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
Purpose
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.
Condition
- Non-Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation. - Provide recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2). If recently obtained tumor tissue is not available, archived tumor tissue is also acceptable. - Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry. Participant who has received prior third-generation EGFR TKI therapy in the adjuvant setting must have progressed while on treatment. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. - At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.
Exclusion Criteria
- Tumor(s) have adenosquamous or squamous histology or sarcomatoid features. - Received more than 1 line of systemic therapy in the locally advanced or metastatic setting. - Active/symptomatic central nervous system (CNS) metastases. Previously treated brain metastases may be included provided they are radiologically stable. - Evidence of active interstitial lung disease (ILD)/pneumonitis or history of ILD or pneumonitis that required steroids. - Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Springdale, Arkansas 72762
Site Coordinator
479-872-8130
Duarte, California 91010
Irvine, California 92618
Jacksonville, Florida 32256
Rockledge, Florida 32955
Tampa, Florida 33612
Fort Wayne, Indiana 46845
Saint Louis Park, Minnesota 55426
Lincoln, Nebraska 68506
Lebanon, New Hampshire 03756
East Brunswick, New Jersey 08816-4096
Knoxville, Tennessee 37909
Nashville, Tennessee 37203
Seattle, Washington 98109-4405
Vancouver, Washington 98684
More Details
- Status
- Recruiting
- Sponsor
- AbbVie