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Non-Squamous Non-Small Cell Lung CancerCancerDrugPhase 2, Phase 3

What this study is

Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity "when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum/pemetrexed chemotherapy).

Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. Osi is a drug approved for the treatment of NSCLC. This study will be divided into two stages, in the first stage participants will receive increasing doses of telisotuzumab adizutecan with Osi. Participants will then be randomized into 4 groups called treatment arms where 3 groups will receive 1 of 3 doses of telisotuzumab adizutecan from from the dose escalation phase with Osi, or standard of care (Osi plus chemotherapy). In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 854 adult participants with 1L estimated glomerular filtration rate (EGFR) mut (mutated) not sufficient quantity (NSq) NSCLC will be enrolled in the study in 200 sites worldwide.

In Stage 1, during dose escalation participants will receive increasing intravenous (IV) doses of telisotuzumab adizutecan with oral Osi tablets. participants will receive 1 of 3 doses of telisotuzumab adizutecan with Osi, or standard of care (Osi plus chemotherapy). In stage 2 participants will receive the optimal dose of IV telisotuzumab adizutecanin with oral Osi tablet, or SOC. The study will run for a duration of approximately 76 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.

What's being tested

  • Standard of Care

    Intervention · DRUG

    Standard of Care

  • Telisotuzumab Adizutecan

    Intervention · DRUG

    Intravenous (IV)

  • Osimertinib (Osi)

    Intervention · DRUG

    Oral

  • Cisplatin

    Intervention · DRUG

  • Carboplatin

    Intervention · DRUG

  • Pemetrexed

    Intervention · DRUG

All of Cisplatin, Carboplatin, Pemetrexed

IV

Study details

Official title
A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
Sponsor
AbbVie
Conditions
Non-Squamous Non-Small Cell Lung Cancer · c-MET
Enrolling
854 people
Starts
2025-08-03
Est. completion
2036-11
Design
Quadruple-blind, randomized, sequential groups, Phase 2, Phase 3
Record
View on ClinicalTrials.gov ↗