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A Study of Telisotuzumab Adizutecan with Osimertinib for EGFR-Mutated Lung Cancer

This study is for adults with a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that has a specific change called an EGFR mutation. Researchers are looking at how safe Telisotuzumab Adizutecan is when given with Osimertinib (a drug already approved for NSCLC) or with Osimertinib plus standard chemotherapy. Telisotuzumab Adizutecan is an investigational drug. The study will also measure how well these combinations shrink the cancer or stop it from growing. To join, you must be 18 or older, have a good general health status (ECOG performance status of 0 or 1), and provide a recent tumor tissue sample. The study aims to enroll 854 participants.

Study design
This interventional study plans to enroll 854 participants. It will be conducted in two stages, with the first stage involving increasing doses of Telisotuzumab Adizutecan with Osimertinib.
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 76 months to assess objective response, progression-free survival, and adverse events.

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NCT07005102

A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~854 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Standard of CareTelisotuzumab AdizutecanOsimertinib (Osi)CisplatinCarboplatinPemetrexed

At a glance

Recruiting sites
51 of 53 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stage 1: Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured over Up to Approximately 76 Months
+2 more outcomes measured

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

53 sites across 39 states
Spain4
Texas3
Portugal3
Seoul Teugbyeolsi3
Taiwan3
California2
Ontario2
Tokyo2

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

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-fixed, paraffin-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 stratification. 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).
Should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months.
No prior estimated glomerular filtration rate (EGFR) tyrosine kinase inhibitor (TKI) in the locally advanced and/or metastatic setting (except for when it is allowed on study prior to C1D1). Participants treated with prior EGFR TKI in the adjuvant setting are allowed to enroll provided that \>= 126 months (since last dose of e.g., adjuvant osimertinib) have passed before Cycle 1, Day 1.
Diagnosis of histologically or cytologically confirmed metastatic/locally advanced non-squamous NSCLC with documented classical EGFR mutation (Exon 19 Del or Exon 21 L858R) either alone or in combination with other EGFR mutations as detected by an Food and Drug Administration (FDA)-approved or other validated test in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (sites in the US) or an accredited Laboratory (sites outside of the US) in accordance with site standard of care. A copy of the test report documenting the EGFR mutation must be available in the participant records.

Exclusion

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 fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
Participants has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation.
History of any malignancy other than disease under study except for

What this trial measures

  • Stage 1: Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1Up to Approximately 76 Months

    OR is defined as confirmed complete response (CR) or confirmed partial response (PR) per BICR based on RECIST version 1.1.

  • Stage 2: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.Up to Approximately 76 Months

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

  • Number of Participants with Adverse Events (AEs)Up to Approximately 76 Months

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.