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Non Small Cell Lung CancerPhase 2TRUST-IINCT04919811

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

A Phase 2 study testing Taletrectinib in people with Non Small Cell Lung Cancer, run by Nuvation Bio Inc. at 77 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Taletrectinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
217 participants
Where
77 sitesin 9 countries
Study dates
1 Sep 2021to Dec 2027
Phase
Phase 2
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years (or ≥20 years as required by local regulations).
  • Histologically or cytologically confirmed diagnosis of locally advanced (including inoperable Stage IIIA or IIIB NSCLC) or metastatic NSCLC (Cohorts 1-3, 5) or other solid tumors including NSCLC patients ineligible for other cohorts (Cohort 4).
  • Evidence of ROS1 fusion by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified or locally equivalent diagnostic laboratories. The molecular assays (i.e., Reverse Transcription Polymerase Chain Reaction [RT-PCR], Next-generation Sequencing [NGS]) are highly recommended.
  • Sufficient tumor tissue is required for patients in Cohort 1 and for TKI-naïve patients in Cohort 5 in order to perform confirmatory ROS1 fusion testing at the designated central laboratories. For patients in Cohort 1 and for TKI-naïve patients in Cohort 5, an archival tumor tissue specimen should be available and collected prior to enrollment. If archival tumor tissue is unavailable, then a fresh biopsy must be performed. Tumor tissue for patients in other cohorts is highly recommended, and tumor tissue obtained after progression on the most recent prior ROS1 TKI therapy in these cohorts is preferred. Cytology samples (e.g., pleural effusion cell pellets) may be acceptable for patients in Cohorts 2-4, and patients in Cohort 5 that received prior treatment with TKI(s) having ROS1 activity.
  • Patients with central nervous system (CNS) involvement, including leptomeningeal carcinomatosis, must be stable (either asymptomatic or previously treated and controlled are allowed:
  • Seizure prophylaxis is permitted with non-enzyme inducing anti-epileptic drugs (non-EIAEDs).
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  • Corticosteroid treatment at a stable or decreasing dose within 7 days prior to the first dose of taletrectinib.
  • Whole brain radiation therapy (WBRT) must be completed at least 14 days and stereotactic radiotherapy, stereotactic radiosurgery, or gamma knife radiotherapy at least 7 days prior to enrollment; the patient must be clinically stable for 7 days according to investigator judgement prior to first dose of taletrectinib.
  • The patient can be either ROS1 TKI treatment naïve or treated with prior ROS1 TKI(s):
  • o Cohort 1: Patients with locally advanced or metastatic ROS1-positive NSCLC. Systemic chemotherapy naïve or pretreated with 1 prior line of chemotherapy but never treated with any ROS1 TKI.
  • o Cohort 2: Patients with locally advanced or metastatic ROS1-positive NSCLC. Prior treatment with 1 approved ROS1 TKI (crizotinib or entrectinib) and disease progression. The patient can be either chemotherapy naïve or has received 1 line of systemic chemotherapy for locally advanced or metastatic ROS1-positive NSCLC.
  • Cohort 3: Patients with locally advanced or metastatic ROS1-positive NSCLC. Prior treatment with ≥2 TKIs with ROS1 activity and disease progression. The patient can be either chemotherapy naïve or has received 1 line of systemic chemotherapy for locally advanced or metastatic ROS1-positive NSCLC, patients with known ROS1 resistant mutations are preferred.
  • Cohort 4: Patients with other ROS1-positive solid tumors, or NSCLC patients ineligible for Cohorts 1-3. Prior treatment with ≤3 TKIs with ROS1 activity. The patient can be either chemotherapy naïve or has received ≤2 lines of systemic chemotherapy for locally advanced or metastatic solid tumors.
  • Cohort 5: Patients with locally advanced or metastatic ROS1-positive NSCLC. The patient can be either chemotherapy naïve or has received ≤2 lines of systemic chemotherapy line of systemic chemotherapy for locally advanced or metastatic ROS1-positive NSCLC. ROS1-TKI-naïve or pretreated with TKI(s) having ROS1 activity.
  • At least 1 measurable disease per RECIST 1.1 as assessed by the investigator.
  • Eastern Cooperative Oncology Group Performance Status: 0 or 1.
  • Patient with a life expectancy ≥12 weeks based on the judgement of investigator.
  • Patients with 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 patients with concurrent liver metastases)
  • Serum total bilirubin: ≤1.5 × ULN (≤3.0 × ULN for patients with Gilbert syndrome or if liver function abnormalities are due to underlying malignancy)
  • Absolute neutrophil count: ≥1,500/μL
  • Platelet count: ≥100,000/μL
  • Hemoglobin: ≥9.0 g/dL
  • Serum creatinine ≤1.5 × ULN and estimated creatinine clearance (CLcr) ≥45 mL/min as calculated using the method standard for the institution (e.g., Cockcroft - Gault Equation)
  • Males and/or females who meet any of the following criteria:
  • For males (irrespective of surgical sterilization [vasectomy]): agree to use effective contraception methods during the study intervention period and for at least 90 days after the last dose of investigational drug or agree with complete abstinence.
  • Females without menses for at least 1 year prior to screening or documented to be surgically sterilized. Women of childbearing potential (WOCBP) must agree to use two concurrent highly effective methods of contraception or agree with complete abstinence from sexual intercourse since the informed consent until 45 days after the last dose of investigational drug. Usage of hormonotherapy for contraception should be recorded as well.
  • For all females of childbearing potential, a negative pregnancy test must be obtained within 7 days before starting study treatment. Female patients of non childbearing potential must meet at least 1 of the following criteria:
  • ○ Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.
  • ○ Have undergone a documented hysterectomy and/or bilateral oophorectomy.
  • ○ Have medically confirmed ovarian failure. All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential.
  • The patient is willing and capable to give written informed consent.
  • The patient is willing and capable to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
  • The patient is willing and capable to comply with study site's COVID-19 policies.

