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

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

ClinicalTrials.gov Identifier: NCT05132075

Novartis Reference Number: CJDQ443B12301

Last Update: Mar 31, 2023

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Non-Small Cell Lung Cancer
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Jun 15, 2022
Completion date 
May 29, 2025
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
JDQ443
JDQ443 tablets, orally administered
Drug
docetaxel
docetaxel concentrated solution for infusion, intravenously administered

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 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

Study Locations

Argentina
Novartis Investigative Site
Recruiting
Caba, C1414DRK
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Pilar, B1629AHJ
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, C1431FWO
-
Argentina
Novartis Investigative Site
Recruiting
Cordoba, X5000JHQ
-
Argentina
Bulgaria
Novartis Investigative Site
Recruiting
Plovdiv, 4004
-
Bulgaria
Novartis Investigative Site
Recruiting
Russe, 7002
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1303
-
Bulgaria
Croatia
Novartis Investigative Site
Recruiting
Zagreb, 10000
-
Croatia
Czech Republic
Novartis Investigative Site
Recruiting
Ostrava Vitkovice, 703 84
-
Czech Republic
Estonia
Novartis Investigative Site
Recruiting
Tartu, 50406
-
Estonia
Finland
Novartis Investigative Site
Recruiting
Turku, FI-20521
-
Finland
Novartis Investigative Site
Recruiting
Vaasa, 65130
-
Finland
Greece
Novartis Investigative Site
Recruiting
Athens, 11526
-
Greece
Hong Kong
Novartis Investigative Site
Recruiting
Hong Kong, 999077
-
Hong Kong
Novartis Investigative Site
Recruiting
Shatin New Territories,
-
Hong Kong
Hungary
Novartis Investigative Site
Recruiting
Torokbalint, 2045
Pest
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1121
-
Hungary
Iceland
Novartis Investigative Site
Recruiting
Reykjavik, IS-101
-
Iceland
Italy
Novartis Investigative Site
Recruiting
Lucca, 55100
LU
Italy
Novartis Investigative Site
Recruiting
Roma, 00128
RM
Italy
Jordan
Novartis Investigative Site
Recruiting
Amman, 11941
-
Jordan
Novartis Investigative Site
Recruiting
Irbid, 22110
-
Jordan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seongnam Si, 13620
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 08308
Korea
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 06591
Seocho Gu
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 05505
-
Korea, Republic of
Lebanon
Novartis Investigative Site
Recruiting
Ashrafieh, 166830
-
Lebanon
Novartis Investigative Site
Recruiting
Dora, 90375
-
Lebanon
Novartis Investigative Site
Recruiting
Saida, 652
-
Lebanon
Malaysia
Novartis Investigative Site
Recruiting
Kuching, 93586
Sarawak
Malaysia
Novartis Investigative Site
Recruiting
Petaling Jaya, 46150
Selangor Darul Ehsan
Malaysia
Novartis Investigative Site
Recruiting
Petaling Jaya, 46050
Selangor
Malaysia
Novartis Investigative Site
Recruiting
Kuala Lumpur, 59100
-
Malaysia
Norway
Novartis Investigative Site
Recruiting
Drammen, 3004
-
Norway
Novartis Investigative Site
Recruiting
Oslo, NO 0450
-
Norway
Novartis Investigative Site
Recruiting
Trondheim, 7006
-
Norway
Portugal
Novartis Investigative Site
Recruiting
Lisboa, 1998-018
-
Portugal
Novartis Investigative Site
Recruiting
Matosinhos, 4454 513
-
Portugal
Novartis Investigative Site
Recruiting
Porto, 4100-180
-
Portugal
Romania
Novartis Investigative Site
Recruiting
Alba Iulia, 510077
Alba
Romania
Novartis Investigative Site
Recruiting
Floresti, 407280
Cluj
Romania
Novartis Investigative Site
Recruiting
Bucharest, 022328
-
Romania
Novartis Investigative Site
Recruiting
Cluj Napoca, 400058
-
Romania
Novartis Investigative Site
Recruiting
Cluj-Napoca, 400124
-
Romania
Novartis Investigative Site
Recruiting
Iasi, 700483
-
Romania
Novartis Investigative Site
Recruiting
Suceava, 727525
-
Romania
Novartis Investigative Site
Recruiting
Timisoara, 300425
-
Romania
Slovenia
Novartis Investigative Site
Recruiting
Golnik, 4204
-
Slovenia
Novartis Investigative Site
Recruiting
Ljubljana, 1000
-
Slovenia
Spain
Novartis Investigative Site
Recruiting
Cordoba, 14004
Andalucia
Spain
Novartis Investigative Site
Recruiting
Oviedo, 33011
Asturias
Spain
Novartis Investigative Site
Recruiting
Alicante, 03010
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
La Coruna, 15006
Galicia
Spain
Novartis Investigative Site
Recruiting
Pamplona, 31008
Navarra
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Taipei,
-
Taiwan
Novartis Investigative Site
Recruiting
Taoyuan, 33305
-
Taiwan
Thailand
Novartis Investigative Site
Recruiting
Khon Kaen, 40002
THA
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10110
-
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10330
-
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10700
-
Thailand
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06560
-
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06680
-
Turkey
Novartis Investigative Site
Recruiting
Cankaya Ankara, 06560
-
Turkey
Novartis Investigative Site
Recruiting
Fatih / Istanbul, 34093
-
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34662
-
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34890
-
Turkey
United Kingdom
Novartis Investigative Site
Recruiting
Stoke on Trent, ST46QG
Staffordshire
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]