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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

NCT No.: NCT07005102

Study Type: INTERVENTIONAL

Phase: Phase III

Region: Hawaii

Acronym: 

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

Purpose

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), Osi alone, or standard of care (SOC) alone.

Detailed Description

Sex

Male & Female

Age Limit

Eligibility Criteria

Inclusion Criteria

-Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1.
-Must consent to provide recently obtained formalin- xed, para n-embedded (FFPE) tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met immunohistochemistry (IHC) testing and study strati cation. c--Met IHC results are required prior to randomization
-Must have at least one non-irradiated measurable disease per Response Evaluation Criteria. in Solid Tumors (RECIST) version 1.1. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.
-Any toxicities from prior systemic anti-cancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level (except for alopecia [any grade] or Grade <= 2 peripheral neuropathy).

Exclusion Criteria

-History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan.
-History of idiopathic pulmonary brosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
-Participants has leptomeningeal disease, or subject has spinal cord compression not de nitively treated with surgery or radiation.
-History of any malignancy except for malignancy treated with curative intent and with no known active disease present for 2 years before the rst dose of study treatment and felt to be at low risk for recurrence by investigator, successfully treated nonmelanoma skin cancer
or localized carcinoma in situ of the cervix.

Keywords and/or Specific Medical Conditions

  • Oncology (Adult)

Sponsors

  • AbbVie

Clinical Area

  • Oncology (Adult)

Principal Investigator

Jennifer F Carney , MD 

Contact Information

 - Shelley A Clark, RN
- Moanalua Medical Center and Clinic

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