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NCT06772623 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Non-Small-Cell Lung Carcinoma, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 252
- Enrollment target
- 20
- Study locations
NCT06772623 is a Phase 1 study of Non-Small-Cell Lung Carcinoma that is actively recruiting participants, run by AbbVie. The registered enrollment target is 252 participants, above the 227-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (11% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT06772623, a Phase 1 study of Non-Small-Cell Lung Carcinoma, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 252 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 227-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (11% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
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.
NCT06772623 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Colorado, Ohio.
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.
What interventions are being tested in trial NCT06772623?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Telisotuzumab Adizutecan (DRUG), Budigalimab (DRUG).
Who is sponsoring clinical trial NCT06772623?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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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