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Taletrectinib versus placebo as adjuvant therapy for ROS1-positive early-stage non-small cell lung cancer

A Phase 3 Multicenter Double-blind Randomized Study of Taletrectinib Versus Placebo in Patients With ROS1-Fusion Positive Stage IB-IIIA Non-Small Cell Lung Cancer Who Have Undergone Complete Tumor Resection

Phase 3 Interventional Nuvation Bio Inc. · NCT07154706

This study will test whether taking taletrectinib after surgery can help prevent cancer from coming back in adults whose early-stage NSCLC tumors have a ROS1 fusion.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorNuvation Bio Inc. Industry-sponsored
Drugs / interventionschemotherapy, radiation, taletrectinib
Locations29 sites (Los Angeles, California and 28 other locations)
Trial IDNCT07154706 on ClinicalTrials.gov

What this trial studies

This is a phase 3, multicenter, double-blind, randomized trial comparing oral taletrectinib to placebo as adjuvant therapy in adults with ROS1-rearranged stage IB, II, or IIIA non-small cell lung cancer after curative-intent surgery. Eligible participants must have a documented ROS1 rearrangement by an accredited local test and provide tissue for central confirmation unless local and central assays are identical and conducted in a CLIA-equivalent lab. Participants are randomized to receive taletrectinib or matching placebo and followed for cancer recurrence and safety outcomes. The trial is being conducted at multiple U.S. cancer centers including UCLA, UCI Chao Family Comprehensive Cancer Center, and Georgetown University Medical Center.

Who should consider this trial

Good fit: Adults (age ≥18 or as locally required) with histologically confirmed stage IB, II, or IIIA NSCLC, a documented ROS1 rearrangement, ECOG 0-1, who have had definitive curative surgery and can provide tumor tissue for testing are the ideal candidates.

Not a fit: Patients without a ROS1 fusion, those with more advanced disease than stage IIIA, or those who have not had curative surgical resection are unlikely to benefit from this adjuvant therapy.

Why it matters

Potential benefit: If successful, taletrectinib could lower the risk of cancer recurrence after surgery for patients with ROS1-positive early-stage NSCLC.

How similar studies have performed: ROS1-targeted drugs have shown clear benefit in advanced, metastatic ROS1-positive NSCLC, but using a ROS1 inhibitor as adjuvant therapy after surgery is a newer approach that has not yet been proven.

Eligibility criteria

Show full inclusion / exclusion 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 available for prospective central laboratory confirmatory testing. Confirmation of central test positivity is required prior to Randomization.

   Note: In the event that the local testing assay is the same as the central testing assay, and the local test was conducted in a CLIA-certified laboratory or local equivalent, prospective central confirmation is not needed, but tumor tissue must still be provided for other biomarker studies.
4. Age ≥18 years (or ≥20 years as required by local regulations).
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Received definitive locoregional curative surgery for stage IB, II, or IIIA NSCLC. All surgical margins of resection must be negative for tumor.
7. Complete recovery from surgery (including complete wound healing) that was performed ≥4 weeks but no more than 16 weeks before Randomization if no adjuvant chemotherapy was given. Surgery must have occurred ≥4 weeks but no more than 30 weeks prior to Randomization if adjuvant chemotherapy was given. For participants who received post-resection adjuvant chemotherapy, the final dose of chemotherapy must also have occurred at least 7 days before Randomization. All chemotherapy related toxicities must have resolved to baseline or ≤Grade 1 (per CTCAE v5.0) prior to Randomization.

Exclusion Criteria:

1. Has previously received 1 or more of the following cancer treatments:

   1. Postoperative or planned radiation therapy for the current lung cancer. Note: radiotherapy in the neoadjuvant setting is allowed and must be completed at least 4 weeks prior to Randomization.
   2. Any adjuvant anticancer therapy (including investigational therapy) for treatment of NSCLC other than standard postoperative platinum-based doublet chemotherapy. Participants should have received no more than 4 cycles of the platinum doublet regimen.

      Notes: Adjuvant immune checkpoint inhibitor (ICI) treatment is allowed, but participants should have received no more than 4 cycles of the ICI, and at the time of Randomization, have at least 12 weeks of washout from the last dose of the ICI. Any prior immune-related toxicity, such as immune-related hepatitis, colitis, or pneumonitis, must be completely resolved prior to Randomization.
   3. Neoadjuvant chemotherapy with or without ICIs is allowed. Those treated with prior ICIs are eligible if ≥12 weeks have elapsed after completion of the ICI at the time of Randomization. Any prior immune-related toxicity (if an ICI was given), such as immune-related hepatitis, colitis, or pneumonitis, must be completely resolved prior to Randomization.
   4. Major surgery (including surgical resection of the primary tumor but excluding placement of vascular access port) within 4 weeks of Randomization.
   5. Segmentectomies or wedge resections, instead of complete resections, of the primary tumor. Note: These limited resections are allowed for patients with stage IB disease with T2aN0M0, with tumor size \>3 to ≤4 cm, and without visceral pleura or central invasion.
2. Any investigational therapy for any condition other than NSCLC within 6 months of Randomization.
3. Co-mutations of epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) fusion.
4. History of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in situ cancer, or other tumors curatively treated with no evidence of disease for \>3 years after the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
5. Have clinically significant cardiovascular disease within 3 months prior to Randomization.
6. Have a known history of uncontrolled hypertension.
7. Experiencing ongoing cardiac dysrhythmias of ≥Grade 2 (CTCAE v5.0), uncontrolled atrial fibrillation of any CTCAE grade, a QT interval corrected by Fridericia's formula (QTcF) of \>470 milliseconds, symptomatic bradycardia \<45 bpm; undergoing treatment with medication(s) known to be associated with the development of Torsades de Pointes (TdP).
8. Have active and clinically significant bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV); or known human immunodeficiency virus (HIV)- or acquired immunodeficiency syndrome-related illness.
9. Currently have or have a history of interstitial lung disease (ILD), drug-related pneumonitis, or radiation pneumonitis that required steroid treatment.
10. Use of food or drugs that are known as strong cytochrome P450 (CYP)3A inducers or inhibitors within 14 days prior to Randomization.

Where this trial is running

Los Angeles, California and 28 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung CancerNSCLCAdjuvantROS1Stage IBStage IIStage IIIAResection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.