Study of RMC-6291 and Pembrolizumab with or without Chemotherapy for Patients with Advanced KRAS G12C Mutated Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer known as lung cancer, specifically in patients with a certain genetic change called the KRAS G12C mutation. The study will explore the effects of a new treatment called RMC-6291, which will be used in combination with another medication called pembrolizumab. Pembrolizumab is a type of medicine that helps the immune system fight cancer. In some cases, the treatment may also include chemotherapy, which is a common cancer treatment that uses drugs to kill cancer cells.

The purpose of this study is to evaluate how safe and tolerable the combination of these treatments is for patients with advanced solid tumors that have the KRAS G12C mutation. The study will involve patients who have previously received cancer treatment and have at least one tumor that can be measured. Participants will receive the treatment over a period of time, and their health will be closely monitored to observe any side effects and how their body responds to the treatment.

Throughout the study, researchers will collect information on the levels of RMC-6291 in the blood and assess the overall response of the tumors to the treatment. The study aims to provide valuable insights into the potential benefits and risks of using RMC-6291 in combination with pembrolizumab and chemotherapy for treating lung cancer with the KRAS G12C mutation.

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 sign an informed consent form, confirming their understanding and willingness to participate.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying the presence of a KRAS mutation in the tumor and ensuring adequate organ function.

3 treatment phase

The patient will receive a combination of medications, including RMC-6291 and pembrolizumab. These medications are administered as a solution for infusion.

Depending on the specific protocol, the patient may also receive chemotherapy drugs such as cisplatin, carboplatin, or pemetrexed. These are also given as solutions for infusion.

The frequency and duration of administration will be determined by the study protocol and the patient’s response to treatment.

4 monitoring and follow-up

Throughout the trial, the patient will be closely monitored for any side effects or changes in health status. This includes regular laboratory tests, ECGs, and vital sign checks.

The patient will have scheduled follow-up visits to assess the effectiveness of the treatment and to make any necessary adjustments.

5 completion of the trial

Upon completion of the treatment phase, the patient will undergo a final assessment to evaluate the overall impact of the trial medications.

The patient will receive information about any further steps or additional follow-up that may be required.

Who Can Join the Study?

Must be at least 18 years old and have signed the Informed Consent Form, which is a document that explains the study and confirms your agreement to participate.
Must have a solid tumor with a specific change in the KRAS gene, known as a mutation.
Must have received cancer treatment before.
Must have at least one tumor lesion, which is an area of abnormal tissue, that can be measured by doctors.
Must have adequate organ function, meaning your bone marrow, liver, and kidneys are working well enough.

Who Cannot Join the Study?

Patients who have a different type of cancer other than the specific one being studied.
Patients who have not been diagnosed with the specific genetic mutation called KRAS G12C, which is a change in a gene that can affect cancer growth.
Patients who are not within the age range specified for the study.
Patients who are unable to follow the study procedures or take the study medications as required.
Patients who have other serious health conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
Patients who are participating in another clinical trial at the same time.
Patients who have had a recent major surgery or are recovering from a major surgery.
Patients who have had a recent infection that requires treatment with antibiotics or other medications.
Patients who have a history of allergic reactions to the study medications or similar drugs.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Technische Universitaet Dresden	Dresden	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Clinico San Carlos	Madrid	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
Hospital Universitario De Navarra	Pamplona	Spain
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Hospital Foch	Suresnes	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Netherlands Cancer Institute	Amsterdam	The Netherlands
Centre Hospitalier Lyon Sud	Pierre Benite	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centre Francois Baclesse	Caen	France
Lungenfachklinik Immenhausen	Immenhausen	Germany
Sfqfodzh Kctwoqrsbnf Byralnqgf Frua Djl Guzrtnljhx Msobw	Moers	Germany
Ilzlgd Iiydbjia Fpdyqeewcacng Ovuluuipcea	Rome	Italy
Lwnuf Uaoppvpcopvf Mfuhria Cjmmkye (putmu	Leiden	The Netherlands
Udatcamlduea Mxguqud Crzgsoa Gpgczxrnl	Groningen	The Netherlands
Unfkklfoiz Hlkktlcc Cgxqika	Cologne	Germany
Ibcymlci Rafqvgasv Pux Li Sfjzay Dzl Trfsol Drhj Azxzzha Icbg Sfhadu	Meldola	Italy
Gvimcy Uzqbjxegxy Fbfqilpjk	Frankfurt	Germany
Ibdogmmz Cpdqld Dteogrvawzybskbez	L'hospitalet De Llobregat	Spain
Hkcrndyg Vyfl dsstjmgo	Barcelona	Spain
Hglnzeqz Uygjuauyihrah dd A Csdkgq	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	24.08.2024
Germany	Recruiting	24.08.2024
Italy	Recruiting	24.08.2024
Spain	Recruiting	24.08.2024
The Netherlands	Recruiting	24.08.2024

Trial locations

Investigated drugs:

RMC-6291 is an investigational medication being studied for its potential to treat certain types of cancer. It is specifically being tested in patients with solid tumors that have a specific genetic mutation known as KRAS G12C. The role of RMC-6291 in the trial is to assess its safety and how well it is tolerated by patients when used in combination with other treatments.

Pembrolizumab is a medication that helps the immune system fight cancer. It is used in this trial to see how well it works with RMC-6291 in treating patients with KRAS G12C-mutated solid tumors. Pembrolizumab is already used in various cancer treatments and is known for its role in helping the body’s immune system recognize and attack cancer cells.

Chemotherapy refers to a group of cancer treatments that use powerful drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy may be used alongside RMC-6291 and pembrolizumab to evaluate the combined effect on patients with KRAS G12C-mutated solid tumors. The goal is to determine if adding chemotherapy improves the treatment outcomes.

Investigated diseases:

Non-small cell lung cancer

Lung Cancer – Lung cancer is a disease characterized by the uncontrolled growth of abnormal cells in one or both lungs. These abnormal cells do not develop into healthy lung tissue; instead, they divide rapidly and form tumors. As the tumors grow, they can interfere with the lung’s ability to provide oxygen to the bloodstream. The disease can spread to other parts of the body, a process known as metastasis. Lung cancer is often categorized into two main types: non-small cell lung cancer and small cell lung cancer, each with different growth patterns and spread rates. Symptoms may include persistent cough, chest pain, and shortness of breath.

Trial ID:

2023-509571-16-00

Protocol code:

RMC-LUNG-101A

NCT ID:

NCT06162221

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of RMC-6291 and Pembrolizumab with or without Chemotherapy for Patients with Advanced KRAS G12C Mutated Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?