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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06497556
Registration number
NCT06497556
Ethics application status
Date submitted
5/07/2024
Date registered
11/07/2024
Date last updated
4/07/2025
Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer
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Scientific title
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer
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Secondary ID [1]
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2024-510908-37-00
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Secondary ID [2]
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BO45217
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Universal Trial Number (UTN)
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Trial acronym
Krascendo 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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KRAS G12C Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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0
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Lung - Non small cell
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Cancer
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0
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Divarasib
Treatment: Drugs - Sotorasib
Treatment: Drugs - Adagrasib
Experimental: Divarasib - Participants will receive divarasib orally, once daily (QD).
Active comparator: KRAS G12C inhibitor - Participants will receive Sotorasib orally QD or adagrasib orally twice a day (BID)
Treatment: Drugs: Divarasib
Divarasib will be administered orally QD
Treatment: Drugs: Sotorasib
Sotorasib will be administered orally QD
Treatment: Drugs: Adagrasib
Adagrasib will be administred orally BID
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause (whichever occurs first)
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Timepoint [1]
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Up to approximately 4 years
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from randomization to death from any cause
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Timepoint [1]
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Up to approximately 4 years
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Secondary outcome [2]
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Objective Response
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Assessment method [2]
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Objective response is defined as complete response (CR) or partial response (PR) as determined by BICR according to RECIST v1.1
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Timepoint [2]
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Up to approximately 4 years
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Secondary outcome [3]
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Time to Confirmed Deterioration (TTCD) on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Dyspnea Item and Physical Functioning Scale
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Assessment method [3]
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Timepoint [3]
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Baseline up to approximately 4 years
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Secondary outcome [4]
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TTCD on the EORTC Quality-of-Life Questionnaire-Supplemental Lung Cancer Module (QLQ-LC13) Cough Scale
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Assessment method [4]
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Timepoint [4]
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Baseline up to approximately 4 years
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Secondary outcome [5]
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Duration of Response (DOR)
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Assessment method [5]
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DOR is defined as the time from the first occurrence of a documented objective response to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause (whichever occurs first)
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Timepoint [5]
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Up to approximately 4 years
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Secondary outcome [6]
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Percentage of Participants with Adverse Events (AEs)
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Assessment method [6]
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Timepoint [6]
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Up to approximately 4 years
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Secondary outcome [7]
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Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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Assessment method [7]
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Timepoint [7]
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Up to approximately 4 years
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Secondary outcome [8]
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Change from Baseline in Diarrhea, Nausea, Vomiting, Anorexia, Alopecia, Dyspnea, Cough, Constipation, Myalgia, Headache, and Rash/Acne as Assessed Through use of the NCI PRO-CTCAE
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Assessment method [8]
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Timepoint [8]
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Baseline up to approximately 4 years
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Secondary outcome [9]
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Frequency of Participants' Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the single-item EORTC Item List (IL46)
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Assessment method [9]
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Timepoint [9]
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Up to approximately 4 years
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Secondary outcome [10]
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Change from Baseline in Cough, Chest Pain, Dyspnea, Physical and Role Functioning, and Global Health Status score/Quality of Life Score (GHS/QoL) at Each Timepoint as Assessed Through use of the EORTC QLQ-LC13 and QLQ-C30
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Assessment method [10]
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Timepoint [10]
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Baseline up to approximately 4 years
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Secondary outcome [11]
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TTCD on the EORTC QLQ-C30 Role Functioning and GHS/QoL scales
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Assessment method [11]
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0
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Timepoint [11]
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Up to approximately 4 years
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Secondary outcome [12]
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TTCD on the Chest Pain Scale of the QLQ-LC13 Scales
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Assessment method [12]
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Timepoint [12]
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Up to approximately 4 years
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Eligibility
Key inclusion criteria
* Unequivocal histologically or cytologically confirmed diagnosis of metastatic or locally advanced NSCLC not amenable to treatment with surgical resection or combined chemoradiation
* Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Documentation of the presence of a KRAS G12C mutation
* Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of >= 12 weeks
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* Known concomitant second oncogenic driver
* Mixed small-cell lung cancer or large cell neuroendocrine histology
* Known and untreated, or active central nervous system (CNS) metastases
* Leptomeningeal disease or carcinomatous meningitis
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently
* Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1
* Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor
* More than 30 Gy of radiotherapy to the lung within 6 months of randomization
* Uncontrolled tumor-related pain
* Unresolved toxicities from prior anticancer therapy
* History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and 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, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/09/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2029
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Actual
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Sample size
Target
320
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Kinghorn Cancer Centre - Darlinghurst
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Liverpool Hospital - Liverpool
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GenesisCare North Shore - St Leonards
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Sunshine Coast University Hospital - Birtinya
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [6]
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Peter Maccallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2170 - Liverpool
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2065 - St Leonards
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Recruitment postcode(s) [4]
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4575 - Birtinya
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Recruitment postcode(s) [5]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [6]
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3000 - Melbourne
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Recruitment outside Australia
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Ehime
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Country [108]
0
0
Japan
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State/province [108]
0
0
Fukuoka
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Country [109]
0
0
Japan
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State/province [109]
0
0
Hokkaido
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Country [110]
0
0
Japan
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State/province [110]
0
0
Miyagi
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Country [111]
0
0
Japan
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State/province [111]
0
0
Niigata
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Country [112]
0
0
Japan
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State/province [112]
0
0
Okayama
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Country [113]
0
0
Japan
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State/province [113]
0
0
Osaka
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Country [114]
0
0
Japan
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State/province [114]
0
0
Shizuoka
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Country [115]
0
0
Japan
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State/province [115]
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0
Tokyo
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Country [116]
0
0
Japan
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State/province [116]
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0
Wakayama
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Country [117]
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0
Korea, Republic of
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State/province [117]
0
0
Busan
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Country [118]
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0
Korea, Republic of
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State/province [118]
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0
Cheongju-si
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Country [119]
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0
Korea, Republic of
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State/province [119]
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0
Daegu
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Country [120]
0
0
Korea, Republic of
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State/province [120]
0
0
Gyeonggi-do
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Country [121]
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0
Korea, Republic of
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State/province [121]
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0
Gyeongsangnam-do
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Country [122]
