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

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
AbbVie
Study ID
NCT07155187
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telisotuzumab Adizutecan — DRUG
    Intravenous (IV) Infusion
  • Standard of Care — DRUG
    Standard of Care
  • Osimertinib — DRUG
    Oral

Study Details

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.

Key Dates

First listed
Sep 4, 2025
Start date
Dec 10, 2025
Status verified
Jul 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
490 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2: Telisotuzumab Adizutecan Dose A
    Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 69 month study duration.
  • Experimental: Phase 2: Telisotuzumab Adizutecan Dose B
    Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 69 month study duration.
  • Experimental: Phase 2: Telisotuzumab Adizutecan Dose A + Osimertinib
    Participants will receive telisotuzumab adizutecan dose A in combination with osimertinib, as part of the approximately 69 month study duration.
  • Experimental: Phase 2: Telisotuzumab Adizutecan Dose B + Osimertinib
    Participants will receive telisotuzumab adizutecan dose B in combination with osimertinib, as part of the approximately 69 month study duration.
  • Experimental: Phase 3: Telisotuzumab Adizutecan Recommended Phase 3 Dose
    Participants will receive telisotuzumab adizutecan at the recommended phase 3 dose, as part of the approximately 69 month study duration.
  • Experimental: Phase 3: Stand of Care (SOC)
    Participants will receive investigator's choice of SOC, as part of the approximately 69 month study duration.

Primary Outcome Measure

Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR) [ Time Frame: Up to Approximately 69 Months ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Highlands Oncology Group - Springdale /ID# 277132SpringdaleArkansas72762
Site Coordinator
479-872-8130
City of Hope National Medical Center /ID# 277005DuarteCalifornia91010-
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928IrvineCalifornia92618-
Cancer Specialists of North Florida /ID# 277332JacksonvilleFlorida32256-
Cancer Care Centers of Brevard- Rockledge /ID# 277853RockledgeFlorida32955-
Moffitt Cancer Center /ID# 276785TampaFlorida33612-
Parkview Research Center /ID# 277651Fort WayneIndiana46845-
HealthPartners Cancer Research Center /ID# 277339Saint Louis ParkMinnesota55426-
Nho - Revive Research Institute /ID# 277569LincolnNebraska68506-
Dartmouth-Hitchcock Medical Center /ID# 277673LebanonNew Hampshire03756-
Astera Cancer Care /ID# 277570East BrunswickNew Jersey08816-4096-
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891KnoxvilleTennessee37909-
SCRI Oncology Partners /ID# 276959NashvilleTennessee37203-
Fred Hutchinson Cancer Center. /ID# 277939SeattleWashington98109-4405-
Northwest Cancer Specialists - Vancouver /ID# 277855VancouverWashington98684-

Find similar trials in Springdale, AR

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Highlands Oncology Group - Springdale· Springdale, ARCity of Hope National Medical Center· Duarte, CACity of Hope - Orange County Lennar Foundation Cancer Center· Irvine, CACancer Specialists of North Florida· Jacksonville, FLCancer Care Centers of Brevard- Rockledge· Rockledge, FLMoffitt Cancer Center· Tampa, FL

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