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Phase 3 Study of Taletrectinib as Adjuvant Therapy in Patients with Completely Resected ROS1‑Positive Stage IB‑IIIA Non‑Small Cell Lung Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study looks at patients with completely removed Non Small Cell Lung Cancer that has a specific genetic change called ROS1-fusion positive. After surgery, participants will receive either the oral medicine taletrectinib taken as a capsule once daily, or a matching placebo capsule that looks the same but contains no active drug.

The main aim is to see whether the medicine can keep the cancer from coming back compared with the placebo, measured by the length of time patients stay free of disease, known as DFS. Participants will take the study medication for a set period, return for regular check‑ups, and have routine tests such as scans and lab work to monitor their health.

In addition to tracking if the cancer returns, the study will also look at overall survival, which is how long participants live after treatment, referred to as OS, and whether the disease spreads to the CNS. Safety will be watched by recording any side effects using a standard grading system (CTCAE) and by performing simple heart rhythm checks (ECG). The study follows participants for several years to gather this information.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and baseline assessments

    After joining the study, the participant is assigned to receive either taletrectinib capsules or matching placebo capsules in a double‑blind manner, meaning the participant and the study team do not know which treatment is given.

    Baseline measurements are collected, including physical examination, vital signs, laboratory tests, electrocardiogram (ECG), and imaging to confirm that no cancer is detectable after surgery.

  2. Step 2

    Initiation of study medication

    The participant begins taking the assigned study medication.

    Each dose consists of one oral capsule containing 400 mg of taletrectinib (or a matching placebo capsule).

    The medication is taken by mouth according to the schedule defined by the study protocol.

  3. Step 3

    Regular safety monitoring visits

    Periodic clinic visits are scheduled to evaluate safety and tolerability.

    During each visit, the participant undergoes a physical examination, vital‑sign measurement, laboratory testing, and an ECG to detect any adverse events.

  4. Step 4

    Assessment of disease‑free survival

    The investigator evaluates whether cancer has returned, a measure known as disease‑free survival.

    Assessments are performed at predefined intervals throughout the study, including at 2, 3, 4, and 5 years after starting the medication.

  5. Step 5

    Long‑term follow‑up

    The participant continues to be followed for up to five years to collect information on overall survival, central nervous system disease‑free survival, and any late‑occurring side effects.

    Blood samples may be taken to measure plasma concentrations of taletrectinib.

  6. Step 6

    Study completion or early discontinuation

    The study ends for the participant when the predefined follow‑up period is completed, when disease recurrence is confirmed, or if the participant chooses to stop the medication.

    Final assessments are performed to document the participant’s status at the end of the trial.

Who can join the trial?

8 criteria

  • You have a confirmed diagnosis of non‑small cell lung cancer (NSCLC) that has been examined under a microscope, and the cancer is classified as stage IB, II, or IIIA according to the standard staging system.
  • Your tumor shows a specific genetic change called a ROS1 rearrangement, identified by a test performed in a laboratory that meets certified quality standards (CLIA‑certified or equivalent).
  • There is enough tumor tissue available so it can be tested again in a central laboratory to confirm the ROS1 result (if the same certified test was already done, extra confirmation is not needed, but tissue must still be sent for other studies).
  • You are 18 years of age or older.
  • Your overall health and ability to perform daily activities is rated as 0 or 1 on the ECOG performance status scale, meaning you are fully active or have only minor restrictions.
  • You have undergone surgery intended to cure the cancer, and the surgeon removed all visible tumor with negative margins (no cancer cells at the edge of the removed tissue).
  • You have fully recovered from the surgery:
    • If you did not receive additional chemotherapy, the surgery must have been performed at least 4 weeks and no more than 16 weeks before you could join the study.
    • If you did receive post‑surgery (adjuvant) chemotherapy, the surgery must have been performed at least 4 weeks and no more than 30 weeks before enrollment, the last chemotherapy dose must have been given at least 7 days earlier, and any side effects must have resolved to mild or none (grade 1 or lower according to CTCAE v5.0).

Who cannot join the trial?