Who cannot join

  • Treatment with small molecule anticancer therapy including other investigational agents or cytotoxic systemic anticancer therapy within 2 weeks (or 5 half-lives of the compound, whichever is shorter) prior to the first dose of taletrectinib; or treatment with monoclonal antibodies, including immune checkpoint inhibitors within 4 weeks before the first dose of taletrectinib.
  • Major surgical procedure, open biopsy, or significant traumatic injury ≤4 weeks before the first dose of taletrectinib.
  • Note: Placement of vascular access device is not considered major surgery. Other minor surgical procedures, such as catheter placement or minimally invasive biopsy, are allowed.
  • Radiation outside the chest and brain <7 days prior to C1D1.
  • Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
  • Adverse events due to prior therapy are unresolved to ≤ CTCAE Grade 1 or has not returned to baseline, by the first dose of taletrectinib except for AEs not constituting a safety risk to the patient based on the judgment of investigators.
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  • Patients with untreated spinal cord compression caused by tumor and/or cancerous meningitis.
  • History or evidence of interstitial fibrosis, interstitial lung disease or drug-induced pneumonitis (Excluding clinically insignificant or asymptomatic post radiation pneumonitis).
  • Any gastrointestinal disorders that may affect absorption of oral medications.
  • 1. 9. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), or severe acute respiratory syndrome coronavirus 2 (SARS CoV 2), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. Note that the following are permitted:
  • ○ Patients treated for hepatitis C (HCV) or HIV with no detectable viral load; for at least 1 month prior to the first dose of taletrectinib.
  • Note: caution with drug drug interactions of concomitant anti HIV agents and CYP3A substrates.
  • ○ Patients with known hepatitis B (HBV) infections:
  • With past or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of hepatitis B surface antigen [HBsAg]); or
  • With inactive HBV carrier state (defined as HBsAg positive, with normal ALT, and HBV DNA <2,000 IU/mL or <10,000 copies/mL).
  • Note: Please consider that, for patients in an inactive HBV carrier state or with a resolved HBV infection, there may be a risk of HBV reactivation, and anti HBV prophylaxis should be considered.
  • 10. Clinically significant cardiovascular diseases within 3 months prior to the first dose of taletrectinib: myocardial infarction, severe/unstable angina, coronary/peripheral endovascular treatment, heart failure or cerebrovascular disorder including transient ischemic attack.
  • 11. 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, or symptomatic bradycardia <45 beats per minute; patient has family or medical history of long QT syndrome.
  • 12. Pregnancy or lactation/breastfeeding. 13. Use of food or drugs that are known potent cytochrome P450 3A4/5 (CYP3A4/5) inhibitors or inducers or P-glycoprotein inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment.
  • 14. Administration of agents with potential QT interval prolonging effect within 14 days prior to first dose of study treatment and while on treatment.
  • 15. Patients with other severe medical or mental diseases in whom the risk is increased by participation to the study or treatment with study treatment in the opinion of the investigator.

