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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ironwood Cancer and Research Centers - Chandler /ID# 275443
  Chandler, Arizona, United States Recruiting
• City of Hope National Medical Center /ID# 282241
  Duarte, California, United States Recruiting
• City of Hope - Orange County Lennar Foundation Cancer Center /ID# 284734
  Irvine, California, United States Recruiting
• USC Norris Comprehensive Cancer Center /ID# 275343
  Los Angeles, California, United States Recruiting
• Usc Norris Oncology/Hematology Treatment Center /ID# 278673
  Newport Beach, California, United States Recruiting
• UCLA - Santa Monica /ID# 276816
  Santa Monica, California, United States Recruiting

+15 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.