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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
Date last updated
3/06/2025

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
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
Secondary ID [1] 0 0
2021-002605-10
Secondary ID [2] 0 0
CJDQ443B12301
Universal Trial Number (UTN)
Trial acronym
KontRASt-02
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 - 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival (PFS)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Approximately up to 24 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Assessment method [1] 0 0
OS is defined as the time from date of randomization to date of death due to any cause
Timepoint [1] 0 0
Approximately up to 33 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Approximately up to 33 months
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Approximately up to 33 months
Secondary outcome [4] 0 0
Time To Response (TTR)
Assessment method [4] 0 0
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)
Timepoint [4] 0 0
Approximately up to 33 months
Secondary outcome [5] 0 0
Duration of Response (DOR)
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Approximately up to 33 months
Secondary outcome [6] 0 0
Progression-Free Survival after next line therapy (PFS2)
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Approximately up to 33 months
Secondary outcome [7] 0 0
Concentration of JDQ443 and its metabolite in plasma
Assessment method [7] 0 0
To characterize the pharmacokinetics of JDQ443 and its metabolite HZC320
Timepoint [7] 0 0
Approximately up to 33 months
Secondary outcome [8] 0 0
Time to definitive deterioration of Eastern Cooperative Group of Oncology Group (ECOG) performance status
Assessment method [8] 0 0
Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Timepoint [8] 0 0
Approximately up to 33 months
Secondary outcome [9] 0 0
Time to definitive 10-point deterioration symptom scores of chest pain, cough and dyspnea per QLQ-LC13
Assessment method [9] 0 0
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
Timepoint [9] 0 0
Approximately up to 33 months
Secondary outcome [10] 0 0
Time to definitive 10-point deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30
Assessment method [10] 0 0
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
Timepoint [10] 0 0
Approximately up to 33 months
Secondary outcome [11] 0 0
Change from baseline in EORTC-QLQ-C30
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
Approximately up to 33 months
Secondary outcome [12] 0 0
Change from baseline in EORTC-QLQ-LC13
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
Approximately up to 33 months
Secondary outcome [13] 0 0
Change from baseline in EORTC-EQ-5D-5L
Assessment method [13] 0 0
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.
Timepoint [13] 0 0
Approximately up to 33 months
Secondary outcome [14] 0 0
Change from baseline in NSCLC-SAQ
Assessment method [14] 0 0
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).
Timepoint [14] 0 0
Approximately up to 33 months

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.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/03/2026
Actual
Sample size
Target
Accrual to date
Final
95
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Novartis Investigative Site - Auchenflower
Recruitment hospital [2] 0 0
Novartis Investigative Site - South Brisbane
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Washington
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
China
State/province [4] 0 0
Fujian
Country [5] 0 0
China
State/province [5] 0 0
Guangdong
Country [6] 0 0
China
State/province [6] 0 0
Heilongjiang
Country [7] 0 0
China
State/province [7] 0 0
Hunan
Country [8] 0 0
China
State/province [8] 0 0
Liaoning
Country [9] 0 0
China
State/province [9] 0 0
Shandong
Country [10] 0 0
China
State/province [10] 0 0
Zhejiang
Country [11] 0 0
China
State/province [11] 0 0
Beijing
Country [12] 0 0
China
State/province [12] 0 0
Chongqing
Country [13] 0 0
Finland
State/province [13] 0 0
Turku
Country [14] 0 0
Greece
State/province [14] 0 0
GR
Country [15] 0 0
Greece
State/province [15] 0 0
Athens
Country [16] 0 0
Greece
State/province [16] 0 0
Heraklion Crete
Country [17] 0 0
Hong Kong
State/province [17] 0 0
Hong Kong
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Kowloon
Country [19] 0 0
Hungary
State/province [19] 0 0
Budapest
Country [20] 0 0
Iceland
State/province [20] 0 0
Reykjavik
Country [21] 0 0
India
State/province [21] 0 0
Rajasthan
Country [22] 0 0
India
State/province [22] 0 0
Delhi
Country [23] 0 0
Italy
State/province [23] 0 0
LU
Country [24] 0 0
Italy
State/province [24] 0 0
PN
Country [25] 0 0
Italy
State/province [25] 0 0
RM
Country [26] 0 0
Jordan
State/province [26] 0 0
Amman
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Gyeonggi Do
Country [28] 0 0
Lebanon
State/province [28] 0 0
Dora
Country [29] 0 0
Malaysia
State/province [29] 0 0
Sarawak
Country [30] 0 0
Malaysia
State/province [30] 0 0
Kuala Lumpur
Country [31] 0 0
Mexico
State/province [31] 0 0
Mexico City
Country [32] 0 0
Portugal
State/province [32] 0 0
Matosinhos
Country [33] 0 0
Portugal
State/province [33] 0 0
Porto
Country [34] 0 0
Romania
State/province [34] 0 0
Cluj-Napoca
Country [35] 0 0
Slovenia
State/province [35] 0 0
Golnik
Country [36] 0 0
Slovenia
State/province [36] 0 0
Ljubljana
Country [37] 0 0
Spain
State/province [37] 0 0
Andalucia
Country [38] 0 0
Spain
State/province [38] 0 0
Asturias
Country [39] 0 0
Spain
State/province [39] 0 0
Navarra
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Taiwan
State/province [41] 0 0
Tainan
Country [42] 0 0
Thailand
State/province [42] 0 0
Bangkok
Country [43] 0 0
Turkey
State/province [43] 0 0
Adana
Country [44] 0 0
Turkey
State/province [44] 0 0
Ankara
Country [45] 0 0
Turkey
State/province [45] 0 0
Cankaya Ankara
Country [46] 0 0
Turkey
State/province [46] 0 0
Fatih-Istanbul
Country [47] 0 0
Turkey
State/province [47] 0 0
Pendik Istanbul
Country [48] 0 0
Vietnam
State/province [48] 0 0
Hanoi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
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/NCT05132075