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Non Small Cell Lung CancerPhase 3NCT06564324

A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients

A Phase 3 study testing Taletrectinib and Crizotinib in people with Non Small Cell Lung Cancer, run by Nuvation Bio Inc. at 29 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase 3, randomized, open-label, comparative, multicenter, international study for NSCLC patients whose tumor tissue exhibits ROS1 fusion positivity (i.e., ROS1+) and who have not previously received an ROS1-targeted TKI (i.e., ROS1-TKI-naïve). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Taletrectinib and Crizotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
29 sitesChina
Study dates
27 Nov 2024to Sep 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of locally advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC.
  • Have documentation of ROS1 rearrangement by a positive result
  • Have at least 1 measurable (i.e., target) lesion by Investigator assessment per RECIST v1.1.
  • 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.
  • Age ≥18 years (or ≥20 years as required by local regulations).
  • Eastern Cooperative Oncology Group (ECOG) performance status zero (0) to 1.
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  • Minimum life expectancy of 3 months or more.
  • Adequate organ function meeting the following criteria:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): ≤3.0 × upper limit of normal (ULN) (or ≤5.0 × ULN, for participants with concurrent liver metastases).
  • Serum total bilirubin: ≤1.5 × ULN (≤3.0 × ULN for participants with Gilbert syndrome).
  • Absolute neutrophil count: ≥1500/μL.
  • Platelet count: ≥75,000/μL.
  • Hemoglobin: ≥9.0 g/dL.
  • 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).
  • 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.
  • The participant is willing and capable of giving written informed consent.

Who cannot join

  • Previously received an investigational antineoplastic agent for NSCLC.
  • Previously received any prior TKI, including ROS1-targeted TKIs.
  • Received immune checkpoint inhibitors for locally advanced or metastatic disease.
  • Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
  • Had major surgery within 28 days prior to randomization. Minor surgical procedures, such as catheter placement or minimally invasive biopsy, are allowed.
  • 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.
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  • Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Participants with leptomeningeal disease and without cord compression are allowed.
  • 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).
  • 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.
  • 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.
  • Have a known history of uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure.
  • 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 .
  • 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
  • Currently have or have a history of interstitial lung disease (ILD), drug-related pneumonitis, or radiation pneumonitis that required steroid treatment.
  • Be pregnant or breastfeeding

Trial locations and contacts

29 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ying Zhao contact

+86 13466689296

Ying.Zhao@nuvationbio.com

29 sites in 1 country

China29 sites, 29 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Jun Zhao, MD

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Jianchun Duan

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Yongchang Zhang, MD

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Feng Luo

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

    Huiwen Ma

    Recruiting

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong

    Xicheng Wang

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Chengzhi Zhou

    Recruiting

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

    Hangzhou, Zhejiang

    Yong Fang

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Yun Fan

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Yiruo Zhang

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shangdong

    Linlin Wang, MD

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan

    Gaofeng Li

    Not yet recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong

    Jianhua Shi

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Jianjun Tang

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

    Renhua Guo

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi

    Qitao Yu, MD

    Yun Zhao, MD

    Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality

    Caicun Zhou, MD

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality

    Shengxiang Ren, MD

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality

    Yuanlin Song

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning

    Bo Jin, MD

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Cuimin Ding

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Chuanyong Mu

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi

    Wei Guo

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality

    Peng Chen

    Recruiting

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

    Wuhan, Hubei

    Qian Chu, MD

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

    Yu Yao, MD

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Jingxun Wu, MD

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Qiming Wang

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Huijie Fan, MD

    Recruiting

Other trials in China

About this study

Official title: A Phase 3 Multicenter Open-label Study of Taletrectinib Versus a Standard of Care ROS1-Tyrosine Kinase Inhibitor (Crizotinib) in TKI-Naïve Patients With ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRUST-III)

This is a Phase 3, randomized, open-label, comparative, multicenter, international study for NSCLC patients whose tumor tissue exhibits ROS1 fusion positivity (i.e., ROS1+) and who have not previously received an ROS1-targeted TKI (i.e., ROS1-TKI-naïve).

Approximately 194 ROS-1 TKI- naïve ROS1+NSCLC patients will be randomized in a 1:1 ration to one of 2 study arms:

Read more
  • Arm A: Taletrectinib monotherapy at 600 mg once daily (QD);
  • Arm B: Crizotinib monotherapy at 250 mg twice daily (BID). Each cycle duration will be 28 days.

Participants will be stratified by the presence of intracranial metastases at baseline (Yes versus No) and prior chemotherapy use for locally advanced or metastatic disease (Yes versus No). For the purposes of stratification, prior chemotherapy is defined as completion of ≥1 cycle of chemotherapy in the locally advanced or metastatic setting. Participants will be treated until they experience progressive disease (PD) assessed by the BIRC, intolerable toxicity, or another discontinuation criterion is met. Crossover from control group (crizotinib) to taletrectinib is also permitted, at the Investigator's discretion with the Sponsor's approval, for qualifying participants who have experienced objective progression confirmed by the BIRC.

Being tested
Taletrectinib, Crizotinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TaletrectinibDrug

    Approximately 194 ROS-1TKI- naïve ROS1+NSCLC patients will be randomized in a 1:1 ration to one of 2 study arms: Arm A: Taletrectinib monotherapy at 600 mg once daily (QD); Arm B: Crizotinib monotherapy at 250 mg twice daily (BID).

