Last Update: Feb 28, 2024
KontRASt-06: An Open-label Phase II Trial Evaluating the Activity and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.
ClinicalTrials.gov Identifier:
Novartis Reference Number:CJDQ443B12201
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 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.

Locally Advanced or Metastatic KRAS G12C-mutated NSCLC With a PD-L1 Expression <1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation
Phase 2
Recruiting
120
Dec 06, 2022
Nov 30, 2027
All
18 Years - (Adult, Older Adult)

Interventions

Drug

JDQ443

JDQ443 orally administered

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

Pilar,Buenos Aires,B1629AHJ,Argentina

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Cordoba,X5000JHQ,Argentina

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Cordoba,X5016KEH,Argentina

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Rosario,Santa Fe,S2000DSV,Argentina

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Buenos Aires,C1426AGE,Argentina

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Buenos Aires,Caba,C1431FWO,Argentina

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Wels,A-4600,Austria

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Feldkirch,A 6807,Austria

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Klagenfurt,9020,Austria

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Roeselare,8800,Belgium

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Sint Niklaas,Oost Vlaanderen,9100,Belgium

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Salvador,BA,41825-010,Brazil

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Rio de Janeiro,22271-110,Brazil

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Belo Horizonte,30360 680,Brazil

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Rio Grande Do Sul,90035-001,Brazil

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Sofia,1303,Bulgaria

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Branipole,4109,Bulgaria

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Plovdiv,4004,Bulgaria

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Wuhan,Hubei,430022,China

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Shanyang,110005,China

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Wuhan,Hubei,430030,China

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Beijing,100021,China

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Xian,Shanxi,710061,China

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Beijing,100036,China

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Zhengzhou,450008,China

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Changsha,Hunan,410013,China

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Montpellier,34070,France

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Strasbourg Cedex,67091,France

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Bron,69677,France

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Paris,75014,France

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Saint Herblain,44805,France

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Paris,75970,France

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Marseille cedex 20,Bouches Du Rhone,13915,France

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Berlin,13125,Germany

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Harburg,31787,Germany

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Hemer,58675,Germany

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Oldenburg,26121,Germany

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Kempten,87439,Germany

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Tuebingen,72076,Germany

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Halle (Saale),06120,Germany

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Athens,11526,Greece

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Athens,GR,115 27,Greece

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Matrahaza,3200,Hungary

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Torokbalint,Pest,2045,Hungary

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Kolkata,West Bengal,700160,India

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Puducherry,605006,India

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Varanasi,Uttarpradesh,221005,India

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Varese,VA,21100,Italy

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Roma,RM,00128,Italy

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Bari,BA,70124,Italy

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Orbassano,TO,10043,Italy

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Rozzano,MI,20089,Italy

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Kuantan,Pahang,25200,Malaysia

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Kuching,Sarawak,93586,Malaysia

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Alor Setar,Kedah,05460,Malaysia

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Pulau Pinang,10990,Malaysia

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Breda,4818 CK,Netherlands

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Leeuwarden,8934 AD,Netherlands

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Porto,4100-180,Portugal

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Lisboa,1998-018,Portugal

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Singapore,168583,Singapore

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Santander,Cantabria,39008,Spain

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Barcelona,Catalunya,08035,Spain

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Sevilla,Andalucia,41013,Spain

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Madrid,28041,Spain

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Bangkok,10700,Thailand

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Songkhla,Hat Yai,90110,Thailand

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Bangkok,10400,Thailand

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Adana,01140,Turkey

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Istanbul,34214,Turkey

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Diyarbakir,21000,Turkey

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Ankara,06560,Turkey

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Izmir,35575,Turkey

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Edirne,22030,Turkey

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Torquay,Devon,TQ2 7AA,United Kingdom

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

University of Toledo Precision Oncology

Recruiting

Toledo,Katherine Behrens email: [email protected] -- Danae Hamouda,43606 - Ohio,United States

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals