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A Study of Telisotuzumab Adizutecan for EGFR-Mutated Non-Small Cell Lung Cancer

This study is for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR gene mutations (Exon 19 deletion or Exon 21 L858R). It's testing a new drug called telisotuzumab adizutecan, either alone or with osimertinib, against the usual standard of care. Researchers want to see how safe these treatments are and how well they shrink tumors. To join, you'll need to provide a recent tumor tissue sample for testing. The study will look at how many people respond to treatment and how long they live without their cancer getting worse, over about 69 months. The study aims to enroll 490 participants.

Study design
This is an interventional study with two stages. In the first stage (Phase 2), participants will receive one of two doses of telisotuzumab adizutecan, either alone or with osimertinib. In the second stage (Phase 3), participants will receive the best dose identified from Phase 2 or standard of care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 69 months to assess how long they respond to treatment and how long they live without their cancer progressing.

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NCT07155187

A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~490 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Telisotuzumab AdizutecanStandard of CareOsimertinib

At a glance

Recruiting sites
110 of 110 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR)
Measured over Up to Approximately 69 Months
+1 more outcome measured

Conditions

Non-Small Cell Lung Cancer

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Where it's being run

110 sites across 76 states
Taiwan8
Spain6
Turkey (Türkiye)6
Seoul Teugbyeolsi4
Florida3
Central District3
Portugal3
California2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Eligibility criteria

Inclusion

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 recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2). If recently obtained tumor tissue is not available, archived tumor tissue is also acceptable.
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. Participant who has received prior third-generation EGFR TKI therapy in the adjuvant setting must have progressed while on treatment.
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.

Exclusion

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.
Active/symptomatic central nervous system (CNS) metastases. Previously treated brain metastases may be included provided they are radiologically stable.
Evidence of active interstitial lung disease (ILD)/pneumonitis or history of ILD or pneumonitis that required steroids.
Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.

What this trial measures

  • Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR)Up to Approximately 69 Months

    OR is defined as participants achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per the BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  • Phase 3: Progression-Free Survival (PFS) as assessed by the BICRUp to Approximately 69 Months

    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the BICR or death from any cause, whichever occurs earlier.