    Each cycle duration will be 28 days. Participants will be treated until they experience progressive disease (PD) assessed by the blinded Independent Review Committee (BIRC), intolerable toxicity, or another discontinuation criterion is met.

  • CrizotinibDrug

    Approximately 194 ROS-1TKI- naïve ROS1+NSCLC patients will be randomized in a 1:1 ration to one of 2 study arms: Arm A: Taletrectinib monotherapy at 600 mg once daily (QD); Arm B: Crizotinib monotherapy at 250 mg twice daily (BID).

    Each cycle duration will be 28 days. Participants will be treated until they experience progressive disease (PD) assessed by the blinded Independent Review Committee (BIRC), intolerable toxicity, or another discontinuation criterion is met. Crossover from control group (crizotinib) to taletrectinib is also permitted, at the Investigator's discretion with the Sponsor's approval, for qualifying participants who have experienced objective progression confirmed by the BIRC.

Study groups in NCT06564324
Study groupRoleWhat they receive
TaletrectinibExperimental97 ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer patients will be enrolled in Arm A and treated with talerectinib
Receives: Drug: Taletrectinib
CrizotinibActive comparator97 ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer patients will be enrolled in Arm B and treated with Crizotinib
Receives: Drug: Crizotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS (Assessed by BIRC)

    Progression-Free-Survival, The time between the beginning of treatment and the occurrence of disease progression or death. Assessed by the blinded Independent Review Committee (BIRC), per RECIST v1.1

    Measured: About 49 months

Secondary outcomes (16)

  1. PFS (Assessed by investigator)

    Progression-Free-Survival is defined as the time between the beginning of treatment and the occurrence of disease progression or death. Assessed by the investigator, per RECIST v1.1 criteria.

    Measured: About 69months

  2. ORR

    Proportion of subjects with the best overall confirmed response of complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.

    Measured: About 69 months

  3. DOR

    Defined as the time from the first date of objective response (CR or PR) to the first documented date of disease progression. Response assessments are per RECIST v1.1 criteria.

    Measured: About 69 months

  4. DCR

    Defined as the proportion of subjects with a best overall response of CR, PR or stable disease per RECIST v1.1 criteria) as assessed by the investigator

    Measured: About 69 months

  5. TTR

    Defined as the overall time from the time of tumor occurrence to the patient's death. Response assessments are per RECIST v1.1 criteria.

    Measured: About 69 months

  6. OS

    Defined as the time from the first dose to death due to any cause.

    Measured: About 69 months

  7. IC-TTP

    Defined as the overall time from the time of tumor occurrence with CNS(central nervous system) metastases to the patient's death, Assessed by the BIRC, per mRECIST v1.1 criteria.

    Measured: About 69 months

  8. IC-ORR

    Proportion of CNS metastatic subjects with the best overall confirmed response of complete response (CR) or partial response (PR), Assessed by the BIRC, per mRECIST v1.1 criteria.

    Measured: About 69 months

  9. IC-DOR

    Defined as the time from the first date of objective response (CR or PR) to the first documented date of disease progression on CNS metastatic subjects. Assessed by the BIRC, per mRECIST v1.1 criteria.

    Measured: About 69 months

  10. IC-PFS

    Defined as the time between the beginning of treatment and the occurrence of disease progression or death on CNS metastatic subjects, Assessed by the BIRC, per mRECIST v1.1 criteria

    Measured: About 69 months

  11. IC-PR at 6, 12, 18, 24, and 36 months

    Partial response at 6, 12, 18, 24, and 36 months on CNS metastatic subjects, Assessed by the BIRC, per mRECIST v1.1 criteria.

    Measured: About 69 months

  12. AE

    Adverse event, including the events reported following physical examination, vital signs assessment, clinical laboratory assessment or electrocardiogram(ECG)

    Measured: About 69 months

  13. Taletrectinib concentration in plasma

    Defined as the relationship between taletrectinib concentration and time in the body

    Measured: About 12 months, at the begining of cycle 1, cycle 2, cycle 7 and cycle 12（each cycle is 28 days）

  14. patient-reported outcomes(PRO) assessed by EORTC QLQ-C30

    Patient-reported outcomes of health-related quality of life, assessed by EORTC QLQ-C30, the single-item measures range in score from 0 to 4 or 7, a high score for a symptom scale represents a high level of symptomatology / problems.

    Measured: About 69 months

  15. PRO assessed by EORTC QLQ-L13

    Patient-reported outcomes of health-related quality of life, assessed by EORTC QLQ-LC13, the single-item measures range in score from 0 to 4, a high score for a symptom scale represents a high level of symptomatology / problems.

    Measured: About 69 months

  16. PRO assessed by EQ-5D-5L

    Patient-reported outcomes of health-related quality of life, assessed by EQ-5D-5L, the scale measures range in score from 0 to 100, a high score for the health status represents a high quality of life.

    Measured: About 69 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2024
  2. Study start27 Nov 2024
  3. Primary completionJan 2029 (estimated)
  4. Study completionSep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
194 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06564324
Sponsor's protocol ID
AB-106-G318
Status last verified
Apr 2026
First submitted
12 Aug 2024
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Taletrectinib and Crizotinib in people with Non Small Cell Lung Cancer, run by Nuvation Bio Inc. at 29 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ying Zhao (+86 13466689296, Ying.Zhao@nuvationbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (Assessed by BIRC) (time frame: About 49 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06564324.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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