Study Description
This study aims to assess the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a KRAS G12C mutation and a PD-L1 expression < 1% regardless of STK11 mutation status (cohort A), or a PD-L1 expression ≥ 1% and an STK11 co-mutation (cohort B).
This is a non-randomized, open-label, single arm, multicenter, phase II study evaluating the antitumor activity and safety of JDQ443 single agent as first-line treatment for participants with locally advanced or metastatic KRAS G12C-mutated NSCLC. The study will have 2 non-comparative cohorts (Cohort A and B) that will recruit participants in parallel.
The study treatment begins on Cycle 1 Day 1 (C1D1) with the first administration of JDQ443. Each cycle is 21 days.
Study completion is defined as the earliest occurrence of one of the following:
The last participant completes last study visit (and the assessments associated with this visit have been documented and followed-up appropriately by the Investigator), dies, withdraws consent or is lost to follow-up, whichever comes first.
In the event of an early study termination decision, the date of that decision.
Another clinical study becomes available that can continue to provide JDQ443 to study participants and all participants with ongoing treatment are transferred to that clinical study.
Interventions
JDQ443
Eligibility Criteria
Key Inclusion criteria
Histologically confirmed locally advanced (stage IIIb/IIIc not eligible for definitive chemoradiation or surgical resection with curative intent) or metastatic (stage IV) NSCLC without previous systemic treatment for metastatic disease. Prior (neo)adjuvant treatment with chemotherapy and/or immunotherapy, or prior radiotherapy administered sequentially or concomitantly with chemotherapy and/or immunotherapy for localized or locally advanced disease are accepted if the time between therapy completion and enrollment is > 12 months.
Presence of a KRAS G12C mutation (all participants) and:
Cohort A: PD-L1 expression < 1%, regardless of STK11 mutation status
Cohort B: PD-L1 expression ≥ 1% and an STK11 co-mutation
At least one measurable lesion per RECIST 1.1.
ECOG performance status ≤ 1.
Participants capable of swallowing study medication.
Key Exclusion criteria
Participants whose tumors harbor an EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other known druggable alterations will be excluded, if required by local guidelines
Previous use of a KRAS G12C inhibitor or previous systemic treatment for metastatic NSCLC.
A medical condition that results in increased photosensitivity (i.e. solar urticaria, lupus erythematosus, etc).
Know active (unstable/symptomatic) central nervous system (CNS) metastases and/or carcinomatous meningitis
Participants who are taking a prohibited medication (strong CYP3A inducers) that cannot be discontinued at least seven days prior to the first dose of study treatment and for the duration of the study
Other inclusion/exclusion criteria may apply
Study Location
Novartis Investigative Site
Recruiting
Cordoba,X5016KEH,Argentina
Novartis Investigative Site
Recruiting
Rosario,Santa Fe,S2000DSV,Argentina
Novartis Investigative Site
Recruiting
Buenos Aires,C1426AGE,Argentina
Novartis Investigative Site
Recruiting
Buenos Aires,Caba,C1431FWO,Argentina
Novartis Investigative Site
Recruiting
Pilar,Buenos Aires,B1629AHJ,Argentina
Novartis Investigative Site
Recruiting
Cordoba,X5000JHQ,Argentina
Novartis Investigative Site
Recruiting
Wels,A-4600,Austria
Novartis Investigative Site
Recruiting
Feldkirch,A 6807,Austria
Novartis Investigative Site
Recruiting
Klagenfurt,9020,Austria
Novartis Investigative Site
Recruiting
Sint Niklaas,Oost Vlaanderen,9100,Belgium
Novartis Investigative Site
Recruiting
Roeselare,8800,Belgium
Novartis Investigative Site
Recruiting
Rio de Janeiro,22271-110,Brazil
Novartis Investigative Site
Recruiting
Belo Horizonte,30360 680,Brazil
Novartis Investigative Site
Recruiting
Rio Grande Do Sul,90035-001,Brazil
Novartis Investigative Site
Recruiting
Salvador,BA,41825-010,Brazil
Novartis Investigative Site
Recruiting
Sofia,1303,Bulgaria
Novartis Investigative Site
Recruiting
Plovdiv,4004,Bulgaria
Novartis Investigative Site
Recruiting
