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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05170204




Registration number
NCT05170204
Ethics application status
Date submitted
22/12/2021
Date registered
27/12/2021

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)
Scientific title
A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
BO42777
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alectinib
Treatment: Drugs - Entrectinib
Treatment: Drugs - Durvalumab

Experimental: Cohort A1: ALK-Positive (alectinib arm) - Participants will receive alectinib 600 mg orally twice daily until completion of treatment period (3 years), or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first

Active comparator: Cohort A1: ALK-positive (durvalumab arm) - Participants will receive 1500 mg of intravenous (IV) durvalumab every 4 weeks until completion of treatment period (1 year) or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first

Experimental: Cohort A2: ROS 1-positive (entrectinib arm) - Participants will receive entrectinib 600 mg orally once daily until completion of treatment period (3 years), or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first.

Cohort A2 has been closed to enrollment.

Active comparator: Cohort A2: ROS 1-positive (durvalumab arm) - Participants will receive 1500 mg of IV durvalumab every 4 weeks until completion of treatment period (1 year) or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first

Cohort A2 has been closed to enrollment.


Treatment: Drugs: Alectinib
Participants will receive oral alectinib twice daily with food.

Treatment: Drugs: Entrectinib
Participants will receive oral entrectinib once daily, with or without food.

Treatment: Drugs: Durvalumab
Participants will receive IV durvalumab every 4 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
From randomization to the first documented disease progression as determined by blinded independent central review (BICR) per Response Evaluation Criterial in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occurs first (up to 3 years)
Secondary outcome [1] 0 0
Time-to-confirmed deterioration (TTCD)
Timepoint [1] 0 0
From randomization to the first deterioration of >/= 10 points that is either maintained for two consecutive assessments or followed by death from any cause within 3 weeks (up to 3 years)
Secondary outcome [2] 0 0
Proportion of participants who have maintained or improved baseline health as measured by the European Organisation for the Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 physical functioning and role functioning scales
Timepoint [2] 0 0
5, 11, and 17 months
Secondary outcome [3] 0 0
Proportion of participants who have maintained or improved from their baseline health in cough, chest pain, and dyspnea symptoms as measured using the EORTC QLQ-LC13
Timepoint [3] 0 0
5, 11, and 17 months
Secondary outcome [4] 0 0
Percentage of participants with adverse events (AEs)
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Time to central nervous system (CNS) progression
Timepoint [5] 0 0
From randomization to the first occurrence of disease progression in the CNS as determined by BICR per RECIST v1.1 (up to 3 years)
Secondary outcome [6] 0 0
Distant metastasis-free survival (DMFS)
Timepoint [6] 0 0
From randomization to the first occurrence of distant metastasis or death (whichever occurs first) as determined by BICR per RECIST v1.1 (up to 3 years)
Secondary outcome [7] 0 0
Objective response rate (ORR), defined as the percentage of participants with measurable disease who attain a complete response (CR) or partial response (PR) as determined by the investigator per RECIST v1.1
Timepoint [7] 0 0
Up to 3 years
Secondary outcome [8] 0 0
PFS
Timepoint [8] 0 0
From randomization to the first documented disease progression as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurs first (up to 3 years)
Secondary outcome [9] 0 0
Duration of response (DOR)
Timepoint [9] 0 0
From the first documented CR or PR to the first documented disease progression or death (whichever occurs first) as determined by the investigator per RECIST v1.1 (up to 3 years)
Secondary outcome [10] 0 0
ORR, defined as the percentage of participants with measurable disease who attain a CR or PR as determined by BICR per RECIST v1.1
Timepoint [10] 0 0
Up to 3 years
Secondary outcome [11] 0 0
DOR
Timepoint [11] 0 0
From the first documented CR or PR to the first documented disease progression or death (whichever occurs first) as determined by BICR per RECIST v1.1 (up to 3 years)
Secondary outcome [12] 0 0
Overall survival (OS)
Timepoint [12] 0 0
From randomization to death from any cause (up to 5 years)
Secondary outcome [13] 0 0
Time to CNS progression
Timepoint [13] 0 0
From randomization to the first occurrence of disease progression in the CNS as determined by the investigator per RECIST v1.1 (up to 3 years)

Eligibility
Key inclusion criteria
Inclusion Criteria (All Cohorts):

