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

NCT07005102Phase 2/3Recruiting

Lead sponsor
AbbVie (Industry)
Enrollment
854 (estimated)
Start date
3 Aug 2025
Primary completion
Nov 2036 (estimated)
Study completion
1 Nov 2036
Last update posted
5 Oct 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential
Masking
Quadruple
Arms
7

Interventions

  • Standard of Care Drug
  • Telisotuzumab Adizutecan Drug
  • Osimertinib (Osi) Drug
  • Cisplatin Drug
  • Carboplatin Drug
  • Pemetrexed Drug

Conditions and primary outcome

  • Non-Squamous Non-Small Cell Lung Cancer
  • c-MET

Primary outcome

Stage 1: Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Up to Approximately 76 Months); Stage 2: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1. (Up to Approximately 76 Months); Number of Participants with Adverse Events (AEs) (Up to Approximately 76 Months)

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT07005102.

CT-VCA trial quality

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Data integrity

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Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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