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: Sep 07, 2022

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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

Bulgaria
Novartis Investigative Site
Recruiting
Plovdiv, 4004
-
Bulgaria
Novartis Investigative Site
Recruiting
Russe, 7002
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1303
-
Bulgaria
Czech Republic
Novartis Investigative Site
Recruiting
Ostrava Vitkovice, 703 84
-
Czech Republic
Hungary
Novartis Investigative Site
Recruiting
Torokbalint, 2045
Pest
Hungary
Jordan
Novartis Investigative Site
Recruiting
Amman, 11941
-
Jordan
Lebanon
Novartis Investigative Site
Recruiting
Ashrafieh, 166830
-
Lebanon
Novartis Investigative Site
Recruiting
Saida, 652
-
Lebanon

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

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