Branipole,4109,Bulgaria
Novartis Investigative Site
Recruiting
Wuhan,Hubei,430022,China
Novartis Investigative Site
Recruiting
Beijing,100021,China
Novartis Investigative Site
Recruiting
Shanyang,110005,China
Novartis Investigative Site
Recruiting
Wuhan,Hubei,430030,China
Novartis Investigative Site
Recruiting
Beijing,100036,China
Novartis Investigative Site
Recruiting
Xian,Shanxi,710061,China
Novartis Investigative Site
Recruiting
Zhengzhou,450008,China
Novartis Investigative Site
Recruiting
Changsha,Hunan,410013,China
Novartis Investigative Site
Recruiting
Montpellier,34070,France
Novartis Investigative Site
Recruiting
Strasbourg Cedex,67091,France
Novartis Investigative Site
Recruiting
Bron,69677,France
Novartis Investigative Site
Recruiting
Paris,75014,France
Novartis Investigative Site
Recruiting
Saint Herblain,44805,France
Novartis Investigative Site
Recruiting
Paris,75970,France
Novartis Investigative Site
Recruiting
Marseille cedex 20,Bouches Du Rhone,13915,France
Novartis Investigative Site
Recruiting
Oldenburg,26121,Germany
Novartis Investigative Site
Recruiting
Kempten,87439,Germany
Novartis Investigative Site
Recruiting
Tuebingen,72076,Germany
Novartis Investigative Site
Recruiting
Halle (Saale),06120,Germany
Novartis Investigative Site
Recruiting
Berlin,13125,Germany
Novartis Investigative Site
Recruiting
Harburg,31787,Germany
Novartis Investigative Site
Recruiting
Hemer,58675,Germany
Novartis Investigative Site
Recruiting
Athens,11526,Greece
Novartis Investigative Site
Recruiting
Athens,GR,115 27,Greece
Novartis Investigative Site
Recruiting
Torokbalint,Pest,2045,Hungary
Novartis Investigative Site
Recruiting
Matrahaza,3200,Hungary
Novartis Investigative Site
Recruiting
Puducherry,605006,India
Novartis Investigative Site
Recruiting
Varanasi,Uttarpradesh,221005,India
Novartis Investigative Site
Recruiting
Kolkata,West Bengal,700160,India
Novartis Investigative Site
Recruiting
Roma,RM,00128,Italy
Novartis Investigative Site
Recruiting
Bari,BA,70124,Italy
Novartis Investigative Site
Recruiting
Orbassano,TO,10043,Italy
Novartis Investigative Site
Recruiting
Rozzano,MI,20089,Italy
Novartis Investigative Site
Recruiting
Varese,VA,21100,Italy
Novartis Investigative Site
Recruiting
Alor Setar,Kedah,05460,Malaysia
Novartis Investigative Site
Recruiting
Kuching,Sarawak,93586,Malaysia
Novartis Investigative Site
Recruiting
Pulau Pinang,10990,Malaysia
Novartis Investigative Site
Recruiting
Kuantan,Pahang,25200,Malaysia
Novartis Investigative Site
Recruiting
Breda,4818 CK,Netherlands
Novartis Investigative Site
Recruiting
Leeuwarden,8934 AD,Netherlands
Novartis Investigative Site
Recruiting
Porto,4100-180,Portugal
Novartis Investigative Site
Recruiting
Lisboa,1998-018,Portugal
Novartis Investigative Site
Recruiting
Singapore,168583,Singapore
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08035,Spain
Novartis Investigative Site
Recruiting
Santander,Cantabria,39008,Spain
Novartis Investigative Site
Recruiting
Sevilla,Andalucia,41013,Spain
Novartis Investigative Site
Recruiting
Madrid,28041,Spain
Novartis Investigative Site
Recruiting
Bangkok,10400,Thailand
Novartis Investigative Site
Recruiting
Bangkok,10700,Thailand
Novartis Investigative Site
Recruiting
Songkhla,Hat Yai,90110,Thailand
Novartis Investigative Site
Recruiting
Istanbul,34214,Turkey
Novartis Investigative Site
Recruiting
Diyarbakir,21000,Turkey
Novartis Investigative Site
Recruiting
Ankara,06560,Turkey
Novartis Investigative Site
Recruiting
Izmir,35575,Turkey
Novartis Investigative Site
Recruiting
Edirne,22030,Turkey
Novartis Investigative Site
Recruiting
Adana,01140,Turkey
Novartis Investigative Site
Recruiting
Torquay,Devon,TQ2 7AA,United Kingdom
University of Toledo Precision Oncology
Recruiting
Toledo,Katherine Behrens email: [email protected] -- Danae Hamouda,43606 - Ohio,United States
Hartford Hospital
Recruiting
Hartford,Joshua Lopez (860-545-5000) email: [email protected] -- Wylie Hosmer,06102 - Connecticut,United States
The Brown University Oncology Group
Recruiting
Providence,Robert Jarbadan (401-444-5435) email: [email protected] -- Christopher Azzoli,02903 - Rhode Island,United States
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.