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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05132075
Registration number
NCT05132075
Ethics application status
Date submitted
11/11/2021
Date registered
24/11/2021
Titles & IDs
Public title
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
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Scientific title
A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
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Secondary ID [1]
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2021-002605-10
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Secondary ID [2]
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CJDQ443B12301
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Universal Trial Number (UTN)
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Trial acronym
KontRASt-02
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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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Condition category
Condition code
Cancer
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0
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Lung - Mesothelioma
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Cancer
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0
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0
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Lung - Non small cell
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Cancer
0
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 - JDQ443
Treatment: Drugs - docetaxel
Experimental: JDQ443 - Participants will be treated with JDQ443
Active comparator: Docetaxel - Participant will be treated with docetaxel following local guidelines as per standard of care and product labels
Treatment: Drugs: JDQ443
JDQ443 tablets, orally administered
Treatment: Drugs: docetaxel
docetaxel concentrated solution for infusion, intravenously administered
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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 the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is based on central assessment and using RECIST 1.1 criteria.
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Timepoint [1]
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Approximately up to 24 months
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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 date of randomization to date of death due to any cause
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Timepoint [1]
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Approximately up to 33 months
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Secondary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on central and local investigator's assessment according to RECIST 1.1.
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Timepoint [2]
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Approximately up to 33 months
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Secondary outcome [3]
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Disease Control Rate (DCR)
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Assessment method [3]
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DCR is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Non-CR/Non-PD.
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Timepoint [3]
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Approximately up to 33 months
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Secondary outcome [4]
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Time To Response (TTR)
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Assessment method [4]
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TTR is defined as the time from the date of randomization to the date of first documented response (CR or PR, which must be confirmed subsequently)
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Timepoint [4]
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Approximately up to 33 months
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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 calculated as the time from the date of first documented response (complete response (CR) or partial response (PR)) to the first documented date of progression or death due to underlying cancer.
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Timepoint [5]
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Approximately up to 33 months
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Secondary outcome [6]
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Progression-Free Survival after next line therapy (PFS2)
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Assessment method [6]
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PFS2 (based on local investigator assessment) is defined as time from date of randomization to the first documented progression on next line therapy or death from any cause, whichever occurs first.
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Timepoint [6]
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Approximately up to 33 months
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Secondary outcome [7]
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Concentration of JDQ443 and its metabolite in plasma
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Assessment method [7]
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To characterize the pharmacokinetics of JDQ443 and its metabolite HZC320
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Timepoint [7]
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Approximately up to 33 months
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Secondary outcome [8]
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Time to definitive deterioration of Eastern Cooperative Group of Oncology Group (ECOG) performance status
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Assessment method [8]
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Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
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Timepoint [8]
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Approximately up to 33 months
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Secondary outcome [9]
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Time to definitive 10-point deterioration symptom scores of chest pain, cough and dyspnea per QLQ-LC13
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Assessment method [9]
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The EORTC QLQ LC13 is a 13-item, lung cancer specific questionnaire module, and it comprises both multi-item and single-item measures of lung cancer-associated symptoms (i.e. coughing, hemoptysis, dyspnea and pain) and side-effects from conventional chemo- and radiotherapy (i.e. hair loss, neuropathy, sore mouth and dysphagia). The time to definitive 10-point deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points absolute increase from baseline (worsening), with no later change below the threshold or death due to any cause
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Timepoint [9]
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Approximately up to 33 months
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Secondary outcome [10]
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Time to definitive 10-point deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30
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Assessment method [10]
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The EORTC QLQ-C30 is a questionnaire developed to assess the health-related quality of life of cancer participants. The questionnaire contains 30 items and is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/HRQoL scale. The time to definitive 10-point deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points absolute increase from baseline (worsening) of the corresponding scale score, with no later change below the threshold or death due to any cause
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Timepoint [10]
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Approximately up to 33 months
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Secondary outcome [11]
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Change from baseline in EORTC-QLQ-C30
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Assessment method [11]
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The EORTC QLQ-C30 is a questionnaire developed to assess the health-related quality of life of cancer participants. The questionnaire contains 30 items and is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/HRQoL scale. A higher score indicates a higher presence of symptoms.
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Timepoint [11]
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Approximately up to 33 months
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Secondary outcome [12]
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Change from baseline in EORTC-QLQ-LC13
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Assessment method [12]
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The EORTC QLQ LC13 is a 13-item, lung cancer specific questionnaire module, and it comprises both multi-item and single-item measures of lung cancer-associated symptoms (i.e. coughing, hemoptysis, dyspnea and pain) and side-effects from conventional chemo- and radiotherapy (i.e. hair loss, neuropathy, sore mouth and dysphagia). A higher score indicates a higher presence of symptoms.