Trial locations and contacts

77 sites in 9 countries.

77 sites in 9 countries

United States20 sites

  • SCRI - Hematology Oncology Clinic

    Baton Rouge, Louisiana, 70809

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Center for Cancer Research

    Brick, New Jersey, 08724

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • Renovatio Clinical

    El Paso, Texas, 19915

  • SCRI - Florida Cancer Specialists South

    Fort Meyers, Florida, 33901

  • The Oncology Institute of Hope and Innovation

    Glendale, California, 91204

  • Memorial Cancer Institute at Memorial Hospital East

    Hollywood, Florida, 33021

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 92868

  • Moores Cancer Center at UC San Diego

    La Jolla, California, 92037

  • Keck Medicine of University of Southern California

    Los Angeles, California, 90089

  • SCRI - Tennessee Oncology

    Nashville, Tennessee, 37203

  • UCI Medical Center

    Orange, California, 92868

  • Ventura County Hematology-Oncology Specialists

    Oxnard, California, 93030

  • Memorial Cancer Institute at Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Renovatio Clinical

    The Woodlands, Texas, 77380

Other trials in United States

Spain12 sites

  • Clinica Mi Tres Torres

    Barcelona, 08017

  • Hospital Quironsalud Barcelona

    Barcelona, 08023

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • ICO l'Hospitalet - Hospital Duran i Reynals L'Hospitalet de Llobregat

    Barcelona, 08908

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Instituto Valenciano de Oncologia IVO

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

France10 sites

  • CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

    Bron

  • CHU Grenoble Alpes- Hospital Michallon

    La Tronche, 38700

  • Centre Léon Bérard

    Lyon 08, 69373

  • Centre d'Essais Précoces de Cancerologie de Marseille

    Marseille, 13005

  • APHP- Hôpital Europeen Georges Pompidou (HEGP)

    Paris, 75015

  • CHU de Poitiers Pole regional

    Poitiers, 86000

  • Institut Jean Godinot

    Reims, 51726

  • CHU Rennes - Hospital Pontchaillou

    Rennes, 35033

  • Institut De Cancérologie De L'ouest

    Saint-Herblain, 44805

  • Institut Gustave Roussy

    Saint-Herblain, 44805

Other trials in France

Italy9 sites

  • Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico

    Bari, 70124

  • Humanitas Istituto Clinico Catanese, Misterbinanoco

    Catania, 95045

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • AOU Cagliari- P.O. Policlinico Universitario Duilio Casula

    Monserrato, 09042

  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania

    Naples, 80131

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

Other trials in Italy

China8 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Hunan Cancer Hospital

    Changsha

  • West China Hospital

    Chengdu

  • Shandong Cancer Hospital

    Jinan

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • Wuhan Union Hospital

    Wuhan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

Japan8 sites

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • National Cancer Center Hospital East

    Kashiwa, 104-0045

  • Sendai Kousei Hospital

    Miyagi, 980-0873

  • Aichi Cancer Center Hospital

    Nagoya, 464-8681

  • Kindai University Hospital

    Osaka, 589-8511

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

Other trials in Japan

South Korea5 sites

  • Pusan National University Hospital

    Busan, 49241

  • Pusan National University Yangsan Hospital

    Gyeongsang, 999007

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128

  • Asan Medical Center

    Seoul, 05505

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Poland3 sites

  • Instytut Centrum Zdrowia Matki Polki

    Lodz

  • Med-Polonia Sp. z o.o.

