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Study of Efficacy 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.

Primary Purpose

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

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

JDQ443

About this trial

This is an interventional treatment trial for 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 focused on measuring Lung cancer, NSCLC, KRAS G12C, STK11, PD-L1, JDQ443

Eligibility Criteria

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

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).
Known active 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort A- PD-L1<1%

Cohort B- PD-L1≥ 1% and STK11 mutation

Arm Description

Participants whose tumors harbor a KRAS G12C mutation and a PD-L1 expression <1%, regardless of STK11 mutation status.

Participants whose tumors harbor a KRAS G12C mutation, a PD-L1 expression ≥ 1% and an STK11 co-mutation.

Outcomes

Primary Outcome Measures

Overall response rate (ORR) by blinded independent review committee (BIRC) in cohort A

ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per response evaluation criteria in solid tumors (RECIST) version 1.1 by BIRC in cohort A

Secondary Outcome Measures

ORR by BIRC in cohort B

ORR is defined as the percentage of participants with a CR or PR as BOR per RECIST 1.1 by BIRC in cohort B

Duration of response (DOR) by BIRC in both cohorts

DOR is defined as the time from the first occurrence of a PR or a CR per RECIST 1.1 by BIRC to the occurrence of disease progression or death due to any cause. DOR will be calculated separately for each of the two cohorts.

Progression Free Survival (PFS) by BIRC in both cohorts

PFS is defined as the time from the date of first dose of study treatment to the date of the first documented disease progression per RECIST 1.1 by BIRC or date of death due to any cause. PFS will be calculated separately for each of the two cohorts.

Overall survival (OS) in both cohorts

OS is defined as the time from the date of enrollment to the date of death due to any cause. OS will be calculated separately for each of the two cohorts.

Disease control rate (DCR) by BIRC in both cohorts

DCR is defined as the percentage of participants with a BOR of confirmed CR, PR and stable disease (SD) per RECIST 1.1 by BIRC. DCR will be calculated separately for each of the two cohorts.

Time to response (TTR) by BIRC in both cohorts

TTR is defined as the time from the date of enrollment to the date of first documented response of either CR or PR per RECIST 1.1 by BIRC. TTR will be calculated separately for each of the two cohorts.

ORR by local radiology assessment in both cohorts

ORR is defined as the percentage of participants with a CR or PR as BOR per RECIST 1.1 by local review assessment. ORR will be calculated separately for each of the two cohorts.

DOR by local review assessment in both cohorts

DOR is defined as the time from the first occurrence of a PR or a CR per RECIST 1.1 by local review assessment to the occurrence of disease progression or death due to any cause. DOR will be calculated separately for each of the two cohorts.

DCR by local review assessment in both cohorts

DCR is defined as the percentage of participants with a BOR of confirmed CR, PR and SD per RECIST 1.1 by local review assessment. DCR will be calculated separately for each of the two cohorts.

TTR by local review assessment in both cohorts

TTR is defined as the time from the date of enrollment to the date of first documented response of either CR or PR per RECIST 1.1 by local review assessment. TTR will be calculated separately for each of the two cohorts.

PFS by local review assessment in both cohorts

PFS is defined as the time from the date of first dose of study treatment to the date of the first documented disease progression per RECIST 1.1 by local review assessment or date of death due to any cause. PFS will be calculated separately for each of the two cohorts.

ORR by BIRC and local radiology assessment for participants whose tumors harbor an STK11 mutation regardless of PD-L1 expression status (pooled from both cohorts)

ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per RECIST 1.1 by local review assessment and by BIRC. ORR will be calculated for all participants whose tumors harbor an STK11 mutation by pooling participants from both cohorts

DOR by BIRC and local radiology assessment for participants whose tumors harbor an STK11 mutation regardless of PD-L1 expression status (pooled from both cohorts)

DOR is defined as the time from the first occurrence of a PR or a CR per RECIST 1.1 by local review assessment and by BIRC to the occurrence of disease progression or death due to any cause. DOR will be calculated for all participants whose tumors harbor an STK11 mutation by pooling participants from both cohorts.