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Timepoint [12]
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Approximately up to 33 months
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Secondary outcome [13]
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Change from baseline in EORTC-EQ-5D-5L
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Assessment method [13]
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The EQ-5D-5L is a generic instrument for describing and valuing health. It is based on a descriptive system that defines health in terms of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.
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Timepoint [13]
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0
Approximately up to 33 months
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Secondary outcome [14]
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Change from baseline in NSCLC-SAQ
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Assessment method [14]
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The Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) is a 7-item, patient-reported outcome measure which assess patient-reported symptoms associated with advanced NSCLC. It contains five domains and accompanying items that were identified as symptoms of NSCLC: cough (1 item), pain (2 items), dyspnea (1 item), fatigue (2 items), and appetite (1 item).
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Timepoint [14]
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Approximately up to 33 months
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Eligibility
Key inclusion criteria
* Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
* Participant has a KRAS G12C mutation present in tumor tissue or plasma prior to enrollment, as determined by a Novartis designated central laboratory or by accepted local tests.
* Participants has received one prior platinum-based chemotherapy regimen and one prior immune checkpoint inhibitor therapy for locally advanced or metastatic disease
* Participant has at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 at the screening visit.
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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
* Participants who have previously received docetaxel (except if received in neoadjuvant or adjuvant setting with no progression within 12 months after the of end of treatment), or any other KRAS G12C inhibitor.
* Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other druggable alterations will be excluded if required by local guidelines.
* Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Participant has an history of interstitial lung disease or pneumonitis grade > 1.
Other inclusion/exclusion criteria may apply
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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
Active, not 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
15/06/2022
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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
24/05/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
95
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Novartis Investigative Site - Auchenflower
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Recruitment hospital [2]
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Novartis Investigative Site - South Brisbane
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Recruitment postcode(s) [1]
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4066 - Auchenflower
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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Washington
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Country [2]
0
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Argentina
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State/province [2]
0
0
Buenos Aires
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Country [3]
0
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Argentina
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State/province [3]
0
0
Cordoba
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Country [4]
0
0
Canada
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State/province [4]
0
0
Quebec
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Country [5]
0
0
Chile
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State/province [5]
0
0
Region Metropolitana
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Country [6]
0
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China
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State/province [6]
0
0
Fujian
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Country [7]
0
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China
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State/province [7]
0
0
Guangdong
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Country [8]
0
0
China
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State/province [8]
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Heilongjiang
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Country [9]
0
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China
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State/province [9]
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Hunan
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Country [10]
0
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China
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State/province [10]
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Shandong
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Country [11]
0
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China
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State/province [11]
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Shengyang
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Country [12]
0
0
China
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State/province [12]
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Zhe Jiang
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Country [13]
0
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China
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State/province [13]
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Beijing
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Country [14]
0
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China
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State/province [14]
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Chongqing
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Country [15]
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Colombia
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State/province [15]
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Antioquia
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Country [16]
0
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Colombia
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State/province [16]
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Cesar
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Country [17]
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Colombia
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State/province [17]
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Monteria
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Country [18]
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Finland
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State/province [18]
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Turku
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Greece
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GR
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Country [20]
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Greece
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Athens
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Greece
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Heraklion Crete
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Hong Kong
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Hong Kong
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Hong Kong
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Kowloon
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Hong Kong
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Shatin New Territories
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Hungary
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Budapest
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Iceland
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Reykjavik
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India
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Rajasthan
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Country [28]
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India
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State/province [28]
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Delhi
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Country [29]
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Italy
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LU
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Italy
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PN
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Country [31]
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Italy
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State/province [31]
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RM
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Country [32]
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Jordan
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Amman
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Korea, Republic of
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Gyeonggi Do
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Lebanon
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Ashrafieh
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Lebanon
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Dora
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Malaysia
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Sarawak
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Malaysia
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Kuala Lumpur
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Mexico
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Estado De Mexico
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Mexico
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Jalisco
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Mexico
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Mexico City
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Mexico
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Veracruz
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Portugal
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Matosinhos
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Portugal
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Porto
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Romania
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Cluj-Napoca
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Slovenia
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Golnik
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Slovenia
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Ljubljana
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Spain
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Andalucia
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Spain
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Asturias
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Spain
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Navarra
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Spain
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Madrid
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Taiwan
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Tainan
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Thailand
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THA
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Thailand
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Bangkok
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Turkey
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Yenimahalle
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Cankaya Ankara
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Turkey
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Fatih-Istanbul
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Turkey
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Fatih
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Turkey
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Istanbul
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Vietnam
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Hanoi
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a phase III randomized open label study designed to compare JDQ443 as monotherapy to docetaxel in participants with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously treated with a platinum-based chemotherapy and immune checkpoint inhibitor therapy either in sequence or in combination.
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Trial website
https://clinicaltrials.gov/study/NCT05132075
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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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
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Address
0
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Phone
0
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Fax
0
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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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/NCT05132075