Authorised Therapeutic confirmatory (Phase III) Non small cell lung cancer (NSCLC)

A Study of Repotrectinib versus Crizotinib in Participants with Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

EU CTIS ID: 2023-505604-32-00

What this study is testing

To compare the Progression Free Survival (PFS) per Blinded Independent Central Review (BICR) of repotrectinib and crizotinib

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC
  • Participant has a ROS1 gene rearrangement/fusion as detected by a local test.
  • At least 1 measurable lesion according to RECIST v1.1, as assessed by the investigator.
  • Participants must not be exposed previously with TKIs that demonstrated activities in ROS1-positive NSCLC
  • Up to 1 prior line of systemic treatment for NSCLC is permitted
  • ECOG Performance Status ≤ 2

You likely can't join if

  • Symptomatic brain metastases or symptomatic leptomeningeal involvement.
  • History of previous cancer requiring therapy within the previous 2 years, except for NSCLC under study, squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected.
  • Known actionable tumor targetable co-mutations or rearrangements
  • Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment)

The study team makes the final eligibility decision.

Where it's taking place

  • Turkey
  • Korea, Democratic People's Republic of
  • Switzerland
  • India
  • Chile
  • Argentina
  • Brazil
  • China
  • United States
  • Canada

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 - 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Turkey; Korea, Democratic People's Republic of; Switzerland; India; Chile; Argentina and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.