DCR by BIRC and local radiology assessment for participants whose tumors harbor an STK11 mutation regardless of PD-L1 expression status (pooled from both cohorts)

DCR is defined as the percentage of participants with a BOR of confirmed CR, PR and stable disease (SD) per RECIST 1.1 by local review assessment and by BIRC. DCR will be calculated for all participants whose tumors harbor an STK11 mutation by pooling participants from both cohorts

TTR by BIRC and local radiology assessment for participants whose tumors harbor an STK11 mutation regardless of PD-L1 expression status (pooled from both cohorts)

TTR is defined as the time from the date of enrollment to the date of first documented response of either CR or PR per RECIST 1.1 by local review assessment and by BIRC. TTR will be calculated for all participants whose tumors harbor an STK11 mutation by pooling participants from both cohorts

PFS by BIRC and local radiology assessment for participants whose tumors harbor an STK11 mutation regardless of PD-L1 expression status (pooled from both cohorts)

PFS is defined as the time from the date of first dose of study treatment to the date of the first documented disease progression per RECIST 1.1 by local review assessment and BIRC or date of death due to any cause. PFS will be calculated for all participants whose tumors harbor an STK11 mutation by pooling participants from both cohorts

OS for participants whose tumors harbor an STK11 mutation regardless of PD-L1 expression status (pooled from both cohorts)

OS is defined as the time from the date of enrollment to the date of death due to any cause. OS will be calculated for all participants whose tumors harbor an STK11 mutation by pooling participants from both cohorts

Maximum concentration (Cmax) of JDQ443 in plasma

Blood samples will be collected for pharmacokinetics characterization.

Time to reach maximum concentration at steady-state (Tmax,ss) of JDQ443 in plasma

Blood samples will be collected for pharmacokinetics characterization.

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of JDQ443 in plasma

Blood samples will be collected for pharmacokinetics characterization.

Area Under the Curve From Time Zero to the last measurable concentration sampling time at steady-state (AUClastss) of JDQ443 in plasma

Blood samples will be collected for pharmacokinetics characterization.

Observed concentration at the end of a dosing interval at steady-state (Cmin,ss) of JDQ443 in plasma

Blood samples will be collected for pharmacokinetics characterization.

Total body clearance (CL/F) of JDQ443 from the plasma

Blood samples will be collected for pharmacokinetics characterization.

Time to definitive deterioration (TTDD) in NSCLC-SAQ total score

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: cough, pain, dyspnea, fatigue, and appetite.

TTDD in the physical functioning scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30

The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties).

Chain from baseline in NSCLC-SAQ

The NSCLC-SAQ is a 7-item, patient-reported outcome measure which assess patient-reported symptoms associated with advanced NSCLC: cough, pain, dyspnea, fatigue, and appetite.

Change from baseline in EORTC QLQ-C30

Full Information

NCT ID

NCT05445843

First Posted

June 30, 2022

Last Updated

October 2, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05445843

Brief Title

Study of Efficacy 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.

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 6, 2022 (Actual)

Primary Completion Date

November 2, 2026 (Anticipated)

Study Completion Date

November 30, 2027 (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

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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).

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the 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

Keywords

Lung cancer, NSCLC, KRAS G12C, STK11, PD-L1, JDQ443

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort A- PD-L1<1%

Arm Type

Experimental

Arm Description

Participants whose tumors harbor a KRAS G12C mutation and a PD-L1 expression <1%, regardless of STK11 mutation status.

Arm Title

Cohort B- PD-L1≥ 1% and STK11 mutation

Arm Type

Experimental

Arm Description

Participants whose tumors harbor a KRAS G12C mutation, a PD-L1 expression ≥ 1% and an STK11 co-mutation.

Intervention Type

Drug

Intervention Name(s)

JDQ443

Intervention Description

JDQ443 orally administered

Primary Outcome Measure Information:

Title

Overall response rate (ORR) by blinded independent review committee (BIRC) in cohort A

Description

Time Frame

Up to approximately 24 months

Secondary Outcome Measure Information:

Title

ORR by BIRC in cohort B

Description

ORR is defined as the percentage of participants with a CR or PR as BOR per RECIST 1.1 by BIRC in cohort B

Time Frame

Up to approximately 24 months

Title

Duration of response (DOR) by BIRC in both cohorts

Description

Time Frame

From first documented response to disease progression or death, up to approximately 24 months

Title

Progression Free Survival (PFS) by BIRC in both cohorts

Description

Time Frame

From first study treatment to first documented progression or death, up to approximately 24 months

Title

Overall survival (OS) in both cohorts

Description

OS is defined as the time from the date of enrollment to the date of death due to any cause. OS will be calculated separately for each of the two cohorts.