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0
Korea, Republic of
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State/province [122]
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0
Incheon
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Country [123]
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Korea, Republic of
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State/province [123]
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0
Jeollanam-do
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Country [124]
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0
Korea, Republic of
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State/province [124]
0
0
Seongnam-si
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Country [125]
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0
Korea, Republic of
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State/province [125]
0
0
Seoul
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Country [126]
0
0
Mexico
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State/province [126]
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0
Coahuila
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Country [127]
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0
Mexico
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State/province [127]
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0
Jalisco
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Country [128]
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0
Mexico
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State/province [128]
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Puebla
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Country [129]
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0
Mexico
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State/province [129]
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Queretaro
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0
Mexico
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State/province [130]
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Ciudad de México
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Country [131]
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0
Netherlands
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State/province [131]
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0
'S Hertogenbosch
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Country [132]
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0
Netherlands
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State/province [132]
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Arnhem
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Country [133]
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0
Netherlands
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State/province [133]
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0
Breda
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Country [134]
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0
Netherlands
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State/province [134]
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0
Harderwijk
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Country [135]
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0
Netherlands
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State/province [135]
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0
Leidschendam
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Country [136]
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0
Netherlands
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State/province [136]
0
0
Zwolle
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Country [137]
0
0
Poland
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State/province [137]
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0
?ód?
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Country [138]
0
0
Poland
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State/province [138]
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0
Bydgoszcz
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Country [139]
0
0
Poland
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State/province [139]
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0
Gdansk
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Country [140]
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0
Poland
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State/province [140]
0
0
Kraków
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Country [141]
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0
Poland
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State/province [141]
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Lublin
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Country [142]
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0
Poland
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State/province [142]
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0
Olsztyn
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Country [143]
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0
Poland
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State/province [143]
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0
Poznan
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Country [144]
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0
Poland
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State/province [144]
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0
Radom
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Country [145]
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0
Poland
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State/province [145]
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0
Warszawa
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Country [146]
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0
Poland
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State/province [146]
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0
Wroc?aw
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Country [147]
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0
Portugal
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State/province [147]
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Braga
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Country [148]
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0
Portugal
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State/province [148]
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0
Coimbra
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Country [149]
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0
Portugal
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State/province [149]
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0
Lisboa
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Country [150]
0
0
Portugal
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State/province [150]
0
0
Porto
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Country [151]
0
0
Singapore
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State/province [151]
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0
Singapore
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Country [152]
0
0
Spain
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State/province [152]
0
0
Barcelona
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Country [153]
0
0
Spain
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State/province [153]
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0
Sevilla
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Country [154]
0
0
Spain
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State/province [154]
0
0
Madrid
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Country [155]
0
0
Spain
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State/province [155]
0
0
Malaga
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Country [156]
0
0
Spain
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State/province [156]
0
0
Valencia
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Country [157]
0
0
Spain
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State/province [157]
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0
Zaragoza
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Country [158]
0
0
Sweden
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State/province [158]
0
0
Gävle
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Country [159]
0
0
Taiwan
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State/province [159]
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0
Hsinchu City
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Country [160]
0
0
Taiwan
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State/province [160]
0
0
Kaohsiung
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Country [161]
0
0
Taiwan
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State/province [161]
0
0
Taichung
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Country [162]
0
0
Taiwan
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State/province [162]
0
0
Taipei
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Country [163]
0
0
Taiwan
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State/province [163]
0
0
Taoyuan
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Country [164]
0
0
Thailand
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State/province [164]
0
0
Bangkok
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Country [165]
0
0
Thailand
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State/province [165]
0
0
Khon Kaen
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Country [166]
0
0
Thailand
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State/province [166]
0
0
Songkhla
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Country [167]
0
0
United Kingdom
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State/province [167]
0
0
Blackpool
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Country [168]
0
0
United Kingdom
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State/province [168]
0
0
Cambridge
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Country [169]
0
0
United Kingdom
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State/province [169]
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0
Cardiff
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Country [170]
0
0
United Kingdom
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State/province [170]
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0
Cottingham
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Country [171]
0
0
United Kingdom
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State/province [171]
0
0
Glasgow
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Country [172]
0
0
United Kingdom
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State/province [172]
0
0
Leeds
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Country [173]
0
0
United Kingdom
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State/province [173]
0
0
London
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Country [174]
0
0
United Kingdom
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State/province [174]
0
0
Manchester
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Country [175]
0
0
United Kingdom
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State/province [175]
0
0
Nottingham
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Country [176]
0
0
United Kingdom
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State/province [176]
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0
Stoke-On-Trent
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Country [177]
0
0
United Kingdom
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State/province [177]
0
0
Sutton
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Country [178]
0
0
United Kingdom
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State/province [178]
0
0
Torquay
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
Chugai Pharmaceutical
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Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).
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Trial website
https://clinicaltrials.gov/study/NCT06497556
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Clinical Trials
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Address
0
0
Hoffmann-La Roche
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Reference Study ID Number: BO45217 https://forpatients.roche.com/
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Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
888-662-6728 (U.S. and Canada)
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Fax
0
0
Query!
Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
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/NCT06497556
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