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Purpose

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 of telisotuzumab adizutecan compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 430 adult participants with NSCLC will be enrolled in the study in 200 sites around the world. In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation. - Provide archived or recently obtained tumor tissue during Screening. - Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. - At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated. - Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment. - Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis that required steroids should be excluded. - If the prior third-generation EGFR TKI was administered in the adjuvant setting, progression must have occurred while on treatment.

Exclusion Criteria

  • Tumor(s) have adenosquamous or squamous histology or sarcomatoid features. - Received more than 1 line of systemic therapy in the locally advanced or metastatic setting. - Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 2: Telisotuzumab Adizutecan Dose A 		Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 69 month study duration.
  • Drug: Telisotuzumab Adizutecan
    Intravenous (IV) Infusion
Experimental
Phase 2: Telisotuzumab Adizutecan Dose B 		Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 69 month study duration.
  • Drug: Telisotuzumab Adizutecan
    Intravenous (IV) Infusion
Experimental
Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 Dose 		Participants will receive telisotuzumab adizutecan at the recommended phase 3 dose, as part of the approximately 69 month study duration.
  • Drug: Telisotuzumab Adizutecan
    Intravenous (IV) Infusion
Experimental
Phase 3: Stand of Care (SOC) 		Participants will receive investigator's choice of SOC, as part of the approximately 69 month study duration.
  • Drug: Standard of Care
    Standard of Care

Recruiting Locations

Highlands Oncology Group - Springdale /ID# 277132
Springdale 4132093, Arkansas 4099753 72762
Contact:
Site Coordinator
479-872-8130

Cancer Care Centers of Brevard- Rockledge /ID# 277853
Rockledge 4170358, Florida 4155751 32955

Nho - Revive Research Institute /ID# 277569
Lincoln 5072006, Nebraska 5073708 68506

Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891
Knoxville 4634946, Tennessee 4662168 37909

SCRI Oncology Partners /ID# 276959
Nashville 4644585, Tennessee 4662168 37203

Northwest Cancer Specialists - Vancouver /ID# 277855
Vancouver 5814616, Washington 5815135 98684

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.