TRI-611 for ALK-positive non-small cell lung cancer (Phase 1/2)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1/2 dose-escalation and expansion trial giving TRI-611 continuously to adults with ALK-positive NSCLC to determine the maximum tolerated or recommended Phase 2 dose and to describe safety. Part 1 uses dose escalation (with backfill cohorts) to identify the MTD/RP2D, and Part 2 enrolls three cohorts defined by prior ALK TKI treatment to measure antitumor activity. Participants take TRI-611 regularly if tolerated, keep a dosing diary, have frequent clinic visits in the first three months, and then clinic visits once every 28-day cycle. Tumor response will be assessed by RECIST v1.1 and safety monitored with labs and clinical exams.

Why it matters

Who can join: the full rules

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 \[in US only: '2 or more ALK TKIs'\], 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

Exclusion Criteria:

* 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
* Ongoing treatment with another anticancer treatment or investigational agent
* Known allergy/hypersensitivity to TRI-611 or any of its ingredients
* Major surgery within 4 weeks of receiving the first dose of TRI-611

Where it's running

• UCSF
  San Francisco, California, United States Recruiting
• University of Colorado Cancer Center
  Aurora, Colorado, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Dana Farber Cancer Center
  Boston, Massachusetts, United States Recruiting
• Washington University Medical Center
  St Louis, Missouri, United States Recruiting
• Memorial Sloan-Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: TRIANA Clinical Trials
• Email: medical@trianabio.com

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NXP900 with Lorlatinib in ALK-positive NSCLC

  This study tests whether adding NXP900 to lorlatinib helps people with ALK-positive non-small cell lung cancer who have already received prior therapy.

  Recruiting Phase 1 Nuvectis Pharma, Inc. · Fairfax, Virginia · NCT07784959

• AQUA07 in ALK-positive NSCLC (phase 1)

  This early-stage trial tests AQUA07 alone and with lorlatinib to see if it is safe and tolerable for adults with ALK-positive non-small cell lung cancer who have tried other ALK inhibitors.

  Recruiting at 7 sites Phase 1 Chugai Pharmaceutical · Houston, Texas and 6 other locations · NCT07617337

• Observational study of lorlatinib for advanced ALK-positive lung cancer patients

  This study looks at how well lorlatinib works and how safe it is for people with advanced ALK-positive lung cancer who are receiving treatment.

  Recruiting Sichuan Cancer Hospital and Research Institute · Chengdu, Sichuan · NCT06361589

• First-line treatment with lorlatinib for advanced ALK+ lung cancer in China

  This study is testing if lorlatinib can be an effective first treatment for people in China with advanced ALK-positive lung cancer.

  Recruiting Phase 2 Guangdong Association of Clinical Trials · Guangzhou, Guangdong · NCT06092086

• Supportive care model for patients with advanced lung cancer

  This study is testing a new supportive care program for people with advanced lung cancer to see if it helps them feel less stressed and more confident about managing their condition compared to standard care.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT04900935

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.