials.gov ↗
Study Summary
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. Telisotuzumab Adizutecan (ABBV-400) and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of telisotuzumab adizutecan in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 3 treatment groups. Two groups will receive pembrolizumab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive the standard of care (SOC) - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 252 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with IV pembrolizumab, or IV SOC - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months. There may be higher treatment burden for participants in this trial compared to their standard of care.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Telisotuzumab Adizutecan
- DRUG Budigalimab
Study Locations (20)
California
- Providence - St. Jude Medical Center /ID# 271414 — Fullerton
- FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450 — Oxnard
- UCLA - Santa Monica /ID# 271690 — Santa Monica
Colorado
- University Of Colorado - Anschutz Medical Campus /ID# 269069 — Aurora
- Rocky Mountain Cancer Centers - Lone Tree /ID# 272603 — Lone Tree
Ohio
- University Hospitals Cleveland Medical Center /ID# 271726 — Cleveland
- The Mark H Zangmeister Center /ID# 272502 — Columbus
Texas
- Millennium Research & Clinical Development /ID# 271717 — Houston
- Joe Arrington Cancer Research /ID# 272776 — Lubbock
Washington
- Vista Oncology - East Olympia /ID# 275438 — Olympia
- Northwest Medical Specialties Tacoma /ID# 270469 — Tacoma
Florida
- Mid Florida Hematology And Oncology Center /ID# 273777 — Orange City
Illinois
- Hope And Healing Cancer Services /ID# 276223 — Hinsdale
Indiana
- Community Health Network /ID# 273437 — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2025-03-06 |
| Est. Completion | 2027-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06772623
The ClinicalTrials.gov registry entry for NCT06772623 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non Small Cell Lung Carcinoma appearing as the primary indexed condition, and to 4 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06772623 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Colorado, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06772623 about?
NCT06772623 is a clinical study titled "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". 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...
What is the current status of trial NCT06772623?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 252 participants. The study started on 2025-03-06. Estimated completion is 2027-11.
What conditions does trial NCT06772623 study?
This clinical trial studies the following conditions: Non Small Cell Lung Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06772623?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Telisotuzumab Adizutecan (DRUG), Budigalimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06772623?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06772623 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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