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Telisotuzumab adizutecan plus osimertinib for first-line treatment of advanced EGFR-mutated non-squamous NSCLC

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

Phase2; Phase3 Interventional AbbVie · NCT07005102

This test adds the investigational drug telisotuzumab adizutecan to osimertinib (or to osimertinib plus chemotherapy) to see if it helps adults with newly diagnosed advanced EGFR-mutated non-squamous non-small cell lung cancer and to check side effects.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment854 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsosimertinib, radiation, telisotuzumab, chemotherapy
Locations48 sites (Chandler, Arizona and 47 other locations)
Trial IDNCT07005102 on ClinicalTrials.gov

What this trial studies

The trial uses a two-stage design: an initial dose-escalation phase to identify tolerated doses of telisotuzumab adizutecan given with a fixed dose of osimertinib, followed by a randomized phase where participants are assigned to one of four arms (three investigational dose arms plus a standard-of-care arm of osimertinib with platinum/pemetrexed). Key outcomes include monitoring adverse events and measuring change in disease activity by standard imaging criteria. Eligible participants must have EGFR-mutated, locally advanced unresectable or metastatic non-squamous NSCLC, ECOG performance status 0–1, measurable non-irradiated disease, and provide tumor tissue for c-Met IHC stratification prior to randomization. Treatment continues per protocol dosing schedules with regular safety and tumor assessments.

Who should consider this trial

Good fit: Adults with newly diagnosed, locally advanced unresectable or metastatic EGFR-mutated non-squamous NSCLC who are eligible for first-line osimertinib, have ECOG 0–1, measurable non-irradiated disease, and can provide tumor tissue for c-Met testing are ideal candidates.

Not a fit: Patients without EGFR mutations, with squamous cell histology, poor performance status, who cannot provide required tumor tissue, or who cannot tolerate osimertinib/chemotherapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding telisotuzumab adizutecan could improve tumor response rates or delay disease progression when combined with osimertinib.

How similar studies have performed: Early-phase studies of telisotuzumab adizutecan and other MET-targeting antibody–drug conjugates have shown activity in MET-expressing NSCLC, but combining this agent with osimertinib as first-line therapy is a novel approach that remains unproven.

Eligibility criteria

Show full inclusion / exclusion 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-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 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 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

  1. Malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator.
  2. Successfully treated nonmelanoma skin cancer.
  3. Localized carcinoma in situ of the cervix.
  4. Breast Cancer; lobular carcinoma in situ or ductal carcinoma in situ that is considered completely cured.

Where this trial is running

Chandler, Arizona and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Squamous Non-Small Cell Lung CancerTelisotuzumab AdizutecanOsimertinibCisplatinCarboplatinPemetrexedABBV-400Stand of Care
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.