IV telisotuzumab adizutecan versus standard treatment for adults with 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 has a phase 2 dose-finding stage followed by a phase 3 randomized comparison of the recommended phase 3 dose (RP3D) of IV telisotuzumab adizutecan versus standard of care. About 430 adults with EGFR exon 19 deletion or L858R‑mutated, locally advanced or metastatic non‑squamous NSCLC who progressed after a third‑generation EGFR TKI will be enrolled across roughly 200 sites worldwide. Phase 2 tests two IV dose levels to identify the RP3D, and phase 3 participants receive either the RP3D or standard care, with monitoring for adverse events and changes in disease activity by RECIST criteria. Tumor tissue must be provided and participants must have measurable disease and ECOG 0–1.

Why it matters

Who can join: the full rules

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 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 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.
* 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.

Where it's running

• Highlands Oncology Group - Springdale /ID# 277132
  Springdale, Arkansas, United States Recruiting
• City of Hope National Medical Center /ID# 277005
  Duarte, California, United States Recruiting
• City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928
  Irvine, California, United States Recruiting
• UC San Diego Health - Moores Cancer Center /ID# 278836
  La Jolla, California, United States Recruiting
• Cancer Specialists of North Florida /ID# 277332
  Jacksonville, Florida, United States Recruiting
• Cancer Care Centers of Brevard- Rockledge /ID# 277853
  Rockledge, Florida, United States Recruiting

+67 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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• BL-B01D1 with Osimertinib before/around surgery for EGFR-mutant resectable NSCLC

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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.