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Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer (KontRASt-02)

Primary Purpose

Non-Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
JDQ443
docetaxel
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring NSCLC, Non small cell lung cancer, Lung cancer, Cancer of the lung, Cancer of lung, Pulmonary Cancer, Neoplasms, Lung, Neoplasms, Pulmonary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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. 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

Sites / Locations

  • Clinical Research Alliance ResearchRecruiting
  • Valley Medical Center Research Valley Professional Center BldRecruiting
  • Novartis Investigative SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

JDQ443

Docetaxel

Arm Description

Participants will be treated with JDQ443

Participant will be treated with docetaxel following local guidelines as per standard of care and product labels

Outcomes

Primary Outcome Measures

Progression free survival (PFS)
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.

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from date of randomization to date of death due to any cause
Overall Response Rate (ORR)
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)
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)
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)
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)
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
To characterize the pharmacokinetics of JDQ443 and its metabolite HZC320
Time to definitive deterioration of Eastern Cooperative Group of Oncology Group (ECOG) performance status
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
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 10-point deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30
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
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
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
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
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).

Full Information

First Posted
November 11, 2021
Last Updated
October 2, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05132075
Brief 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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
April 21, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study has been designed as a Phase III trial and consists of 2 parts: Randomized part will evaluate the efficacy and safety of JDQ443 as monotherapy in comparison with docetaxel. Participants randomized to docetaxel arm will have the opportunity to cross-over to JDQ443 at disease progression per RECIST 1.1 confirmed by BIRC. Extension part will be open after final progression-free survival (PFS) analysis (if the primary endpoint has met statistical significance) to allow participants randomized to docetaxel treatment to crossover to receive JDQ443 treatment regardless of progression on docetaxel. The study population will include adult participants with locally advanced or metastatic (stage IIIB/IIIC or IV) KRAS G12C mutant non-small cell lung cancer (by tissue or plasma as determined by a Novartis-designated central laboratory or accepted local tests) who have received prior platinum-based chemotherapy and prior immune checkpoint inhibitor therapy administered either in sequence or as combination therapy. Approximately 360 participants will be randomized to JDQ443 or docetaxel in a 1:1 ratio stratified by prior line of therapy and ECOG performance status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
NSCLC, Non small cell lung cancer, Lung cancer, Cancer of the lung, Cancer of lung, Pulmonary Cancer, Neoplasms, Lung, Neoplasms, Pulmonary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JDQ443
Arm Type
Experimental
Arm Description
Participants will be treated with JDQ443
Arm Title
Docetaxel
Arm Type
Active Comparator
Arm Description
Participant will be treated with docetaxel following local guidelines as per standard of care and product labels
Intervention Type
Drug
Intervention Name(s)
JDQ443
Intervention Description
JDQ443 tablets, orally administered
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
docetaxel concentrated solution for infusion, intravenously administered
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
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.
Time Frame
Approximately up to 24 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from date of randomization to date of death due to any cause
Time Frame
Approximately up to 33 months
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
Approximately up to 33 months
Title
Disease Control Rate (DCR)
Description
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 Frame
Approximately up to 33 months
Title
Time To Response (TTR)
Description
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)
Time Frame
Approximately up to 33 months
Title
Duration of Response (DOR)
Description
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.
Time Frame
Approximately up to 33 months
Title
Progression-Free Survival after next line therapy (PFS2)
Description
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.
Time Frame
Approximately up to 33 months
Title
Concentration of JDQ443 and its metabolite in plasma
Description
To characterize the pharmacokinetics of JDQ443 and its metabolite HZC320
Time Frame
Approximately up to 33 months
Title
Time to definitive deterioration of Eastern Cooperative Group of Oncology Group (ECOG) performance status
Description
Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Time Frame
Approximately up to 33 months
Title
Time to definitive 10-point deterioration symptom scores of chest pain, cough and dyspnea per QLQ-LC13
Description
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 Frame
Approximately up to 33 months
Title
Time to definitive 10-point deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30
Description
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
Time Frame
Approximately up to 33 months
Title
Change from baseline in EORTC-QLQ-C30
Description
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.
Time Frame
Approximately up to 33 months
Title
Change from baseline in EORTC-QLQ-LC13
Description
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.
Time Frame
Approximately up to 33 months
Title
Change from baseline in EORTC-EQ-5D-5L
Description
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.
Time Frame
Approximately up to 33 months
Title
Change from baseline in NSCLC-SAQ
Description
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).
Time Frame
Approximately up to 33 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Alliance Research
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krishna Pandit
Phone
+1 516 488 2918#183
Email
kpandit@researchcra.com
First Name & Middle Initial & Last Name & Degree
James D Olimpio
Facility Name
Valley Medical Center Research Valley Professional Center Bld
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Aguilar
Email
Sarah_Aguilar@valleymed.org
First Name & Middle Initial & Last Name & Degree
Navanshu Arora
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1414DRK
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1900AWT
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629AHJ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cordoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01308-050
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rio Grande Do Sul
ZIP/Postal Code
90035-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Russe
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7560908
Country
Chile
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
51000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhe Jiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100036
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
5602310
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Monteria
ZIP/Postal Code
230004
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ostrava Vitkovice
ZIP/Postal Code
703 84
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Odense C
ZIP/Postal Code
DK 5000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Turku
ZIP/Postal Code
FI-20521
Country
Finland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vaasa
ZIP/Postal Code
65130
Country
Finland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Athens
State/Province
GR
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
11526
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Heraklion Crete
ZIP/Postal Code
711 10
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shatin New Territories
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Torokbalint
State/Province
Pest
ZIP/Postal Code
2045
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Reykjavik
ZIP/Postal Code
IS-101
Country
Iceland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422 004
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302019
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700160
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lucca
State/Province
LU
ZIP/Postal Code
55100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Aviano
State/Province
PN
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Amman
ZIP/Postal Code
11941
Country
Jordan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Amman
ZIP/Postal Code
1857
Country
Jordan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Irbid
ZIP/Postal Code
22110
Country
Jordan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seongnam Si
State/Province
Gyeonggi Do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Seocho Gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ashrafieh
ZIP/Postal Code
166830
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beirut
ZIP/Postal Code
1107 2020
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dora
ZIP/Postal Code
90375
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Saida
ZIP/Postal Code
652
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Petaling Jaya
State/Province
Selangor Darul Ehsan
ZIP/Postal Code
46150
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
46050
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cuautitlan Izcalli
State/Province
Estado De Mexico
ZIP/Postal Code
54769
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mexico City
ZIP/Postal Code
06760
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Drammen
ZIP/Postal Code
3004
Country
Norway
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
NO 0450
Country
Norway
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02 781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Matosinhos
ZIP/Postal Code
4454 513
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4100-180
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Alba Iulia
State/Province
Alba
ZIP/Postal Code
510077
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Floresti
State/Province
Cluj
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200347
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cluj Napoca
ZIP/Postal Code
400058
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cluj-Napoca
ZIP/Postal Code
400124
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Constanta
ZIP/Postal Code
905900
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Suceava
ZIP/Postal Code
727525
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Timisoara
ZIP/Postal Code
300425
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cordoba
State/Province
Andalucia
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Badalona
State/Province
Catalunya
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Alicante
State/Province
Comunidad Valenciana
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
La Coruna
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
103616
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Khon Kaen
State/Province
THA
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06680
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cankaya Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Fatih / Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Stoke on Trent
State/Province
Staffordshire
ZIP/Postal Code
ST46QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Staffordshire
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hanoi
ZIP/Postal Code
300000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan 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/.

Learn more about this trial

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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