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
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
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.
Inclusion Criteria:
Exclusion Criteria:
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Phoenix, Arizona 85054, United States
Fullerton, California 92835, United States
Oxnard, California 93030, United States
Aurora, Colorado 80045, United States
Lone Tree, Colorado 80124, United States
Orange City, Florida 32763, United States
Shirley, New York 11967, United States
Cleveland, Ohio 44106, United States
Beijing, Beijing Municipality 100021, China
Nanchang, Jiangxi 330006, China
Xi'an, Shaanxi 710061, China
Taiyuan, Shanxi 030001, China
Saint-Herblain, Loire-Atlantique 44805, France
Montpellier, Occitanie 34070, France
Nice, Provence-Alpes-Côte d'Azur Region 06189, France
Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany
Meldola, Forlì-Cesena 47014, Italy
Rome, Roma 00144, Italy
Rome, Roma 00184, Italy
Orbassano, Torino 10043, Italy
Niigata, Niigata 951-8520, Japan
Takatsuki, Osaka 569-8686, Japan
Chuo-Ku, Tokyo 104-0045, Japan
Koto-ku, Tokyo 135-8550, Japan
Lublin, Lublin Voivodeship 20-090, Poland
Bialystok, Podlaskie Voivodeship 15-540, Poland
Kielce, Świętokrzyskie Voivodeship 25-734, Poland
Rio Piedras, 00935, Puerto Rico
Cluj-Napoca, Cluj 400015, Romania
Cluj-Napoca, Cluj 400015, Romania
Alicante, 03010, Spain
Chiayi City, 62247, Taiwan
Kaohsiung City, 807, Taiwan
Ankara, Antalya 06010, Turkey (Türkiye)
Adapazarı, Sakarya 54290, Turkey (Türkiye)
Ankara, 06620, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)
Konya, 42080, Turkey (Türkiye)
Leicester, Leicestershire LE1 5WW, United Kingdom
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