Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07155187 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

StatusRecruiting
PhasePhase 2/3
SponsorAbbVie
Started2025-12-10
View on ClinicalTrials.gov ↗
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib compared to standard of care (SOC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 490 adult participants with NSCLC will be enrolled in the study in 200 sites around the world. In phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan as a monotherapy or in combination with oral osimertinib. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Amendment history 5 changes detected by DataLookout

2026-09-16
minor
Trial sites expanded: 110 → 116 locations
2026-07-10
critical
Primary endpoint(s) modified
WasPhase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR), Phase 3: Progression-Free Survival (PFS) as assessed by BICR
NowPhase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR), Phase 3: Progression-Free Survival (PFS) as assessed by the BICR
2026-07-10
minor
Enrollment increased: 430 → 490 participants
2026-07-10
minor
Trial arms changed: 4 → 6
2026-07-10
minor
Trial sites expanded: 53 → 110 locations
Trial Details
NCT Number NCT07155187
Lead Sponsor AbbVie
Conditions Non-Small Cell Lung Cancer
Enrollment 490 participants
Start Date 2025-12-10
Primary Completion 2030-09 (estimated)
Study Completion 2030-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-15