Taletrectinib for Non-Small Cell Lung Cancer

Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)

Recruiting Phase 3 Interventional Study
Non-small Cell Lung Cancer (NSCLC)
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
180 (estimated)
Sponsor
Nuvation Bio Inc. · Industry
Who this trial is looking for

This trial is looking for adults who have early-stage non-small cell lung cancer (NSCLC) that tests positive for certain genetic changes. Participants will receive either taletrectinib or a placebo after surgery to see if it helps prevent the cancer from coming back.

Are You a Good Fit for This Trial?
Rules you out EGFR mutationALK fusion

You may be able to join if

  • I have been diagnosed with stage IB, II, or IIIA NSCLC.
  • I have a documented ROS1 rearrangement in my tumor.
  • I am at least 18 years old.
  • My surgery to remove the lung tumor was done at least 4 weeks ago.
  • I am completely recovered from my surgery.
  • I have a performance status of 0 or 1.
  • I have not received certain cancer treatments for my lung cancer.

You may not be able to join if

  • I have had radiation therapy for my lung cancer.
  • I have taken more than 4 cycles of certain adjuvant therapies.
  • I have had major surgery in the past 4 weeks.
  • I have a history of serious heart problems.
  • I have an active infection.
  • I currently have interstitial lung disease or drug-related lung issues.
  • I have a known history of uncontrolled high blood pressure.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
The purpose of this phase 3 multicenter double-blind randomized study is to assess the use of taletrectinib in the early-stage non-small cell lung cancer (NSCLC). The study compares taletrectinib (study drug) versus placebo (sugar pill) in patients with ROS1-fusion positive stage IB, II, IIIA NSCLC. The study will evaluate if taletrectinib is better than placebo at preventing the participant's dis…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed stage IB, II, or IIIA NSCLC (AJCC 9th edition) based on pathological staging. 2. Documented ROS1 rearrangement in primary tumor by a validated local assay performed in CLIA-certified or locally equivalent diagnostic laboratories. 3. Adequate tissue is…
Contacts

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