Study on JDQ443 for First-Line Treatment in Patients with Advanced KRAS G12C-Mutated Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC) that has a specific genetic change called the KRAS G12C mutation. This mutation is found in some patients with advanced stages of NSCLC. The study is testing a new treatment called JDQ443, which is taken as a tablet. JDQ443 is being evaluated as a first-line treatment, meaning it is the first treatment given for this type of cancer.

The purpose of the study is to assess how well JDQ443 works and how safe it is for patients with this specific type of lung cancer. The study will include patients whose cancer has spread locally or to other parts of the body, and who have not received any previous treatment for their advanced cancer. The study will also consider the presence of another genetic factor called PD-L1 expression, which can be either less than 1% or 1% and above, and may include an additional genetic change known as an STK11 co-mutation.

Participants in the study will take JDQ443 orally, and the study will monitor their response to the treatment over time. The study aims to understand the overall response rate, which is the proportion of patients who experience a reduction in their cancer size. It will also look at how long the response lasts, the time it takes for the cancer to progress, and overall survival rates. Additionally, the study will track any side effects or changes in health indicators such as laboratory values and vital signs. The trial is expected to continue until October 2025.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria, including the presence of a KRAS G12C mutation in non-small cell lung cancer (NSCLC) and the ability to swallow medication.

Participants must have a measurable lesion and an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.

2 treatment initiation

The treatment involves taking a medication called JDQ443, which is administered orally in the form of a tablet.

The dosage and frequency of administration are determined by the study protocol and are designed to assess the antitumor activity of JDQ443 as a first-line treatment.

3 monitoring and assessments

Regular monitoring is conducted to evaluate the response to treatment. This includes imaging tests to measure tumor size and assess overall response rate (ORR), which is the proportion of participants with a confirmed complete or partial response.

Additional assessments include monitoring for any side effects, changes in laboratory values, vital signs, and electrocardiograms (ECGs).

4 follow-up evaluations

Participants undergo follow-up evaluations to determine the duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

These evaluations help in understanding the time from the first response to disease progression or death, and the overall time from enrollment to death.

5 completion of study

The study is estimated to conclude by October 31, 2025. Participants will continue to be monitored until the end of the study or until they meet criteria for discontinuation.

Final assessments will include a comprehensive review of the treatment’s efficacy and safety, as well as any changes in quality of life as measured by specific questionnaires.

Who Can Join the Study?

The patient must have a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (meaning it has spread to nearby areas but not far away) or metastatic (meaning it has spread to other parts of the body).
The cancer must have a specific genetic change called a KRAS G12C mutation.
The patient must not have had any previous treatments that affect the whole body for their metastatic cancer. However, if they had treatments like chemotherapy or immunotherapy for earlier stages of cancer, it is okay if it was more than 12 months ago.
The patient must have at least one cancer area that can be measured by doctors using a standard method called RECIST 1.1.
The patient must have a PD-L1 expression level, which is a measure of a protein on cancer cells, that is either less than 1% or 1% or more with another genetic change called an STK11 co-mutation.
The patient must be able to swallow the medication used in the study.
The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The patient must be within the age range that includes adults and older adults.
Both male and female patients can participate.
The study may include people who are considered vulnerable, meaning they might need extra protection or care.

Who Cannot Join the Study?

Patients who do not have a specific type of lung cancer called KRAS G12C-mutated non-small cell lung cancer.
Patients whose cancer does not have a PD-L1 expression of less than 1% or greater than or equal to 1% with an STK11 co-mutation. PD-L1 expression is a measure of a protein that can affect how the immune system responds to cancer. An STK11 co-mutation is a change in a specific gene that can occur alongside other mutations.
Patients who are not in the age range specified for the study.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Frisius	Heerenveen	The Netherlands
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Pius-Hospital Oldenburg	Oldenburg In Holstein	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Klinikum Wels-Grieskirchen GmbH	Wels	Austria
Amphia Hospital	Breda	The Netherlands
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Vitaz	Sint-Niklaas	Belgium
Hospital Cuf Descobertas S.A.	Lisbon	Portugal
Centre De Cancerologue Du Grand Montpellier	Montpellier	France
Martha-Maria Krankenhaus Halle-Doelau gGmbH	Halle (Saale)	Germany
Henry Dunant Hospital Center	Athens	Greece
Klinikverbund Allgaeu gGmbH	Kempten (Allgau)	Germany
Matrai Gyogyintezet	Gyongyos	Hungary
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH	Feldkirch	Austria
Tuedogyogyintezet Toeroekbalint	Torokbalint	Hungary
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Hospital CUF Porto S.A.	Porto	Portugal
Anqpeufxwq Pmplzvkc Hlnnwjxd Du Mrbpzwmas	Marseille	France
Haqhwuht Vwff drelaxnl	Barcelona	Spain
Hxgysppo Uwphmjzhdtuuzf Scauqekgia &chmjus Hhsvhau dw Hbrrwmmemcr	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	06.12.2022
Belgium	Not yet recruiting	06.12.2022
France	Not yet recruiting	06.12.2022
Germany	Not yet recruiting	06.12.2022
Greece	Not recruiting	06.12.2022
Hungary	Not recruiting	06.12.2022
Italy	Not recruiting	06.12.2022
Portugal	Not recruiting	06.12.2022
Spain	Not yet recruiting	06.12.2022
The Netherlands	Not recruiting	06.12.2022

Trial locations

Investigated drugs:

1-{6-[(4M)-4-(5-Chloro-6-Methyl-1H -Indazol-4-Yl)-5-Methyl-3-(1-Methyl-1H -Indazol-5-Yl)-1H -Pyrazol-1-Yl]-2-Azaspiro[3.3]Heptan-2-Yl}Prop-2-En-1-One

JDQ443 is a medication being studied as a first-line treatment for patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC). This medication is being tested in patients whose cancer has a mutation called KRAS G12C. The trial is looking at how well JDQ443 works in shrinking or controlling the cancer and its safety for patients. The study includes patients with different levels of a protein called PD-L1, which can affect how the cancer behaves and responds to treatment.

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. The disease can be locally advanced, meaning it has spread to nearby tissues, or metastatic, indicating it has spread to other parts of the body. In some cases, specific genetic mutations, such as KRAS G12C, can be present, influencing the cancer’s behavior and progression. The expression of proteins like PD-L1 can also vary, affecting how the cancer interacts with the immune system. Co-mutations, such as those in the STK11 gene, may further impact the disease’s characteristics and progression.

Trial ID:

2024-511708-18-00

Protocol code:

CJDQ443B12201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on JDQ443 for First-Line Treatment in Patients with Advanced KRAS G12C-Mutated Non-Small Cell Lung Cancer

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