    Poznan, 60-693

  • MICS Centrum Medyczne Toruńa

    Torun, 87-100

Other trials in Poland

Canada2 sites

  • McGill University Health Centre Research Institute

    Montreal, Quebec

  • Princess Margaret Cancer Centre

    Toronto, Ontario

Other trials in Canada

About this study

Official title: A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients With Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors

The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.

Read the detailed description

This is a global Phase 2, multicenter, single-arm, open label study of taletrectinib in patients of NSCLC harboring with ROS1 fusion gene.

About 214 patients will be enrolled and divided into 5 cohorts, depending on past history of ROS1 TKI treatment.

Taletrectinib is administered once daily in 21-day cycles. Patients will continue with the treatment on taletrectinib until progression of disease as determined by the investigator.

The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow-up will also be conducted.

Being tested
Taletrectinib
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

    Also called DS-6051b, AB-106

    400mg or 600mg QD

Study groups in NCT04919811
Study groupRoleWhat they receive
TaletrectinibExperimentalSingle-arm trial whereby all consented, enrolled, eligible patients receive taletrectinib
Receives: Drug: Taletrectinib

What is being measured

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

  1. Objective response rate (ORR) by independent radiology review committee (IRC)

    Confirmed ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by an independent radiology review committee (IRC)

    Measured: Up to 4 years

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    PFS according to RECIST 1.1 assessed by IRC

    Measured: Up to 4 years

  2. Objective response rate (ORR) assessed by investigators

    ORR according to RECIST 1.1 assessed by investigators

    Measured: Up to 4 years

  3. Safety and tolerability of taletrectinib

    Incidence of Adverse events (AEs), incidence of laboratory abnormalities, incidence of abnormal vital signs, abnormal ECG and abnormal ophthalmologic findings

    Measured: Up to 4 years

  4. Pharmacokinetic (PK) profile of taletrectinib

    Maximum Plasma Concentration (Cmax) of taletrectinib

    Measured: Up to 4 years

Timeline

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

  1. First posted9 Jun 2021
  2. Study start1 Sep 2021
  3. Primary completion11 Jun 2025
  4. Study completionDec 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04919811
Sponsor's protocol ID
AB-106-G208
Acronym
TRUST-II
Status last verified
Oct 2025
First submitted
27 May 2021
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Perol M, Li W, Pennell NA, Liu G, Ohe Y, De Braud F, Nagasaka M, Felip E, Xiong A, Zhang Y, Fan H, Wang X, Li S, Lai RK, Ran F, Zhang X, Chen W, Bazhenova L, Zhou C. Taletrectinib in ROS1+ Non-Small Cell Lung Cancer: TRUST. J Clin Oncol. 2025 Jun;43(16):1920-1929. doi: 10.1200/JCO-25-00275. Epub 2025 Apr 3.

    PubMed 40179330

  • Nagasaka M, Ohe Y, Zhou C, Choi CM, Yang N, Liu G, Felip E, Perol M, Besse B, Nieva J, Raez L, Pennell NA, Dimou A, Marinis F, Ciardiello F, Seto T, Hu Z, Pan M, Wang W, Li S, Ou SI. TRUST-II: a global phase II study of taletrectinib in ROS1-positive non-small-cell lung cancer and other solid tumors. Future Oncol. 2023 Jan;19(2):123-135. doi: 10.2217/fon-2022-1059. Epub 2023 Mar 6.

    PubMed 36877099

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Taletrectinib in people with Non Small Cell Lung Cancer, run by Nuvation Bio Inc. at 77 sites in 9 countries.

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 34 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Spain, France, Italy, China and 4 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) by independent radiology review committee (IRC) (time frame: Up to 4 years). 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 NCT04919811, which also lists 2 linked publications.

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 7 Jan 2026.

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TRUST-II Clinical Trial NCT04919811 | AzTrials