A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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), Osi alone, or standard of care (SOC) alone. 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 optimized doses of telisotuzumab adizutecan from the dose escalation phase with Osi, or Osi alone. In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 694 adult participants with mCRC 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. During dose optimization participants will receive OSi alone or with 1 of 3 optimized doses of telisotuzumab adizutecan. In stage 2 participnats will recieve 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1.

• Must consent to provide recently obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met immunohistochemistry (IHC) testing and study stratification. c-Met IHC results are required prior to randomization.

• Must have at least one non-irradiated measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.

• Any toxicities from prior systemic anti-cancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level (except for alopecia \[any grade\] or Grade \<= 2 peripheral neuropathy).

• Should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months.

Locations
United States
California
USC Norris Comprehensive Cancer Center /ID# 275343
RECRUITING
Los Angeles
Florida
Mid Florida Hematology And Oncology Center /ID# 275278
RECRUITING
Orange City
Iowa
The Iowa Clinic /ID# 276020
RECRUITING
West Des Moines
Nebraska
Nho - Revive Research Institute /ID# 276115
RECRUITING
Lincoln
Nevada
Renown Regional Medical Center /ID# 276049
RECRUITING
Reno
Other Locations
Australia
Austin Health /ID# 275505
RECRUITING
Heidelberg
St John Of God Murdoch Hospital /ID# 275700
RECRUITING
Murdoch
The Queen Elizabeth Hospital /ID# 275719
RECRUITING
Woodville
Israel
Rambam Health Care Campus /ID# 274542
RECRUITING
Haifa
Rabin Medical Center /ID# 274540
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center /ID# 274541
RECRUITING
Ramat Gan
Japan
Osaka Medical And Pharmaceutical University Hospital /ID# 275684
RECRUITING
Takatsuki
Portugal
Unidade Local de Saude de Braga, EPE /ID# 275394
RECRUITING
Braga
Hospital Cuf Porto /ID# 275395
RECRUITING
Porto
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 275387
RECRUITING
Porto
Republic of Korea
Inje University Haeundae Paik Hospital /ID# 275388
RECRUITING
Busan
Chungbuk National University Hospital /ID# 275768
RECRUITING
Cheongju-si
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 275293
RECRUITING
Kaohsiung City
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Backup
Pawel Wojtach
pawel.wojtach@abbvie.com
4961117201520
Time Frame
Start Date: 2025-08-03
Estimated Completion Date: 2031-12
Participants
Target number of participants: 694
Treatments
Experimental: Stage 1: Escalation Telisotuzumab Adizutecan with Osimertinib
Participants will receive increasing doses of telisotuzumab adizutecan with osimertinib (Osi), as part of the approximately 76 month study duration.
Experimental: Stage 1: Expansion Telisotuzumab Adizutecan Dose A with Osi
Participants will receive telisotuzumab adizutecan dose A with Osi, as part of the approximately 76 month study duration.
Experimental: Stage 1: Expansion Telisotuzumab Adizutecan Dose B with Osi
Participants will receive telisotuzumab adizutecan dose B with Osi, as part of the approximately 76 month study duration.
Experimental: Stage 1: Expansion Telisotuzumab Adizutecan Dose C with Osi
Participants will receive telisotuzumab adizutecan dose C with Osi, as part of the approximately 76 month study duration.
Experimental: Stage 1: Expansion Osi
Participants will receive Osi, as part of the approximately 76 month study duration.
Experimental: Stage 2: Standared of Care (SOC) Osi
Participants will receive Osi, as part of the approximately 76 month study duration.
Experimental: Stage 2: Telisotuzumab Adizutecan Optimized with Osi
Participants will receive the optimized dose of telisotuzumab adizutecan with Osi, as part of the approximately 76 month study duration.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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