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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
26/06/2024

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)
Timepoint [1] 0 0
Approximately up to 24 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Approximately up to 33 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
Approximately up to 33 months
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
Approximately up to 33 months
Secondary outcome [4] 0 0
Time To Response (TTR)
Timepoint [4] 0 0
Approximately up to 33 months
Secondary outcome [5] 0 0
Duration of Response (DOR)
Timepoint [5] 0 0
Approximately up to 33 months
Secondary outcome [6] 0 0
Progression-Free Survival after next line therapy (PFS2)
Timepoint [6] 0 0
Approximately up to 33 months
Secondary outcome [7] 0 0
Concentration of JDQ443 and its metabolite in plasma
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
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
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
Timepoint [10] 0 0
Approximately up to 33 months
Secondary outcome [11] 0 0
Change from baseline in EORTC-QLQ-C30
Timepoint [11] 0 0
Approximately up to 33 months
Secondary outcome [12] 0 0
Change from baseline in EORTC-QLQ-LC13
Timepoint [12] 0 0
Approximately up to 33 months
Secondary outcome [13] 0 0
Change from baseline in EORTC-EQ-5D-5L
Timepoint [13] 0 0
Approximately up to 33 months
Secondary outcome [14] 0 0
Change from baseline in NSCLC-SAQ
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
No limit
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
24/05/2025
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 - Hyde Park
Recruitment hospital [3] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [4] 0 0
Novartis Investigative Site - Southport
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4812 - Hyde Park
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4215 - Southport
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
Argentina
State/province [3] 0 0
Cordoba
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Chile
State/province [5] 0 0
Region Metropolitana
Country [6] 0 0
China
State/province [6] 0 0
Anhui
Country [7] 0 0
China
State/province [7] 0 0
Fujian
Country [8] 0 0
China
State/province [8] 0 0
Guangdong
Country [9] 0 0
China
State/province [9] 0 0
Heilongjiang
Country [10] 0 0
China
State/province [10] 0 0
Hubei
Country [11] 0 0
China
State/province [11] 0 0
Hunan
Country [12] 0 0
China
State/province [12] 0 0
Shandong
Country [13] 0 0
China
State/province [13] 0 0
Shengyang
Country [14] 0 0
China
State/province [14] 0 0
Zhe Jiang
Country [15] 0 0
China
State/province [15] 0 0
Beijing
Country [16] 0 0
China
State/province [16] 0 0
Chongqing
Country [17] 0 0
China
State/province [17] 0 0
Zhengzhou
Country [18] 0 0
Colombia
State/province [18] 0 0
Antioquia
Country [19] 0 0
Colombia
State/province [19] 0 0
Cesar
Country [20] 0 0
Colombia
State/province [20] 0 0
Monteria
Country [21] 0 0
Croatia
State/province [21] 0 0
Zagreb
Country [22] 0 0
Finland
State/province [22] 0 0
Turku
Country [23] 0 0
Greece
State/province [23] 0 0
GR
Country [24] 0 0
Greece
State/province [24] 0 0
Athens
Country [25] 0 0
Greece
State/province [25] 0 0
Heraklion Crete
Country [26] 0 0
Greece
State/province [26] 0 0
Thessaloniki
Country [27] 0 0
Hong Kong
State/province [27] 0 0
Hong Kong
Country [28] 0 0
Hong Kong
State/province [28] 0 0
Kowloon
Country [29] 0 0
Hong Kong
State/province [29] 0 0
Shatin New Territories
Country [30] 0 0
Hungary
State/province [30] 0 0
Budapest
Country [31] 0 0
Iceland
State/province [31] 0 0
Reykjavik
Country [32] 0 0
India
State/province [32] 0 0
Andhra Pradesh
Country [33] 0 0
India
State/province [33] 0 0
Andhrapradesh
Country [34] 0 0
India
State/province [34] 0 0
Karnataka
Country [35] 0 0
India
State/province [35] 0 0
Maharashtra
Country [36] 0 0
India
State/province [36] 0 0
Rajasthan
Country [37] 0 0
India
State/province [37] 0 0
West Bengal
Country [38] 0 0
India
State/province [38] 0 0
Delhi
Country [39] 0 0
India
State/province [39] 0 0
Mumbai
Country [40] 0 0
Italy
State/province [40] 0 0
LU
Country [41] 0 0
Italy
State/province [41] 0 0
PN
Country [42] 0 0
Italy
State/province [42] 0 0
RM
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Jordan
State/province [43] 0 0
Amman
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Korea, Republic of
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Gyeonggi Do
Country [45] 0 0
Lebanon
State/province [45] 0 0
Ashrafieh
Country [46] 0 0
Lebanon
State/province [46] 0 0
Dora
Country [47] 0 0
Malaysia
State/province [47] 0 0
Sarawak
Country [48] 0 0
Malaysia
State/province [48] 0 0
Selangor Darul Ehsan
Country [49] 0 0
Malaysia
State/province [49] 0 0
Selangor
Country [50] 0 0
Malaysia
State/province [50] 0 0
Kuala Lumpur
Country [51] 0 0
Mexico
State/province [51] 0 0
Estado De Mexico
Country [52] 0 0
Mexico
State/province [52] 0 0
Jalisco
Country [53] 0 0
Mexico
State/province [53] 0 0
Mexico City
Country [54] 0 0
Mexico
State/province [54] 0 0
Veracruz
Country [55] 0 0
Portugal
State/province [55] 0 0
Matosinhos
Country [56] 0 0
Portugal
State/province [56] 0 0
Porto
Country [57] 0 0
Romania
State/province [57] 0 0
Cluj-Napoca
Country [58] 0 0
Romania
State/province [58] 0 0
Suceava
Country [59] 0 0
Slovenia
State/province [59] 0 0
Ljubljana
Country [60] 0 0
Spain
State/province [60] 0 0
Andalucia
Country [61] 0 0
Spain
State/province [61] 0 0
Asturias
Country [62] 0 0
Spain
State/province [62] 0 0
Navarra
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Taiwan
State/province [64] 0 0
Tainan
Country [65] 0 0
Thailand
State/province [65] 0 0
THA
Country [66] 0 0
Thailand
State/province [66] 0 0
Bangkok
Country [67] 0 0
Turkey
State/province [67] 0 0
Yenimahalle
Country [68] 0 0
Turkey
State/province [68] 0 0
Adana
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Turkey
State/province [69] 0 0
Ankara
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Turkey
State/province [70] 0 0
Antalya
Country [71] 0 0
Turkey
State/province [71] 0 0
Cankaya Ankara
Country [72] 0 0
Turkey
State/province [72] 0 0
Fatih-Istanbul
Country [73] 0 0
Turkey
State/province [73] 0 0
Fatih
Country [74] 0 0
Turkey
State/province [74] 0 0
Istanbul
Country [75] 0 0
Turkey
State/province [75] 0 0
Sakarya
Country [76] 0 0
Vietnam
State/province [76] 0 0
Hanoi

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05132075
Trial related presentations / publications
Public notes

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