Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07005102 (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, 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

StatusRecruiting
PhasePhase 2/3
SponsorAbbVie
Started2025-08-03
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years 10 months later Dec 2031 → Nov 2036
See other at-risk trials from AbbVie

Amendment history

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
2026-10-01
Notable
Trial sites expanded: 53 → 65 locations
Primary completion pushed: 2031-12 → 2036-11
Eligibility criteria+38 characters
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status [...] od and prior to dosing of study treatment on Cycle 1 Day 1. * Must consent to provide recently obtained formalin-fixed, pa [...] ion. c-Met IHC results are required prior to randomization. * Must have at least one non-irradiated measurable disease per [...] sied within 14 days of the baseline tumor assessment scans. * Any toxicities from prior systemic anti-cancer therapy must [...] ents (CTCAE) Grade 1 or baseline level (except for alopecia \[any grade\] or Grade \<= 2 peripheral neuropathy). * Should not have any major, life-threa [...] [...]
Secondary endpointsdetails revised at 8 of 11 entries
2026-06-04
Minor
Study Status, Contacts/Locations v34
Study sites52→53
2026-06-03
Minor
Study Status, Contacts/Locations v33
Study sites53→52
2026-05-19
Minor
Study Status, Contacts/Locations v32
Trial sites expanded: 48 → 53 locations
2026-05-11
Minor
Study Status, Contacts/Locations v31
Study sites49→48
2026-05-11
Minor
Study Status, Contacts/Locations v30
Study sites47→49
2026-04-13
Minor
Study Status, Contacts/Locations v29
Completion pushed: 2031-12 → 2036-11
Study sites46→47
2026-04-02
Notable
Study Status, Contacts/Locations v28
Trial sites expanded: 43 → 46 locations
Primary completion moved earlier: 2036-11 → 2031-12
Completion moved earlier: 2036-11 → 2031-12
2026-03-19
Minor
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v27
Primary completion date2031-12→2036-11
Completion date2031-12→2036-11
Enrollment target694→854
Study sites41→43
InterventionsOsimertinib (Osi) (Drug), Standard of Care (Drug), Telisotuzumab Adizutecan (Drug)→Carboplatin (Drug), Cisplatin (Drug), Osimertinib (Osi) (Drug), Pemetrexed (Drug), Standard of Care (Drug), Telisotuzumab Adizutecan (Drug)
Eligibility criteria+1,136 characters
[...] 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 m [...] Exclusion Criteria: History of interstitial lung disease (IL [...] ic pneumonitis. Participants has leptomeningeal disease, or subjectparticipant has spinal cord compression not definitively treated with surgery or radiation. History of any malign [...] [...]
Secondary endpoints11 entries, revised
PhaseStage 21: PFS based on BICR assessment per RECIST version 1.1. PhaseStage 21: Duration of response (DoR) based on BICR assessment per RECIST version 1.1. PhaseStage 21: Disease control rate (DC) based on BICR assessment per RECIST version 1.1. PhaseStage 21: Overall Survival PhaseStage 32: Overall Survival PhaseStage 32: OR based on BICR assessment per RECIST version 1.1. PhaseStage 32: DoR based on BICR assessment per RECIST version 1.1. PhaseStage 32: DC based on BICR assessment per RECIST version 1.1. PhaseStage 32: Change from baseline at Week 12 in physical functioning as [...] ncer Quality [...]
Primary endpoints3 entries, revised
PhaseStage 21: Objective Response (OR) Based on Blinded Independent Centr [...] se Evaluation Criteria in Solid Tumors (RECIST) version 1.1 PhaseStage 32: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.
2026-01-21
Minor
Study Status, Contacts/Locations v26
Study sites40→41
2026-01-20
Minor
2 amendments v24-v25
2 re-verifications since 2026-01-15, no change to tracked fields
2025-12-23
Minor
Study Status, Contacts/Locations v23
Study sites39→40
2025-12-22
Minor
2 amendments v21-v22
2 re-verifications since 2025-12-21, no change to tracked fields
2025-12-18
Minor
Study Status, Contacts/Locations v20
Study sites38→39
2025-12-12
Minor
Study Status v19
Re-verified, no change to tracked fields
2025-12-04
Minor
Study Status, Contacts/Locations v18
Study sites37→38
2025-11-27
Minor
Study Status, Contacts/Locations v17
Study sites35→37
2025-11-21
Minor
Study Status, Contacts/Locations v16
Study sites34→35
2025-11-12
Minor
Study Status, Contacts/Locations v15
Study sites33→34
2025-11-08
Minor
Study Status, Contacts/Locations v14
Study sites31→33
2025-11-05
Minor
Study Status, Contacts/Locations v13
Study sites30→31
2025-11-01
Minor
Study Status, Contacts/Locations v12
Study sites29→30
2025-10-31
Minor
Study Status, Contacts/Locations v11
Study sites18→29
2025-09-22
Minor
Study Status, Contacts/Locations v10
Study sites16→18
2025-09-22
Minor
Study Status, Contacts/Locations v9
Study sites11→16
2025-09-18
Minor
Study Status, Contacts/Locations v8
Study sites10→11
2025-09-15
Minor
Study Status, Contacts/Locations v7
Study sites9→10
2025-09-05
Minor
Study Status, Contacts/Locations v6
Study sites8→9
2025-08-29
Minor
Study Status, Contacts/Locations v5
Study sites7→8
2025-08-27
Minor
Study Status, Contacts/Locations v4
Study sites6→7
2025-08-22
Minor
Study Status v3
Re-verified, no change to tracked fields
2025-08-19
Notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09-08→confirmed 2025-08-03
Study sites0→6
2025-05-27
Minor
Original filing
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 "when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum/pemetrexed chemotherapy). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. Osi is a drug approved for the treatment of NSCLC. This study will be divided into two stages, in the first stage participants will receive increasing doses of telisotuzumab adizutecan with Osi. Participants will then be randomized into 4 groups called treatment arms where 3 groups will receive 1 of 3 doses of telisotuzumab adizutecan from from the dose escalation phase with Osi, or standard of care (Osi plus chemotherapy). In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 854 adult participants with 1L estimated glomerular filtration rate (EGFR) mut (mutated) not sufficient quantity (NSq) NSCLC will be enrolled in the study in 200 sites worldwide. In Stage 1, during dose escalation participants will receive increasing intravenous (IV) doses of telisotuzumab adizutecan with oral Osi tablets. participants will receive 1 of 3 doses of telisotuzumab adizutecan with Osi, or standard of care (Osi plus chemotherapy). In stage 2 participants will receive the optimal dose of IV telisotuzumab adizutecanin with oral Osi tablet, or SOC. The study will run for a duration of approximately 76 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.
Trial Details
NCT Number NCT07005102
Lead Sponsor AbbVie
Conditions Non-Squamous Non-Small Cell Lung Cancer, c-MET
Enrollment 854 participants
Start Date 2025-08-03
Primary Completion 2036-11 (estimated)
Study Completion 2036-11 (estimated)
Updated on ClinicalTrials.gov 2026-10-05