Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC
NCT ID: NCT04919811
Last Updated: 2026-01-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
217 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-09-01
Study Completion Date
2027-12-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Non Small Cell Lung Cancer
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Taletrectinib
Single-arm trial whereby all consented, enrolled, eligible patients receive taletrectinib
Group Type
EXPERIMENTAL
Taletrectinib
Intervention Type
DRUG
400mg or 600mg QD
Interventions
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Taletrectinib
400mg or 600mg QD
Intervention Type
DRUG
Other Intervention Names
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DS-6051b
AB-106
Eligibility Criteria
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Inclusion Criteria
1. Age ≥18 years (or ≥20 years as required by local regulations).
2. 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).
3. 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.
4. 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.
5. 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).
* 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.
6. 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.
7. At least 1 measurable disease per RECIST 1.1 as assessed by the investigator.
8. Eastern Cooperative Oncology Group Performance Status: 0 or 1.
9. Patient with a life expectancy ≥12 weeks based on the judgement of investigator.
10. Patients with 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 patients with concurrent liver metastases)
2. Serum total bilirubin: ≤1.5 × ULN (≤3.0 × ULN for patients with Gilbert syndrome or if liver function abnormalities are due to underlying malignancy)
3. Absolute neutrophil count: ≥1,500/μL
4. Platelet count: ≥100,000/μL
5. Hemoglobin: ≥9.0 g/dL
6. 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)
11. Males and/or females who meet any of the following criteria:
a. 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.
b. 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.
12. 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.
13. The patient is willing and capable to give written informed consent.
14. The patient is willing and capable to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
15. The patient is willing and capable to comply with study site's COVID-19 policies.
2. 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).
3. 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.
4. 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.
5. 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).
* 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.
6. 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.
7. At least 1 measurable disease per RECIST 1.1 as assessed by the investigator.
8. Eastern Cooperative Oncology Group Performance Status: 0 or 1.
9. Patient with a life expectancy ≥12 weeks based on the judgement of investigator.
10. Patients with 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 patients with concurrent liver metastases)
2. Serum total bilirubin: ≤1.5 × ULN (≤3.0 × ULN for patients with Gilbert syndrome or if liver function abnormalities are due to underlying malignancy)
3. Absolute neutrophil count: ≥1,500/μL
4. Platelet count: ≥100,000/μL
5. Hemoglobin: ≥9.0 g/dL
6. 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)
11. Males and/or females who meet any of the following criteria:
a. 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.
b. 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.
12. 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.
13. The patient is willing and capable to give written informed consent.
14. The patient is willing and capable to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
15. The patient is willing and capable to comply with study site's COVID-19 policies.
Exclusion Criteria
1. 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.
2. 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.
3. Radiation outside the chest and brain \<7 days prior to C1D1.
4. 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.
5. 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.
6. Patients with untreated spinal cord compression caused by tumor and/or cancerous meningitis.
7. History or evidence of interstitial fibrosis, interstitial lung disease or drug-induced pneumonitis (Excluding clinically insignificant or asymptomatic post radiation pneumonitis).
8. 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.
2. 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.
3. Radiation outside the chest and brain \<7 days prior to C1D1.
4. 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.
5. 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.
6. Patients with untreated spinal cord compression caused by tumor and/or cancerous meningitis.
7. History or evidence of interstitial fibrosis, interstitial lung disease or drug-induced pneumonitis (Excluding clinically insignificant or asymptomatic post radiation pneumonitis).
8. 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Nuvation Bio Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Wei Wang, MD, PhD
Role: STUDY_DIRECTOR
Nuvation Bio Inc.
Locations
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Beverly Hills Cancer Center
Beverly Hills, California, United States
Site Status
The Oncology Institute of Hope and Innovation
Glendale, California, United States
Site Status
Moores Cancer Center at UC San Diego
La Jolla, California, United States
Site Status
Keck Medicine of University of Southern California
Los Angeles, California, United States
Site Status
UCI Medical Center
Orange, California, United States
Site Status
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States
Site Status
SCRI - Florida Cancer Specialists South
Fort Meyers, Florida, United States
Site Status
Memorial Cancer Institute at Memorial Hospital East
Hollywood, Florida, United States
Site Status
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Site Status
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida, United States
Site Status
SCRI - Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
Site Status
Mayo Clinic
Rochester, Minnesota, United States
Site Status
Center for Cancer Research
Brick, New Jersey, United States
Site Status
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Site Status
SCRI - Tennessee Oncology
Nashville, Tennessee, United States
Site Status
Texas Oncology, P.A.
