Study of Adagrasib with Pembrolizumab and Chemotherapy for Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

2 1 1 1

What is this study about?

This clinical trial is focused on studying treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) in patients who have a specific genetic change called the KRAS G12C mutation. The study will explore the effectiveness of a new treatment combination that includes Adagrasib, a medication taken orally, along with Pembrolizumab, which is given through an infusion into a vein, and chemotherapy. The purpose of the study is to evaluate how well this combination works as a first-line treatment for patients with this type of lung cancer.

Participants in the study will receive the treatment over a period of time, and their response to the treatment will be monitored. The study will look at how the cancer responds to the treatment, how long the response lasts, and any side effects that may occur. The study will also measure the levels of Adagrasib in the body to understand how it is processed. The trial aims to provide valuable information on the safety and effectiveness of this treatment combination for patients with Advanced Non-Small Cell Lung Cancer with the KRAS G12C mutation.

The study is expected to continue until early 2028, with recruitment of participants starting in late 2024. This trial is an important step in finding new and effective treatments for patients with this specific type of lung cancer, potentially offering new hope for those affected by this condition.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient will be required to provide consent to participate in the trial.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination.

3 treatment initiation

The patient will begin treatment with adagrasib in combination with pembrolizumab and chemotherapy. The specific chemotherapy drugs used may include pemetrexed, carboplatin, and cisplatin.

4 medication administration

The patient will receive adagrasib orally. Pembrolizumab and chemotherapy drugs will be administered intravenously. The frequency and dosage will be determined by the study protocol.

5 monitoring and follow-up

The patient will be monitored regularly for response to treatment and any side effects. This includes regular blood tests and imaging studies to assess the cancer’s response.

6 evaluation of response

The patient’s response to the treatment will be evaluated using criteria such as the objective response rate and progression-free survival.

7 completion of treatment

Upon completion of the treatment phase, the patient will undergo a final assessment to evaluate the overall response and any long-term effects.

8 long-term follow-up

The patient may be required to participate in long-term follow-up to monitor for any delayed side effects and to assess the duration of response.

Who Can Join the Study?

The patient must have a confirmed diagnosis of advanced non-small cell lung cancer. This means the cancer is in the lungs and has either spread to other parts of the body or cannot be removed by surgery.
The cancer must have a specific genetic change called the KRAS G12C mutation. This is a change in the DNA of the cancer cells that can affect how the cancer grows.
The patient must be at least 18 years old. This means they must be an adult.
Both men and women can participate in the study.
The study is open to people who may be considered part of a vulnerable population. This term refers to groups of people who might need special protection or care, such as those with certain health conditions or social situations.

Who Cannot Join the Study?

Patients who do not have Advanced Non-Small Cell Lung Cancer cannot participate. This is a type of lung cancer that is more advanced.
Patients who do not have the KRAS G12C mutation cannot participate. This is a specific change in the cancer’s genetic material.
Patients who are not within the specified age range cannot participate. The study is for adults.
Patients who are not able to receive the combination of adagrasib, pembrolizumab, and chemotherapy cannot participate. These are specific treatments used in the study.
Patients who are part of a vulnerable population that the study does not include cannot participate. This means groups of people who might need special protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Intercommunal Creteil	Creteil	France
Comite Entreprise Paul Papin	Angers	France
Institut Gustave Roussy	Villejuif	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Centr Georges Francois Leclerc	Dijon	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
General University Hospital Of Larissa	Larissa	Greece
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Hopital Tenon	Paris	France
Orszagos Onkologiai Intezet	Budapest	Hungary
Med Polonia Sp. z o.o.	Poznan	Poland
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Hospital Son Llatzer	Palma	Spain
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Hospital Foch	Suresnes	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
University General Hospital Of Heraklion	Heraklion	Greece
Instytut Msf Sp. z o.o.	Lodz	Poland
AORN San Giuseppe Moscati Avellino	Avellino	Italy
Centre Francois Baclesse	Caen	France
Iskdxw Igglyrar Frhdwchoawbgl Ohwgwvuypyx	Rome	Italy
Fnkavfgtp Pyvw La Icwddjiyusrze Bkfmbnjzj Des Hovihksd Udvcincljbwjn Lj Puc	Madrid	Spain
Iuetrkyw Pjdbqqdhncpkuhv Cefcwz Cntjaj	Marseille	France
Htouprzd Ubidmwdnhsmme di A Crvksz	A Coruna Galicia	Spain
Mwgsyoyfxmvl Hvxzzmkm	Athens	Greece

Trial status

Country	Status	Recruitment Start
France	Not recruiting	02.12.2024
Greece	Not recruiting	02.12.2024
Hungary	Not recruiting	02.12.2024
Italy	Not recruiting	02.12.2024
Poland	Not recruiting	02.12.2024
Spain	Not recruiting	02.12.2024

Trial locations

Investigated drugs:

Adagrasib is a medication being studied for its potential to treat advanced non-small cell lung cancer (NSCLC) in patients with a specific genetic mutation known as KRAS G12C. It works by targeting and inhibiting the activity of the KRAS G12C protein, which is involved in the growth and spread of cancer cells.

Pembrolizumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It is used in combination with other treatments to enhance the immune response against cancer.

Chemotherapy refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used alongside other treatments to improve the overall effectiveness against advanced non-small cell lung cancer.

Investigated diseases:

Non-small cell lung cancer

Advanced Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its non-small cell nature, which means the cancer cells are larger than those found in small cell lung cancer. It is considered advanced when it has spread beyond the lungs to other parts of the body. The disease progresses as the cancer cells grow and divide uncontrollably, forming tumors that can interfere with normal lung function. Over time, these tumors may invade nearby tissues and organs, leading to further complications. The progression can vary significantly among individuals, depending on factors like genetic mutations and overall health.

Trial ID:

2023-503714-77-00

Protocol code:

849-017

NCT ID:

NCT05609578

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Adagrasib with Pembrolizumab and Chemotherapy for Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?