* Body weight >/= 30 kg at screening
* Willingness and ability to use the electronic device(s) or application(s) for the electronic patient-reported outcome (PRO)
* Whole-body positron emission tomography/computed tomography scan (PET/CT) (from the base of skull to mid-thighs) for the purposes of staging, performed prior and within 42 days of the first dose of cCRT or sCRT
* Histologically or cytologically documented locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
* Prior receipt of at least two prior cycles of platinum-based chemotherapy given concurrently with radiotherapy (cCRT); or at least two prior cycles of platinum-based chemotherapy given prior to radiotherapy (sCRT)
* The RT component in the cCRT or sCRT must have been at a total dose of radiation of 60 (+/-10%) Gy (54 Gy to 66 Gy) administered by intensity-modulated radiotherapy (preferred) or three dimension (3D)-conforming technique
* No disease progression during or following platinum-based cCRT or sCRT
* Life expectancy >/= 12 weeks
* Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen
* Documented tumor PD-L1 status (TC score < 1% vs. >/= 1% vs. unknown) as determined: centrally with the SP263 IHC assay on the confirmed available FFPE tumor specimen; locally, with the SP263 (preferred) or 22C3 IHC assays
* Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
* Adequate hematologic and end-organ function
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs, as defined by the protocol
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm, as defined by the protocol

Inclusion criteria specific to Cohort A1:

* Documented ALK fusion positivity by an eligible result from: centralized multiplex molecular testing of tumor tissue at the Sponsor's designated central laboratory under Study BX43361 or available results from a Sponsor pre-approved local, appropriately validated ALK fusion test on tumor tissue performed in a Clinical Laboratory Improvement Amendments certified or equivalent laboratory

Inclusion criteria specific to Cohort A2:

* Documented ROS1 fusion positivity by an eligible result from: centralized multiplex molecular testing of tumor tissue at the Sponsor's designated central laboratory under Study BX43361 or available results from a Sponsor pre-approved local, appropriately validated ROS1 fusion test on tumor tissue performed in a Clinical Laboratory Improvement Amendments certified or equivalent laboratory
* Ability to swallow entrectinib intact, without chewing, crushing, or opening the capsules
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria (All Cohorts):

* Any history of previous NSCLC and/or any history of prior treatment for NSCLC (patients must be newly diagnosed with unresectable Stage III disease)
* Any evidence of Stage IV disease, including, but not limited to, the following: pleural effusion, pericardial effusion, brain metastases, history of intracranial hemorrhage or spinal cord hemorrhage, bone metastases, distant metastases
* If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (T4 disease): when pleural fluid is visible on both the CT scan and chest X-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; participants with exudative pleural effusions are excluded regardless of cytology; participants with effusions that are minimal (i.e., not visible on chest X-ray) that are too small to safely tap are eligible
* NSCLC known to have a known or likely oncogenic-driver mutation in the EGFR gene, as identified by site local testing or Sponsor central testing
* Liver disease, characterized by any of the following: impaired excretory function (e.g., hyperbilirubinemia), synthetic function, or other conditions of decompensated liver disease, such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices or active viral or active autoimmune, alcoholic, or other types of acute hepatitis
* Positive hepatitis B surface antigen (HBsAg) test at screening
* Participants known to be positive for hepatitis C virus (HCV) antibody (Ab) are excluded with the following exception: participants who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible
* HIV infection: participants are excluded if not well-controlled as defined by the protocol
* Known active tuberculosis
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan
* Grade >/= 2 pneumonitis from prior cCRT or sCRT
* Any Grade > 2 unresolved toxicity from prior cCRT or sCRT
* Any gastrointestinal (GI) disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions: participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study; participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
* History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
* Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer
* Major surgical procedure, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment
* Treatment with investigational therapy within 28 days prior to initiation of study treatment
* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with exceptions defined by the protocol
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Prior allogeneic stem cell or solid organ transplantation
* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
* Any condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug or interpretation of patient safety or study results
* Any prior Grade >/= 3 immune-mediated adverse event or any unresolved Grade > 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents

Exclusion criteria specific to Cohort A1:

* Presence of clinically symptomatic interstitial lung disease or interstitial pneumonitis, including radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
* NSCLC known to have one or more of the following ALK point mutations, as identified by site local testing or Sponsor central testing: I1171X (where X is any other amino acid), V1180L, G1202R
* Symptomatic bradycardia
* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina; participants with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
* Prior treatment with ALK inhibitors
* History of hypersensitivity to alectinib, durvalumab, or any of their excipients
* Inability to swallow oral study drug
* Known hereditary problems of galactose intolerance, a congenital lactase deficiency, or glucose-galactose malabsorption
* Pregnancy or breastfeeding, or intending to become pregnant during the study treatment or within 90 days after the final dose of alectinib or durvalumab

