TRI-611, an Oral Drug Tested in Advanced ALK-Positive Lung Cancer
Tests TRI-611 for safety and dosing in adults with ALK-positive non-small cell lung cancer.
Key facts
- Who runs it
- TRIANA Biomedicines, Inc.
- Where
- Milan, Orbassano, Padova, Parma, Ravenna, and Rome, ItalySee the 6 sitesAlso in 6 other countries, 34 sites
- Trial code
- Registry title
- A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 160 people, planned
- Started
- 11 Mar 2026
- Expected to end
- 30 Jan 2034
- Type of study
- Interventional, 4 groups
- Treatments tested
- TRI-611
- Record updated
- 5 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced ALK-positive non-small cell lung cancer that can be measured on scans. What treatment they have had before depends on the part of the trial.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced ALK-positive non-small cell lung cancer (NSCLC), confirmed by pathology, with measurable disease per RECIST v1.1
- Earlier treatment
- Part 1: 2 to 3 earlier ALK TKI medicines, including lorlatinib, but not as the first treatment. Part 2 M1: 2 to 3 ALK TKIs including lorlatinib (not first), but not neladalkib. Part 2 M2: more than 3 ALK TKIs, including lorlatinib and neladalkib, neither as the first treatment. Part 2 M3: no earlier ALK TKI.
- Biomarker or test result
- ALK-positive lung cancer
Main reasons for not taking part
- The cancer has other changes known to cause resistance to ALK TKIs
- Brain or spinal cord spread with worsening nerve symptoms, or needing more and more corticosteroids
- Ongoing treatment with another cancer medicine or investigational drug
- Known allergy to TRI-611 or any of its ingredients
- Major surgery within 4 weeks before the first dose of TRI-611
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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 [in US only: '2 or more ALK TKIs'], prior treatment with lorlatinib is required but must not have been in the first line
- Part 2 Cohort M1: prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line, prior treatment with neladalkib is excluded
- Part 2 Cohort M2: prior treatment with more than 3 ALK TKIs, prior treatment with lorlatinib and neladalkib is required but neither may have been in the first line
- Part 2 Cohort M3: participants without prior ALK TKI treatment
Who cannot take part
- Ongoing treatment with another anticancer treatment or investigational agent
- Major surgery within 4 weeks of receiving the first dose of TRI-611
- Participant's cancer has any additional driver alterations known to be a mechanism of resistance to ALK TKIs
- For participants with central nervous system (CNS) metastases or spinal cord compression, they must not be associated with progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease
- Known allergy/hypersensitivity to TRI-611 or any of its ingredients
Where in Italy
Also in 6 other countries, 34 sites
- Istituto Europeo di Oncologia s.r.lMilan, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyNot yet recruiting
- Istituto Oncologico VenetoPadova, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria ParmaParma, ItalyNot yet recruiting
- Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyNot yet recruiting
- I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyNot yet recruiting
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
The study will be conducted in two parts. The first part will examine different doses of TRI-611. The second part will look at how well TRI-611 works on ALK-positive NSCLC when administered to three groups of participants that differ based on what type of prior therapy they have received.
In this study participants will:
* Take TRI-611 on a continued basis, provided it is well-tolerated, for as long as their disease is not progressing * Visit the clinic approximately seven times in the first 3 months and then just once at the start of each 28-day cycle thereafter * Keep a diary of each time they take the study medication
The 4 groups in the trial
- Part 1: Dose Escalation and BackfillTreatment being tested
Prior treatment with 2 to 3 ALK TKIs, prior treatment with lorlatinib is required but must not have been in the first line
Treatment: TRI-611
- Part 2: Cohort M1Treatment being tested
Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is excluded
Treatment: TRI-611
- Part 2: Cohort M2Treatment being tested
Prior treatment with ALK TKIs, including lorlatinib. Prior treatment with neladalkib is required
Treatment: TRI-611
- Part 2: Cohort M3Treatment being tested
Participants without prior ALK TKI treatment
Treatment: TRI-611
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 1/2, Dose Escalation and Expansion Study of TRI-611, an Oral ALK Molecular Glue Degrader in Participants With Advanced ALK-Positive NSCLC
- Plain-language title
- TRI-611, an Oral Drug Tested in Advanced ALK-Positive Lung CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 5 November 2026