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New lung cancer drug aims to outperform current standard in advanced ROS1-positive patients

NCT ID NCT06564324

Disease control Sponsor: Nuvation Bio Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, taletrectinib, against the current standard drug crizotinib in people with a specific type of advanced lung cancer (ROS1-positive NSCLC) who have not had targeted therapy before. About 194 participants will be randomly assigned to take either taletrectinib or crizotinib daily. The main goal is to see which drug better delays cancer growth or death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 194 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of locally advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC. 2. Have documentation of ROS1 rearrangement by a positive result 3. Have at least 1 measurable (i.e., target) lesion by Investigator assessment per RECIST v1.1. 4. Prior brain metastases allowed if asymptomatic and diagnosed incidentally at study baseline. If participants have neurological symptoms or signs due to CNS metastasis, participants need to complete local therapy (surgery and/or radiation) at least 7 days before enrollment and be clinically stable without requiring for an increasing dose of corticosteroids or use of anticonvulsants to control symptoms. 5. Age ≥18 years (or ≥20 years as required by local regulations). 6. Eastern Cooperative Oncology Group (ECOG) performance status zero (0) to 1. 7. Minimum life expectancy of 3 months or more. 8. Adequate organ function meeting the following criteria: 1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): ≤3.0 × upper limit of normal (ULN) (or ≤5.0 × ULN, for participants with concurrent liver metastases). 2. Serum total bilirubin: ≤1.5 × ULN (≤3.0 × ULN for participants with Gilbert syndrome). 3. Absolute neutrophil count: ≥1500/μL. 4. Platelet count: ≥75,000/μL. 5. Hemoglobin: ≥9.0 g/dL. 6. Estimated creatinine clearance (CLcr) ≥45 mL/min as calculated using the method standard for the institution (e.g., Cockcroft-Gault Equation, i.e., CCr={((140-age)×weight)/(72×SCr)}×0.85 (if female) (Cockcroft and Gault 1976). 9. All toxicities from prior anticancer therapy have resolved to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0), or have resolved to previous baseline, at the time of randomization. 10. The participant is willing and capable of giving written informed consent. Exclusion Criteria: 1. Previously received an investigational antineoplastic agent for NSCLC. 2. Previously received any prior TKI, including ROS1-targeted TKIs. 3. Received immune checkpoint inhibitors for locally advanced or metastatic disease. 4. Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease. 5. Had major surgery within 28 days prior to randomization. Minor surgical procedures, such as catheter placement or minimally invasive biopsy, are allowed. 6. Have symptomatic CNS metastases at Screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days prior to randomization. Participants with no prior history of signs or symptoms of CNS metastases but who receive prophylactic steroids or anticonvulsants are allowed. 7. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed. 8. Uncontrolled pleural, abdominal, or pericardial effusion within 28 days prior to randomization, which is associated with malignant effusion requiring recurrent drainage procedures (once monthly or more frequently). 9. Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated nonmelanoma skin cancer or cervical cancer in situ; definitively treated nonmetastatic prostate cancer; or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy. 10. Have clinically significant cardiovascular diseases within 6 months prior to randomization: myocardial infarction, severe/unstable angina, coronary/peripheral endovascular treatment, heart failure, cerebrovascular disorder including transient ischemic attack, pulmonary embolism, deep venous thrombosis and or other clinically significant thrombosis. 11. Have a known history of uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure. 12. Have ongoing cardiac dysrhythmias of ≥CTCAE Grade 2, uncontrolled atrial fibrillation of any grade, or QT interval corrected for heart rate by Fredericia's formula (QTcF) \>470 milliseconds (female) or \>450 milliseconds (male), or symptomatic bradycardia \<45 bpm within 6 months before enrollment; participants treated with medications known to be associated with the development of TdP . 13. Have active and clinically significant bacterial, fungal, or viral infection including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), known HIV or AIDS-related illness 14. Currently have or have a history of interstitial lung disease (ILD), drug-related pneumonitis, or radiation pneumonitis that required steroid treatment. 15. Be pregnant or breastfeeding

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Cancer Hospital of Shandong First Medical University

    RECRUITING

    Jinan, Shangdong, China

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, Guangxi, China

  • Henan Cancer Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Linyi Cancer Hospital

    RECRUITING

    Linyi, Shandong, China

  • Shanghai East Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Shanxi Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, China

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi’an, Shanxi, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, China

  • Tianjin Cancer Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Yunnan Cancer Hospital

    NOT_YET_RECRUITING

    Kunming, Yunnan, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, China

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