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

Recruiting now · Phase 1/Phase 2

Conditions studied: Non Small Cell Lung Carcinoma

In brief

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.

Key facts

Study ID

NCT06772623

Run by

AbbVie

People needed

252

Starts

2025-03-06

Expected to finish

2027-11-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• For Part 2, participant must have evaluable c-Met immunohistochemistry (IHC) result per central testing prior to randomization.
• Must have adequate organ function.

You may not qualify 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 pneumonitis on screening chest computed tomography (CT) scan.

Where it is running

• Northwest Medical Specialties Tacoma /ID# 270469 — Tacoma, Washington, United States (enrolling)
• FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450 — Oxnard, California, United States (enrolling)
• UCLA - Santa Monica /ID# 271690 — Santa Monica, California, United States (enrolling)
• Vista Oncology - East Olympia /ID# 275438 — Olympia, Washington, United States (enrolling)
• Rocky Mountain Cancer Centers - Lone Tree /ID# 272603 — Lone Tree, Colorado, United States (enrolling)
• Mayo Clinic Hospital Jacksonville /ID# 275073 — Jacksonville, Florida, United States (enrolling)
• Mid Florida Hematology And Oncology Center /ID# 273777 — Orange City, Florida, United States (enrolling)
• Hope And Healing Cancer Services /ID# 276223 — Hinsdale, Illinois, United States (enrolling)
• Parkview Comprehensive Cancer Center /ID# 271879 — Fort Wayne, Indiana, United States (enrolling)
• Providence - St. Jude Medical Center /ID# 271414 — Fullerton, California, United States (enrolling)
• Kansas City Cancer Center /ID# 273679 — Overland Park, Kansas, United States (enrolling)
• Dana-Farber Cancer Institute /ID# 278417 — Boston, Massachusetts, United States (enrolling)
• Henry Ford Hospital /ID# 271642 — Detroit, Michigan, United States (enrolling)
• St. Luke'S /ID# 273344 — Duluth, Minnesota, United States (enrolling)
• Mayo Clinic-Rochester /ID# 274512 — Rochester, Minnesota, United States (enrolling)
• Astera Cancer Care /ID# 271915 — East Brunswick, New Jersey, United States (enrolling)
• New York Cancer And Blood Specialists - Shirley /ID# 272547 — Shirley, New York, United States (enrolling)
• University Hospitals Cleveland Medical Center /ID# 271726 — Cleveland, Ohio, United States (enrolling)
• The Mark H Zangmeister Center /ID# 272502 — Columbus, Ohio, United States (enrolling)
• Spoknwrd Clinical Trials /ID# 273776 — Easton, Pennsylvania, United States (enrolling)
• University Of Colorado - Anschutz Medical Campus /ID# 269069 — Aurora, Colorado, United States (enrolling)
• Joe Arrington Cancer Research /ID# 272776 — Lubbock, Texas, United States (enrolling)
• Huntsman Cancer Institute /ID# 271686 — Salt Lake City, Utah, United States (enrolling)
• Virgnia Cancer Specialists /ID# 269633 — Leesburg, Virginia, United States (enrolling)
• Groupe Sante CHC - Clinique du MontLegia /ID# 271760 — Liège, Liege, Belgium (enrolling)

Full record on ClinicalTrials.gov

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