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

Conditions

• Non-Small Cell Lung Cancer

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

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 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. 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 430 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. 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

Start date

Dec 10, 2025

Status verified

Mar 2026

Primary completion

Sep 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

430 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 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 Blinded Independent Central Review (BICR) [ Time Frame: Up to Approximately 69 Months ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (8)

Find similar trials in Springdale, AR

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