Exclusion criteria specific to Cohort A2:

* Symptomatic bradycardia
* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina; participants with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
* Left ventricular ejection fraction less than or equal to 50% observed during the screening for the study
* History of prolonged QTc interval (e.g., repeated demonstration of a QTc interval > 450 ms from ECGs performed at least 24 hours apart)
* History of additional risk factors for torsade de pointes (e.g., family history of long QT syndrome)
* Familial or personal history of congenital bone disorders or bone metabolism alterations
* Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of the treatment
* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
* Prior treatment with ROS1 inhibitors
* History of hypersensitivity to entrectinib, durvalumab, and their excipients
* Grade >/= 3 toxicities due to any prior therapy (e.g., RT) (excluding alopecia) that have not shown improvement or are not stable and are considered to interfere with current study drug
* Known hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
* Grade >/= 2 peripheral neuropathy
* Pregnancy or intention of becoming pregnant during study treatment, within 35 days after the final dose of entrectinib, or within 90 days after the final dose of durvalumab

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2033
Actual
Sample size
Target
121
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Lifehouse - Camperdown
Recruitment hospital [2] 0 0
GenesisCare North Shore - St Leonards
Recruitment hospital [3] 0 0
Westmead Hospital; Medical Oncology and Pallative Care - Westmead
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
Recruitment hospital [5] 0 0
One Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
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Florida
Country [5] 0 0
United States of America
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Michigan
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Oregon
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United States of America
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Pennsylvania
Country [8] 0 0
United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Belgium
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Charleroi
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Belgium
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Gent
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Brazil
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BA
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Brazil
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CE
Country [15] 0 0
Brazil
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MG
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Brazil
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RJ
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Brazil
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RS
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Brazil
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SC
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Brazil
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SP
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Canada
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Ontario
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Chile
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Santiago
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Chile
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Temuco
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China
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Beijing
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China
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Changsha CITY
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China
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Chongqing City
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China
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Jinan
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China
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Nanjing City
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China
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Qingdao City
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China
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Shanghai
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China
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Tianjin
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China
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Wuhan City
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China
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Xi'an
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Colombia
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Barranquilla
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Colombia
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Bogota, D.C.
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Colombia
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Bogota
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Colombia
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Medellin
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Costa Rica
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San José
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France
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Angers
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Caen
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Lyon
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Marseille cedex 20
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Berlin
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Germany
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Chemnitz
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Germany
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Esslingen
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Germany
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Heidelberg
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München
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Haryana
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Israel
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Puglia
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Toscana
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Italy
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Veneto
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Japan
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Aichi
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Aomori
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Chiba
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Ehime
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Fukuoka
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Hyogo
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Kagoshima
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Kanagawa
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Kumamoto
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Miyagi
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Nara
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Niigata
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Okayama
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Osaka-sayama
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Osaka
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Shizuoka
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Tokyo
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Tottori
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Yamaguchi
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Korea, Republic of
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Cheongju-si
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gyeongsangnam-do
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Korea, Republic of
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Jeollanam-do
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Netherlands
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Maastricht
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New Zealand
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Auckland
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Norway
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Oslo
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Poland
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Lublin
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Olsztyn
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Poznan
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Poland
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Warszawa
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Poland
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Wroc?aw
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Sremska Kamenica
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Singapore
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Singapore
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Spain
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LA Coruña
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Spain
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LAS Palmas
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Madrid
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Malaga
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Göteborg
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Sweden
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Stockholm
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Taiwan
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New Taipei City
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Taiwan
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Xitun Dist.
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Thailand
State/province [118] 0 0
Bangkok
Country [119] 0 0
Thailand
State/province [119] 0 0
Dusit
Country [120] 0 0
Thailand
State/province [120] 0 0
Songkhla
Country [121] 0 0
Turkey
State/province [121] 0 0
Adana
Country [122] 0 0
Turkey
State/province [122] 0 0
Ankara
Country [123] 0 0
Turkey
State/province [123] 0 0
Bakirkoy / Istanbul
Country [124] 0 0
Turkey
State/province [124] 0 0
Diyarbakir
Country [125] 0 0
Turkey
State/province [125] 0 0
Erzurum
Country [126] 0 0
Turkey
State/province [126] 0 0
Istanbul
Country [127] 0 0
Turkey
State/province [127] 0 0
Samsun
Country [128] 0 0
Turkey
State/province [128] 0 0
Seyhan
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Birmingham
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Cardiff
Country [131] 0 0
United Kingdom
State/province [131] 0 0
London
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BO42777 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05170204