Study of RMC-6236 and Pembrolizumab with or without Chemotherapy for Patients with RAS-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 specific changes in the RAS gene. The study will explore the effects of a new treatment called RMC-6236, which will be used in combination with another medication called pembrolizumab. Pembrolizumab is a type of medicine that helps the immune system fight cancer. Some participants may also receive additional chemotherapy, which is a treatment that uses drugs to kill cancer cells.

The purpose of this study is to understand how safe and tolerable the combination of these treatments is for patients with advanced RAS-mutated NSCLC. The study will involve several steps over a period of time. Participants will receive the treatments and will be monitored closely by healthcare professionals. The study will look at how the body responds to the treatments and any side effects that may occur. The study will also measure the levels of RMC-6236 in the blood over time to understand how the body processes the drug.

Participants in the study will be those who have NSCLC that has spread to other parts of the body and have previously received cancer treatment. The study will help gather important information that could lead to better treatment options for people with this type of lung cancer in the future.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose, which is to evaluate the safety and tolerability of the medication RMC-6236 in combination with pembrolizumab, with or without chemotherapy, for patients with advanced lung cancer with specific mutations.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying the presence of specific mutations in lung cancer, ensuring the cancer has spread to other parts of the body, and confirming previous cancer treatments. Adequate organ function will also be assessed.

3 treatment phase

The treatment phase involves administering RMC-6236 orally. The exact dosage and frequency will be determined by the study protocol.

In addition, pembrolizumab will be given as a solution for infusion. The frequency and duration of this treatment will be specified in the study protocol.

Depending on the study group, chemotherapy may also be administered. This could include medications such as carboplatin, cisplatin, or pemetrexed, all given as solutions for infusion.

4 monitoring and follow-up

Throughout the trial, the patient will be monitored for any side effects or adverse reactions. This includes regular laboratory tests, ECGs, and vital sign checks.

The concentration of RMC-6236 in the blood will be measured over time to understand how the body processes the medication.

5 completion of the trial

The trial is expected to continue until January 30, 2026. Upon completion, the patient’s overall response to the treatment will be evaluated, including the duration of response and any changes in tumor size.

Who Can Join the Study?

Patients must be at least 18 years old.
Patients must have a type of lung cancer called NSCLC with certain RAS mutations. NSCLC stands for Non-Small Cell Lung Cancer, which is a common type of lung cancer. RAS mutations are changes in a specific gene that can affect cancer growth.
Patients must have lung cancer that is unlikely to be cured and has spread to other parts of the body.
Patients must have received previous treatment for cancer.
Patients must have at least one tumor lesion that can be measured. A tumor lesion is an area of abnormal tissue that can be seen and measured.
Patients must have adequate organ function, meaning their bone marrow, liver, and kidneys are working well enough.

Who Cannot Join the Study?

Patients who have a different type of cancer other than lung cancer cannot participate.
Patients who do not have the specific RAS mutation in their lung cancer are excluded. A mutation is a change in the DNA that can affect how cells grow.
Patients who are not in the age range specified for the study cannot join. The study is for adults only.
Patients who are not able to understand or follow the study procedures will not be included.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have other serious health conditions that might interfere with the study treatment are excluded.
Patients who have had another cancer treatment recently that might interfere with the study treatment cannot join.
Patients who have allergies to the study drugs or similar drugs are excluded.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

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
Lungenfachklinik	Immenhausen	Germany
Hospital Clinico San Carlos	Madrid	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
Hospital Universitario De Navarra	Pamplona	Spain

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
Sksaumcm Kkxfyfxkakq Byuixvthz Fyng Dwu Gnxvvjcclo Menel	Moers	Germany
Ipptzq Imjhkptw Fieulfaozrcpw Oqqtorhqlzj	Rome	Italy
Lfkck Uymjjletnfjv Mzdarcu Ctqjpba (mdgud	Leiden	The Netherlands
Umfvbjtruvlx Mcidazo Cgqjuon Glpxscfjm	Groningen	The Netherlands
Uqkmettlqu Hrmbnhrj Cqovliv	Cologne	Germany
Igimbadx Rsipkwclw Pob Lf Suviwm Dke Twzqcy Dmbh Ahckeur Iujn Sdfxen	Meldola	Italy
Gnzwof Umzrhapulb Fewddvcsc	Frankfurt	Germany
Istudukn Cjtorm Dnjpijgvlwomvrzfe	L'hospitalet De Llobregat	Spain
Hgnzbopa Vggf dptcjqql	Barcelona	Spain
Hcbjbzqa Ucvedctoyuxbq dz A Cplffy	A Coruna Galicia	Spain
Insmxwik Cawyo	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	28.08.2024
Germany	Recruiting	28.08.2024
Italy	Recruiting	28.08.2024
Spain	Recruiting	28.08.2024
The Netherlands	Recruiting	28.08.2024

Trial locations

Investigated drugs:

RMC-6236 is an investigational medication being studied for its potential to treat patients with non-small cell lung cancer (NSCLC) that has a specific mutation known as RAS. This medication is being tested to see if it can help control the growth of cancer cells in patients with this type of mutation.

Pembrolizumab is a type of immunotherapy that helps the body’s immune system recognize and attack cancer cells. It is used in this study to see if it can work together with RMC-6236 to improve treatment outcomes for patients with RAS-mutated NSCLC.

Chemotherapy is a treatment that uses drugs to kill cancer cells or stop them from growing. In this study, chemotherapy may be used alongside RMC-6236 and pembrolizumab to see if the combination can be more effective in treating patients with advanced RAS-mutated NSCLC.

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 disease progresses, these tumors can interfere with the lung’s ability to provide oxygen to the bloodstream. Lung cancer can spread to other parts of the body, a process known as metastasis. The disease is often categorized into two main types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with NSCLC being the more common type. Symptoms may include persistent cough, chest pain, and shortness of breath, but they often appear only in advanced stages.

Trial ID:

2023-509572-42-00

Protocol code:

RMC-LUNG-101B

NCT ID:

NCT06162221

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of RMC-6236 and Pembrolizumab with or without Chemotherapy for Patients with RAS-Mutated Non-Small Cell Lung Cancer

What is this study about?

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