Time Frame

From enrollment to death, up to approximately 36 months

Title

Disease control rate (DCR) by BIRC in both cohorts

Description

DCR is defined as the percentage of participants with a BOR of confirmed CR, PR and stable disease (SD) per RECIST 1.1 by BIRC. DCR will be calculated separately for each of the two cohorts.

Time Frame

Up to approximately 24 months

Title

Time to response (TTR) by BIRC in both cohorts

Description

Time Frame

From enrollment to first documented response, up to approximately 24 months

Title

ORR by local radiology assessment in both cohorts

Description

ORR is defined as the percentage of participants with a CR or PR as BOR per RECIST 1.1 by local review assessment. ORR will be calculated separately for each of the two cohorts.

Time Frame

Up to approximately 24 months

Title

DOR by local review assessment in both cohorts

Description

Time Frame

From first documented response to disease progression or death, up to approximately 24 months

Title

DCR by local review assessment in both cohorts

Description

DCR is defined as the percentage of participants with a BOR of confirmed CR, PR and SD per RECIST 1.1 by local review assessment. DCR will be calculated separately for each of the two cohorts.

Time Frame

Up to approximately 24 months

Title

TTR by local review assessment in both cohorts

Description

Time Frame

From enrollment to first documented response, up to approximately 24 months

Title

PFS by local review assessment in both cohorts

Description

Time Frame

From first study treatment to first documented progression or death, up to approximately 24 months

Title

ORR by BIRC and local radiology assessment for participants whose tumors harbor an STK11 mutation regardless of PD-L1 expression status (pooled from both cohorts)

Description

Time Frame

Up to approximately 24 months

Title

DOR by BIRC and local radiology assessment for participants whose tumors harbor an STK11 mutation regardless of PD-L1 expression status (pooled from both cohorts)

Description

Time Frame

From first documented response to disease progression or death, up to approximately 24 months

Title

DCR by BIRC and local radiology assessment for participants whose tumors harbor an STK11 mutation regardless of PD-L1 expression status (pooled from both cohorts)

Description

Time Frame

Up to approximately 24 months

Title

TTR by BIRC and local radiology assessment for participants whose tumors harbor an STK11 mutation regardless of PD-L1 expression status (pooled from both cohorts)

Description

Time Frame

From enrollment to first documented response, up to approximately 24 months

Title

PFS by BIRC and local radiology assessment for participants whose tumors harbor an STK11 mutation regardless of PD-L1 expression status (pooled from both cohorts)

Description

Time Frame

From first study treatment to first documented progression or death, up to 24 months

Title

OS for participants whose tumors harbor an STK11 mutation regardless of PD-L1 expression status (pooled from both cohorts)

Description

Time Frame

From enrollment to death, up to approximately 36 months

Title

Maximum concentration (Cmax) of JDQ443 in plasma

Description

Blood samples will be collected for pharmacokinetics characterization.

Time Frame

Up to approximately 24 months

Title

Time to reach maximum concentration at steady-state (Tmax,ss) of JDQ443 in plasma

Description

Blood samples will be collected for pharmacokinetics characterization.

Time Frame

Up to approximately 24 months

Title

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of JDQ443 in plasma

Description

Blood samples will be collected for pharmacokinetics characterization.

Time Frame

Up to approximately 24 months

Title

Area Under the Curve From Time Zero to the last measurable concentration sampling time at steady-state (AUClastss) of JDQ443 in plasma

Description

Blood samples will be collected for pharmacokinetics characterization.

Time Frame

Up to approximately 24 months

Title

Observed concentration at the end of a dosing interval at steady-state (Cmin,ss) of JDQ443 in plasma

Description

Blood samples will be collected for pharmacokinetics characterization.

