A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
Recruiting
Phase 1
Phase 2
Interventional Study
ALK-positive NSCLC
ALK-Positive Lung Cancer
ALK-positive Non-small Cell Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 160 (estimated)
- Sponsor
- TRIANA Biomedicines, Inc. · Industry
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About This Trial
The goal of this clinical trial is to learn about the safety and recommended dose of TRI-611 when administered to adults with ALK-positive non-small cell lung cancer (NSCLC). The trial will also evaluate the antitumor activity of TRI-611 in adults with ALK-positive NSCLC.
The study will be conducted in two parts. The first part will examine different doses of TRI-611. The second part will look at…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Pathologically confirmed diagnosis of ALK-positive non-small cell lung cancer (NSCLC)
* Measurable disease per RECIST v1.1
* Adequate bone marrow reserve and organ function
* Part 1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not…
Contacts