Dallas, Texas, United States
Site Status
Renovatio Clinical
El Paso, Texas, United States
Site Status
MD Anderson Cancer Center
Houston, Texas, United States
Site Status
Renovatio Clinical
The Woodlands, Texas, United States
Site Status
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Site Status
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Site Status
McGill University Health Centre Research Institute
Montreal, Quebec, Canada
Site Status
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Site Status
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Site Status
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Site Status
Hunan Cancer Hospital
Changsha, , China
Site Status
West China Hospital
Chengdu, , China
Site Status
Shandong Cancer Hospital
Jinan, , China
Site Status
Wuhan Union Hospital
Wuhan, , China
Site Status
Henan Cancer Hospital
Zhengzhou, , China
Site Status
CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
Bron, , France
Site Status
CHU Grenoble Alpes- Hospital Michallon
La Tronche, , France
Site Status
Centre Léon Bérard
Lyon 08, , France
Site Status
Centre d'Essais Précoces de Cancerologie de Marseille
Marseille, , France
Site Status
APHP- Hôpital Europeen Georges Pompidou (HEGP)
Paris, , France
Site Status
CHU de Poitiers Pole regional
Poitiers, , France
Site Status
Institut Jean Godinot
Reims, , France
Site Status
CHU Rennes - Hospital Pontchaillou
Rennes, , France
Site Status
Institut De Cancérologie De L'ouest
Saint-Herblain, , France
Site Status
Institut Gustave Roussy
Saint-Herblain, , France
Site Status
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico
Bari, , Italy
Site Status
Humanitas Istituto Clinico Catanese, Misterbinanoco
Catania, , Italy
Site Status
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Site Status
Ospedale San Raffaele
Milan, , Italy
Site Status
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Site Status
IEO Istituto Europeo di Oncologia
Milan, , Italy
Site Status
AOU Cagliari- P.O. Policlinico Universitario Duilio Casula
Monserrato, , Italy
Site Status
Azienda Ospedaliera Universitaria- Università degli Studi della Campania
Napoli, , Italy
Site Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Site Status
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Site Status
National Cancer Center Hospital East
Kashiwa, , Japan
Site Status
Sendai Kousei Hospital
Miyagi, , Japan
Site Status
Aichi Cancer Center Hospital
Nagoya, , Japan
Site Status
Kindai University Hospital
Osaka, , Japan
Site Status
Shizuoka Cancer Center
Shizuoka, , Japan
Site Status
National Cancer Center Hospital
Tokyo, , Japan
Site Status
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Site Status
Instytut Centrum Zdrowia Matki Polki
Lodz, , Poland
Site Status
Med-Polonia Sp. z o.o.
Poznan, , Poland
Site Status
MICS Centrum Medyczne Toruńa
Torun, , Poland
Site Status
Pusan National University Hospital
Busan, , South Korea
Site Status
Pusan National University Yangsan Hospital
Gyeongsang, , South Korea
Site Status
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Site Status
Asan Medical Center
Seoul, , South Korea
Site Status
Korea University Guro Hospital
Seoul, , South Korea
Site Status
Clinica Mi Tres Torres
Barcelona, , Spain
Site Status
Hospital Quironsalud Barcelona
Barcelona, , Spain
Site Status
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Site Status
ICO l'Hospitalet - Hospital Duran i Reynals L'Hospitalet de Llobregat
Barcelona, , Spain
Site Status
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Site Status
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Site Status
Hospital Universitario 12 de Octubre
Madrid, , Spain
Site Status
Hospital Universitario La Paz
Madrid, , Spain
Site Status
Hospital Regional Universitario de Malaga
Málaga, , Spain
Site Status
Hospital Universitario Virgen Macarena
Seville, , Spain
Site Status
Instituto Valenciano de Oncologia IVO
Valencia, , Spain
Site Status
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Site Status
Countries
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United States
Canada
China
France
Italy
Japan
Poland
South Korea
Spain
References
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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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
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AB-106-G208
Identifier Type: -
Identifier Source: org_study_id
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RECRUITING
PHASE2
Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer
NCT03607188
COMPLETED
PHASE1
Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer
NCT05991895
RECRUITING
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
NCT01260181
COMPLETED
PHASE2
A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1
NCT05276726
RECRUITING
PHASE1/PHASE2
Study of HS-10241 in Combination With Almonertinib in Patients With Locally Advanced or Metastatic NSCLC
NCT05430386
UNKNOWN
PHASE1
A Study of TAS3351 in NSCLC Patients With EGFRmt
NCT05765734
TERMINATED
PHASE1/PHASE2
A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT01996332
COMPLETED
PHASE2
Phase I/IIa Study of H002 in NSCLC With Active EGFR Mutation
NCT05519293
RECRUITING
PHASE1/PHASE2
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy.
NCT00773383
TERMINATED
PHASE2
Surufatinib Combined With Toripalimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer
NCT05003037
UNKNOWN
PHASE2
Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC
NCT06552234
RECRUITING
PHASE2
Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations
NCT06054191
NOT_YET_RECRUITING
PHASE2
Crizotinib in Pretreated Metastatic Non-small-cell Lung Cancer With MET Amplification or ROS1 Translocation (METROS)
NCT02499614
UNKNOWN
PHASE2
Phase 1/2 Study of HS-10376 in Patients With Non-Small Cell Lung Cancer
NCT05435274
UNKNOWN
PHASE1/PHASE2
An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT00949910
COMPLETED
PHASE4
Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
NCT06613009
RECRUITING
PHASE1
The Efficacy and Drug Resistance Molecular Biology of Apatinib Combined With EGFR-TK1 Treated for Advanced Slow-progressed Non-Small Cell Lung Cancer (NSCLC)
NCT03811054
UNKNOWN
PHASE2
Study on the Mechanism of Acquired Resistance of Entrectinib
NCT07199959
RECRUITING
S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer
NCT03823118
COMPLETED
PHASE2
Study to Evaluate D-1553 in Subjects With Lung Cancer
NCT05383898
COMPLETED
PHASE1/PHASE2
A Study to Evaluate Safety, PK and Efficacy of HS-10296 in Patients With NSCLC
NCT02981108
UNKNOWN
PHASE1/PHASE2
Study of Lorlatinib in ROS1 Rearranged NSCLC
NCT03612154
UNKNOWN
PHASE2