Time Frame

Up to approximately 24 months

Title

Total body clearance (CL/F) of JDQ443 from the plasma

Description

Blood samples will be collected for pharmacokinetics characterization.

Time Frame

Up to approximately 24 months

Title

Time to definitive deterioration (TTDD) in NSCLC-SAQ total score

Description

Time Frame

From baseline up to approximately 24 months

Title

TTDD in the physical functioning scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30

Description

Time Frame

From baseline up to approximately 24 months

Title

Chain from baseline in NSCLC-SAQ

Description

The NSCLC-SAQ is a 7-item, patient-reported outcome measure which assess patient-reported symptoms associated with advanced NSCLC: cough, pain, dyspnea, fatigue, and appetite.

Time Frame

From baseline up to approximately 24 months

Title

Change from baseline in EORTC QLQ-C30

Description

Time Frame

From baseline up to approximately 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

1-888-669-6682

novartis.email@novartis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

+41613241111

Facility Information:

Facility Name

The Brown University Oncology Group

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Jarbadan

Phone

401-444-5435

rjarbadan@lifespan.org

First Name & Middle Initial & Last Name & Degree

Christopher Azzoli

Facility Name

Novartis Investigative Site

City

Buenos Aires

State/Province

Caba

ZIP/Postal Code

C1431FWO

Country

Argentina

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DSV

Country

Argentina

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1426AGE

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

Cordoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Feldkirch

ZIP/Postal Code

A 6807

Country

Austria

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Klagenfurt

ZIP/Postal Code

9020

Country

Austria

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Wels

ZIP/Postal Code

A-4600

Country

Austria

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sint Niklaas

State/Province

Oost Vlaanderen

ZIP/Postal Code

9100

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Salvador

State/Province

ZIP/Postal Code

41825-010

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Belo Horizonte

ZIP/Postal Code

30360 680

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Rio de Janeiro

ZIP/Postal Code

22271-110

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

Branipole

ZIP/Postal Code

4109

Country

Bulgaria

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

Sofia

ZIP/Postal Code

1303

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Guang Zhou

State/Province

Guang Dong Province

ZIP/Postal Code

510120

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

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410013

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Xian

State/Province

Shanxi

ZIP/Postal Code

710061

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100021

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

Shanyang

ZIP/Postal Code

110005

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Zhengzhou

ZIP/Postal Code

450008

Country

China

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Marseille cedex 20

State/Province

Bouches Du Rhone

ZIP/Postal Code

13915

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bron

ZIP/Postal Code

69677

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Montpellier

ZIP/Postal Code

34070

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75014

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75970

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Strasbourg Cedex

ZIP/Postal Code

67091

Country

France

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Halle (Saale)

ZIP/Postal Code

06120

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Harburg

ZIP/Postal Code

31787

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Hemer

ZIP/Postal Code

58675

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kempten

ZIP/Postal Code

87439

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Oldenburg

ZIP/Postal Code

26121

Country

Germany

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

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

Torokbalint

State/Province

Pest

ZIP/Postal Code

2045

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Matrahaza

ZIP/Postal Code

3200

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bari

State/Province

ZIP/Postal Code

70124

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Rozzano

State/Province

ZIP/Postal Code

20089

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00128

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Orbassano

State/Province

ZIP/Postal Code

10043

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Varese

State/Province

ZIP/Postal Code

21100

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Alor Setar

State/Province

Kedah

ZIP/Postal Code

05460

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kuantan

State/Province

Pahang

ZIP/Postal Code

25200

Country

Malaysia

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

Pulau Pinang

ZIP/Postal Code

10990

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

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

Porto

ZIP/Postal Code

4100-180

Country

Portugal

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41013

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Songkhla

State/Province

Hat Yai

ZIP/Postal Code

90110

Country

Thailand

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

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

Diyarbakir

ZIP/Postal Code

21000

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34214

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35575

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Torquay

State/Province

Devon

ZIP/Postal Code

TQ2 7AA

Country

United Kingdom

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 www.clinicalstudydatarequest.com

Learn more about this trial

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Study of Efficacy 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.

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

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial