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
Public ClinicalTrials.gov record NCT06772623. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Study identification
- NCT ID
- NCT06772623
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 252 participants
Conditions and interventions
Conditions
Interventions
- Telisotuzumab Adizutecan Drug
- Budigalimab Drug
- Pembrolizumab Drug
- Carboplatin Drug
- Pemetrexed Drug
- Cisplatin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 5, 2025
- Primary completion
- Oct 31, 2027
- Completion
- Oct 31, 2027
- Last update posted
- Sep 3, 2026
2025 – 2027
United States locations
- U.S. sites
- 27
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Hospital - Phoenix /ID# 272971 | Phoenix | Arizona | 85054 | Active, not recruiting |
| Providence - St. Jude Medical Center /ID# 271414 | Fullerton | California | 92835 | Recruiting |
| FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450 | Oxnard | California | 93030 | Recruiting |
| UCLA - Santa Monica /ID# 271690 | Santa Monica | California | 90404 | Recruiting |
| University Of Colorado - Anschutz Medical Campus /ID# 269069 | Aurora | Colorado | 80045 | Recruiting |
| Rocky Mountain Cancer Centers - Lone Tree /ID# 272603 | Lone Tree | Colorado | 80124 | Recruiting |
| Mayo Clinic Hospital Jacksonville /ID# 275073 | Jacksonville | Florida | 32224 | Recruiting |
| Mid Florida Hematology And Oncology Center /ID# 273777 | Orange City | Florida | 32763 | Recruiting |
| Hope And Healing Cancer Services /ID# 276223 | Hinsdale | Illinois | 60521 | Recruiting |
| Parkview Comprehensive Cancer Center /ID# 271879 | Fort Wayne | Indiana | 46845 | Recruiting |
| Community Health Network /ID# 273437 | Indianapolis | Indiana | 46202 | Completed |
| Kansas City Cancer Center /ID# 273679 | Overland Park | Kansas | 66210 | Recruiting |
| Dana-Farber Cancer Institute /ID# 278417 | Boston | Massachusetts | 02215 | Recruiting |
| Henry Ford Hospital /ID# 271642 | Detroit | Michigan | 48202 | Recruiting |
| St. Luke'S /ID# 273344 | Duluth | Minnesota | 55805 | Recruiting |
| Mayo Clinic-Rochester /ID# 274512 | Rochester | Minnesota | 55905 | Recruiting |
| Astera Cancer Care /ID# 271915 | East Brunswick | New Jersey | 08816-4096 | Recruiting |
| New York Cancer And Blood Specialists - Shirley /ID# 272547 | Shirley | New York | 11967 | Recruiting |
| University Hospitals Cleveland Medical Center /ID# 271726 | Cleveland | Ohio | 44106 | Completed |
| The Mark H Zangmeister Center /ID# 272502 | Columbus | Ohio | 43219 | Recruiting |
| Spoknwrd Clinical Trials /ID# 273776 | Easton | Pennsylvania | 18045 | Recruiting |
| Millennium Physicians /ID# 271717 | Houston | Texas | 77090 | Completed |
| Joe Arrington Cancer Research /ID# 272776 | Lubbock | Texas | 79410-1121 | Recruiting |
| Huntsman Cancer Institute /ID# 271686 | Salt Lake City | Utah | 84112 | Recruiting |
| Virgnia Cancer Specialists /ID# 269633 | Leesburg | Virginia | 20176 | Recruiting |
| Vista Oncology - East Olympia /ID# 275438 | Olympia | Washington | 98506 | Recruiting |
| Northwest Medical Specialties Tacoma /ID# 270469 | Tacoma | Washington | 98405 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 92 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06772623, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 3, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06772623 live on ClinicalTrials.gov.