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 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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 5 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 20, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- AbbVie
- Interventions being studied
- Drug: Telisotuzumab Adizutecan; Drug: Budigalimab; Drug: Pembrolizumab; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Cisplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic Hospital - Phoenix /ID# 272971Phoenix, Arizona
- Providence - St. Jude Medical Center /ID# 271414Fullerton, California
- FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450Oxnard, California
- UCLA - Santa Monica /ID# 271690Santa Monica, California
- University Of Colorado - Anschutz Medical Campus /ID# 269069Aurora, Colorado
- Rocky Mountain Cancer Centers - Lone Tree /ID# 272603Lone Tree, Colorado
- Mayo Clinic Hospital Jacksonville /ID# 275073Jacksonville, Florida
- Mid Florida Hematology And Oncology Center /ID# 273777Orange City, Florida
- Hope And Healing Cancer Services /ID# 276223Hinsdale, Illinois
- Parkview Comprehensive Cancer Center /ID# 271879Fort Wayne, Indiana
- Community Health Network /ID# 273437Indianapolis, Indiana
- Kansas City Cancer Center /ID# 273679Overland Park, Kansas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 20, 2026. Always confirm current availability with the study team.