14 criteria

  • Previous cancer treatments that are not allowed: having had radiation therapy after surgery for the current lung cancer, or any additional cancer drugs (except the standard platinum‑based chemotherapy) before the study starts.
  • Too many cycles of standard chemotherapy: having received more than four cycles of the usual platinum‑based chemotherapy regimen.
  • Immune checkpoint inhibitor (ICI) limits: if you received an ICI, you must have had no more than four cycles, and at least 12 weeks must have passed since the last dose, with any side effects from the ICI fully resolved.
  • Recent major surgery: having any major operation (including removal of the lung tumor) within four weeks before the study begins.
  • Limited lung surgery: having only a segmentectomy or wedge resection (partial removal of the tumor) unless you meet very specific stage criteria.
  • Use of strong CYP3A drugs or foods: taking medicines or eating substances that strongly affect the liver enzyme CYP3A within 14 days before randomization.
  • Recent investigational therapy: having taken any experimental drug for any condition (not just lung cancer) within the past six months.
  • Co‑mutations of EGFR or ALK: having genetic changes in the EGFR (epidermal growth factor receptor) or ALK (anaplastic lymphoma kinase) genes in addition to the ROS1 fusion.
  • History of other cancers: having had another cancer, except for non‑melanoma skin cancer, in‑situ cancer, or cancers that were cured and have been disease‑free for more than three years.
  • Significant heart disease: having serious cardiovascular problems (such as heart failure or recent heart attack) within three months before the study.
  • Uncontrolled high blood pressure: having blood pressure that is not well controlled by medication.
  • Serious heart rhythm problems: ongoing heart rhythm disturbances (grade 2 or higher), uncontrolled atrial fibrillation, a QT interval (a measure of heart electrical activity) longer than 470 ms, very slow heart rate (<45 beats per minute), or taking medicines that can cause a dangerous rhythm called Torsades de Pointes (TdP). Also, low levels of potassium, magnesium, or calcium must be corrected before randomization.
  • Active serious infections: having a current bacterial, fungal, or viral infection that is clinically important, including hepatitis B, hepatitis C, or HIV infection.
  • Interstitial lung disease or pneumonitis: having current or past interstitial lung disease, drug‑related lung inflammation, or radiation‑induced lung inflammation that required treatment with steroids.
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Investigated drugs

Taletrectinib is an oral medication taken in capsule form. In this study, it is being tested to see if it can help prevent the cancer from coming back after patients have had surgery to remove a ROS1‑fusion positive non‑small cell lung tumor. The drug is given to participants after their tumor has been completely removed, and researchers will compare how well it works to keep the disease from returning compared with a placebo.

What is already known about the treatment

  • Taletrectinib

    Taletrectinib is taken as a 400 mg oral capsule taken by mouth. It is still an experimental drug that is being studied in phase 3 clinical trials for patients with ROS1‑positive non‑small cell lung cancer after surgery. The medicine is meant to help prevent the cancer from coming back by blocking the ROS1 protein and related proteins that tell cancer cells to grow. It belongs to the class of medicines called tyrosine‑kinase inhibitors.

  • Placebo matching Taletrectinib capsules

    The placebo looks like a Taletrectinib capsule but contains no active drug and is taken orally. It is not a medicine and is used only as a control in clinical studies to compare the effects of the real drug. Because it has no active ingredients, it has no therapeutic use, mechanism of action, or drug class. It simply helps researchers see whether Taletrectinib works better than doing nothing.

Investigated diseases

Non‑Small Cell Lung Cancer - It is a type of lung tumor that begins in the larger airways and surrounding lung tissue. The cancer cells usually grow more slowly than those of small cell lung cancer. Over time the tumor can enlarge and invade nearby structures such as the bronchi and blood vessels. It may also spread through the bloodstream to other parts of the body, forming new growths. The disease often progresses in stages, starting with a localized mass and potentially advancing to regional and distant involvement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521971-29-00Protocol codeAB-106-G319Estimated enrolment180 patientsSponsorNuvation Bio Inc.

sourced from the EU Clinical Trials Register and site verification

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