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IV telisotuzumab adizutecan versus standard treatment for adults with advanced EGFR‑mutated non‑squamous NSCLC

Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI

Phase2; Phase3 Interventional AbbVie · NCT07155187

This trial tests whether IV telisotuzumab adizutecan works better than standard treatment for adults with advanced non‑squamous non‑small cell lung cancer that has EGFR exon 19 deletion or L858R mutation.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment430 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionstelisotuzumab
Locations53 sites (Springdale, Arkansas and 52 other locations)
Trial IDNCT07155187 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with locally advanced or metastatic non‑squamous NSCLC harboring EGFR exon 19 deletion or exon 21 L858R who progressed after a third‑generation EGFR TKI, have ECOG 0–1, measurable disease, and available tumor tissue are the intended participants.

Not a fit: Patients without the specified EGFR mutations, those with ECOG performance status >1, or those who have not received a prior third‑generation EGFR TKI are unlikely to qualify or derive benefit from this protocol.

Why it matters

Potential benefit: If successful, this treatment could provide a new targeted therapy that shrinks tumors or delays progression in patients with EGFR‑mutated non‑squamous NSCLC.

How similar studies have performed: Antibody‑drug conjugates and other targeted agents have shown activity in lung cancer in earlier trials, but telisotuzumab adizutecan remains investigational and large randomized evidence is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 archived or recently obtained tumor tissue during Screening.
* 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.
* 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.
* Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.
* Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis that required steroids should be excluded.
* If the prior third-generation EGFR TKI was administered in the adjuvant setting, progression must have occurred while on treatment.

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.
* Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.

Where this trial is running

Springdale, Arkansas and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

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-Small Cell Lung CancerTelisotuzumab AdizutecanABBV-400, Standard of CareCancerAndroMETa-Lung-713
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.