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Trial details
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
Current status:
Approved
|
Date registered:
03/06/2022
Trial version(s)
History: 28/03/2022
History: 28/03/2022
History: 28/03/2022
History: 28/03/2022
History: 28/03/2022
History: 28/03/2022
History: 28/03/2022
History: 28/03/2022
History: 28/03/2022
History: 28/03/2022
History: 28/03/2022
History: 28/03/2022
History: 28/03/2022
History: 28/03/2022
History: 28/03/2022
Current: 28/03/2022
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Main Information
Primary registry identifying number
LBCTR2022055019
Protocol number
CJDQ443B12301
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharmaceuticals
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
Acronym
KontRASt-02
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
Acronym
KontRASt-02
Brief summary of the study: English
This is a phase III 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.
Brief summary of the study: Arabic
دراسة مرحلة ثالثة ومفتوحة التسمية تقيّم فعاليّة وسلامة دواء JDQ443 مقابل دوسيتاكسيل لدى أشخاص معالجين سابقًا مصابين بسرطان الرئة ذي الخلايا غير الصغيرة المتقدّم محليًا أو المنتشر مع الطفرة الجينيّة KRAS G12C
Health conditions/problem studied: Specify
Non-Small Cell Lung Cancer
Interventions: Specify
Drug: JDQ443 JDQ443 tablets, orally administered Drug: docetaxel docetaxel concentrated solution for infusion, intravenously administered
Key inclusion and exclusion criteria: Inclusion criteria
- Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV) - Participant has a KRAS G12C mutation present in tumor tissue prior to enrollment, as determined by a Novartis designated central laboratory. - 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.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
- Participant has previously received docetaxel, KRAS G12C inhibitor or any other systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior immune check point inhibitor - Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing - 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.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
JDQ443
Type of IMP
Gene therapy
Pharmaceutical class
KRAS G12C inhibitors
Therapeutic indication
Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
Therapeutic benefit
To determine if JDQ443 is safe and effective for better controlling NSCLC, with KRAS G12C mutation, compared to docetaxel
Biospecimen retention
Samples with DNA**
Biospecimen description
Samples will be shipped to Q2 for lab tests and Navigate biopharma for biomarker assessment
Target sample size
6
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
27/06/2022
Date of study closure: Type
Anticipated
Date of study closure: Date
29/05/2025
Recruitment status
Pending
Date of completion
IPD sharing statement plan
Yes
IPD sharing statement description
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/.
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT05132075?term=CJDQ443B12301&draw=2&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
clinicaltrials.gov
NCT05132075
Sources of Monetary or Material Support
Name
Novartis Pharmaceuticals
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Fadi
Farhat
Saida
Lebanon
+961 3 753155
drfadi.trials@gmail.com
Hammoud Hospital University Medical Center
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
01512002 ext. 271
hind.khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hammoud Hospital University Medical Center
Fadi Farhat
Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hammoud Hospital University Medical Center
28/01/2022
Ibrahim Omeis
iomeis@hammoudhospital.org
+961 (0) 7 723111 ext 1222/1223
Countries of Recruitment
Name
Czech Republic
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer
Malignant neoplasm of bronchus and lung (C34)
non-small cell lung cancer
Interventions
Intervention
Description
Keyword
IMP administration , ICF, visit assessment and schedule
IMP administration , ICF, visit assessment and schedule
IMP administration , ICF, visit assessment and schedule
Primary Outcomes
Name
Time points
Measure
Progression free survival (PFS)
Approximately up to 24 months
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
Key Secondary Outcomes
Name
Time points
Measure
Overall Survival (OS)
Approximately up to 33 months
OS is defined as the time from date of randomization to date of death due to any cause
Overall Response Rate (ORR)
Approximately up to 33 months
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.
Disease Control Rate (DCR)
Approximately up to 33 months
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.
Time To Response (TTR)
Approximately up to 33 months
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)
Duration of Response (DOR)
Approximately up to 33 months
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.
Progression-Free Survival after next line therapy (PFS2)
Approximately up to 33 months
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.
Concentration of JDQ443 and its metabolite in plasma
Approximately up to 33 months
To characterize the pharmacokinetics of JDQ443 and its metabolite HZC320
Time to definitive deterioration of Eastern Cooperative Group of Oncology Group (ECOG) performance status
Approximately up to 33 months
Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Time to definitive 10-point deterioration symptom scores of chest pain, cough and dyspnea per QLQ-LC13
Approximately up to 33 months
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
Time to definitive deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30
Approximately up to 33 months
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
Change from baseline in EORTC-QLQ-C30
Approximately up to 33 months
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.
Change from baseline in EORTC-QLQ-LC13
Approximately up to 33 months
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.
Change from baseline in EORTC-EQ-5D-5L
Approximately up to 33 months
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.
Change from baseline in NSCLC-SAQ
Approximately up to 33 months
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).
PFS based on KRAS G12C mutation status in plasma.
Approximately up to 33 months
To compare the clinical outcomes for JDQ443 vs docetaxel based on KRAS G12C mutation status in plasma
OS based on KRAS G12C mutation status in plasma.
Approximately up to 33 months
To compare the clinical outcomes for JDQ443 vs docetaxel based on KRAS G12C mutation status in plasma
ORR based on KRAS G12C mutation status in plasma
Approximately up to 33 months
To compare the clinical outcomes for JDQ443 vs docetaxel based on KRAS G12C mutation status in plasma
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Initial submission
06/05/2022
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