Non-Small Cell Lung Cancer study: Telisotuzumab Adizutecan vs Osimertinib
Official title 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
ClinicalTrials.gov ID: NCT07155187
What this study is testing
What is Telisotuzumab Adizutecan?
An investigational intravenous medicine being studied for non‑small cell lung cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how the drug affects disease activity and what side effects it causes compared to usual treatment.
- Who it's for
- Adults with locally advanced or metastatic EGFR‑mutated non‑squamous non‑small cell lung cancer.
- What's involved
- Participants receive the drug by IV infusion, sometimes with the oral drug osimertinib, and attend regular hospital or clinic visits for exams, blood tests, questionnaires and side‑effect monitoring.
- Time commitment
- The study lasts about 69 months, with frequent visits throughout to track treatment effects and safety.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented...
- Provide recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2).
- Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced...
- 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.
You likely can't join if
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Springdale, Arkansas, United States
- Duarte, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Jacksonville, Florida, United States
- Rockledge, Florida, United States
- Tampa, Florida, United States
- Fort Wayne, Indiana, United States
- Saint Louis Park, Minnesota, United States
- Lincoln, Nebraska, United States
- Lebanon, New Hampshire, United States
- East Brunswick, New Jersey, United States
- Knoxville, Tennessee, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
- Vancouver, Washington, United States
- Garran, Australian Capital Territory, Australia
- Kogarah, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Hobart, Tasmania, Australia
+ 83 more site(s).
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, but 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Springdale, Arkansas, United States; Duarte, California, United States; Irvine, California, United States; La Jolla, California, United States; Jacksonville, Florida, United States; Rockledge, Florida, United States and 97 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.