Study on the Safety, Effectiveness, and Best Dose of IV Telisotuzumab Adizutecan with IV Budigalimab for Advanced Non-Squamous NSCLC
Sponsor: AbbVie
ClinicalTrials ID:NCT06772623
This clinical trial is testing a new combination of drugs, Telisotuzumab Adizutecan and Budigalimab, to see if they are safe and effective in treating adults with advanced non-squamous non-small cell lung cancer (NSCLC) who have not received prior treatment for advanced disease.
Patient Parameters
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Program Overview
The study aims to find out if a new combination of drugs, Telisotuzumab Adizutecan and Budigalimab, can safely and effectively treat advanced non-squamous non-small cell lung cancer (NSCLC) in adults. The trial will be conducted in two stages. In the first stage, different doses of the drugs will be tested to find the best dose that is both safe and effective. In the second stage, participants will be divided into four groups to receive different treatments, including the new drug combination and standard treatments, to compare their effects. The study will involve about 172 participants across 132 sites worldwide and will last approximately 33 months.
Description
This study is testing a new treatment for advanced non-squamous non-small cell lung cancer (NSCLC) using two investigational drugs, Telisotuzumab Adizutecan and Budigalimab. The trial is divided into two stages. In the first stage, participants will receive increasing doses of Telisotuzumab Adizutecan with Budigalimab to find the best dose that is safe and effective. In the second stage, participants will be split into four groups. Two groups will receive Budigalimab with different doses of Telisotuzumab Adizutecan. Another group will receive Budigalimab with standard chemotherapy drugs, and the last group will receive standard care with Pembrolizumab and chemotherapy. The study will last about 33 months, and participants will have regular visits to a hospital or clinic for check-ups, blood tests, and to monitor side effects. This trial may require more frequent visits and tests compared to standard treatments.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
- Have measurable cancer based on specific medical criteria.
- For Part 1: Have had no more than one previous treatment for advanced disease, which could include chemotherapy or targeted therapy if applicable.
- For Part 2: Have not received any prior treatment for advanced disease and have no known genetic changes that can be targeted with specific drugs.
- Have documented PD-L1 status.
- Have good organ function as determined by medical tests.
Exclusion Criteria
- Have uncontrolled cancer spread to the brain or central nervous system.
- Have a history of lung diseases like interstitial lung disease or pneumonitis that required treatment with steroids, or show signs of these conditions on a CT scan.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence - St. Jude Medical Center /ID# 271414 | 92835 | Fullerton | California |
| FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450 | 93030 | Oxnard | California |
| Rocky Mountain Cancer Centers - Lone Tree /ID# 272603 | 80124 | Lone Tree | Colorado |
| Mid Florida Hematology And Oncology Center /ID# 273777 | 32763 | Orange City | Florida |
| Astera Cancer Care /ID# 271915 | 08816-4096 | East Brunswick | New Jersey |
| New York Cancer and Blood Specialists - New York /ID# 272547 | 10028 | New York | New York |
| The Mark H Zangmeister Center /ID# 272502 | 43219 | Columbus | Ohio |
| Millennium Research & Clinical Development /ID# 271717 | 77090 | Houston | Texas |
| Northwest Medical Specialties Tacoma /ID# 270469 | 98405 | Tacoma | Washington |
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