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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
EU CTIS ID: 2024-518586-10-00
What this study is testing
Phase 2: - To evaluate the safety and tolerability of telisotuzumab adizutecan in combination with osimertinib. - To optimize and select the RP3D of telisotuzumab adizutecan in combination with osimertinib. - To evaluate the efficacy as measured by ORR of telisotuzumab adizutecan in combination with osimertinib. Phase 3: To demonstrate the superiority of telisotuzumab adizutecan in combination with osimertinib over standard of care in terms of efficacy measured by PFS based on BICR assessment.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- All participants must consent to provide recently obtained FFPE tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met IHC testing and study stratification. c-Met IHC results are required prior to randomization.
- Participants must have at least one non-irradiated measurable disease per 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 CTCAE Grade 1 or baseline level (except for alopecia [any grade] or Grade ≤ 2 peripheral neuropathy).
- Participants should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months.
You likely can't join if
- History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest CT scan.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
- History of any malignancy other than disease under study except for a. Malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator. b. Successfully treated nonmelanoma skin cancer. c. Localized carcinoma in situ of the cervix. d. Breast Cancer; lobular carcinoma in situ or ductal carcinoma in situ that is considered completely cured.
- Participants has leptomeningeal disease, or subject has spinal cord compression not definitively treated with surgery or radiation.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Korea, Republic of
- Australia
- Japan
- Singapore
- China
- United States
- Israel
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Korea, Republic of; Australia; Japan; Singapore; China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.