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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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 pembrolizum

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Telisotuzumab Adizutecan
  • Budigalimab
  • Pembrolizumab
  • Pembrolizumab
  • Carboplatin
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Where

126 sites
Mayo Clinic Hospital - Phoenix /ID# 272971
Phoenix, United States
Providence - St. Jude Medical Center /ID# 271414
Fullerton, United States
FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450
Oxnard, United States
UCLA - Santa Monica /ID# 271690
Santa Monica, United States
University Of Colorado - Anschutz Medical Campus /ID# 269069
Aurora, United States
Rocky Mountain Cancer Centers - Lone Tree /ID# 272603
Lone Tree, United States
Mayo Clinic Hospital Jacksonville /ID# 275073
Jacksonville, United States
Mid Florida Hematology And Oncology Center /ID# 273777
Orange City, United States

โ€ฆand 118 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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