Study of adagrasib in elderly patients (70 years or older) or patients with poor performance status who have KRAS G12C mutation-positive non-small cell lung cancer

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What is this study about?

This study focuses on treating patients with non-small cell lung cancer (NSCLC) that has a specific genetic change called KRASG12C mutation. The study will evaluate a medication called adagrasib (also known as MRTX849), which is given as a film-coated tablet that patients take by mouth. This drug works by blocking a specific protein that contributes to cancer growth.

The research aims to determine how well adagrasib works in treating two specific groups of patients: elderly individuals (70 years and older) and those who have more difficulty performing daily activities due to their cancer. The medication is designed to specifically target lung cancer cells that have the KRASG12C mutation, which is a change in the genetic material of cancer cells.

During the study, participants will receive adagrasib tablets daily. The treatment may continue for up to 13 months, with regular check-ups to monitor how well the treatment is working and any side effects. The maximum daily dose of the medication is 1200 milligrams. Doctors will evaluate how the tumors respond to treatment, how long the treatment remains effective, and how it affects patients’ overall health and well-being.

1 Initial medication phase

You will receive adagrasib in the form of film-coated tablets that you will take by mouth

The treatment is intended for patients with non-small cell lung cancer who have a specific genetic change called KRASG12C mutation

2 Treatment monitoring at 12 weeks

Your response to treatment will be evaluated after 12 weeks of taking the medication

Medical imaging will be performed to measure if tumors have responded to the treatment

Your doctor will assess the results using standardized criteria (RECIST v1.1)

3 Ongoing assessment phase

Regular monitoring of your blood counts, kidney function, and liver function will be performed

Your overall health status and ability to perform daily activities will be evaluated

You will be asked about how you are feeling and any side effects you may experience

4 Long-term follow-up

Your progress will be tracked to measure how long the treatment remains effective

The medical team will monitor your overall survival and quality of life

The study will continue until June 2026

Who Can Join the Study?

Must be at least 18 years old
Must have confirmed stage IV non-small cell lung cancer (NSCLC)
Must have a specific genetic mutation called KRASG12C confirmed by tissue or blood testing
Must have received at least one previous treatment for lung cancer (such as chemotherapy or immunotherapy)
Must have a life expectancy of at least 12 weeks
Must have measurable disease that can be monitored through scans
Must belong to one of these groups:
- Group 1: Age 18 or older with limited ability to perform daily activities (ECOG PS=2)
- Group 2: Age 70 or older with good ability to perform daily activities (ECOG PS=0-1)
Must have adequate blood cell counts, and proper kidney and liver function
Must have a negative pregnancy test if able to become pregnant
Must be able to follow the study protocol requirements
Must provide written informed consent before starting any study procedures

Who Cannot Join the Study?

Prior treatment with a KRAS G12C inhibitor (a type of targeted cancer therapy)
Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
History of other cancers within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
Significant heart conditions, including:
- Heart attack within the past 6 months
- Unstable angina (chest pain)
- Heart failure requiring treatment
Active, uncontrolled infections
Known allergy or sensitivity to the study medication or its components
Pregnancy or breastfeeding
Inability to swallow oral medications
Any serious medical condition that could interfere with study participation
Current participation in other clinical trials or use of investigational drugs within 28 days before starting this study
Any condition that, in the investigator’s opinion, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Hospital Santa Maria Della Misericordia	Perugia	Italy
University Hospital Limerick	Limerick	Ireland
Hospital Universitario Basurto	Bilbao	Spain
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Centre Hospitalier D Avignon	Avignon	France
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Centre Hospitalier Le Mans	Le Mans	France
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hospital General Universitario De Alicante	Alicante	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Beaumont Hospital	Dublin	Ireland
Crzy Uobulynoon Hsymvirs	Cork	Ireland
Iovansyc Clmvkh Dxekluczhwqqlkekn	L'hospitalet De Llobregat	Spain
Abnhezgwma Pppdirqh Hgqgjvdi Dq Mlxoqagju	Marseille	France
Iytqze Inamxjbo Fdtlwhbjdhboq Oqplgudodos	Rome	Italy
Hrpcxenu Ukbcsrdfkdhcq Hcaspenz Tmvds y Pegwgq Iprvnuta Ccbdgr drfmgqdplnqvxflbr (rlpy	Badalona	Spain
Hebqexbh Ushivobjbaayo dr A Cqofbj	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	12.06.2023
France	Not recruiting	12.06.2023
Ireland	Not recruiting	12.06.2023
Italy	Not recruiting	12.06.2023
Spain	Not recruiting	12.06.2023

Trial locations

Investigated drugs:

Adagrasib

Adagrasib is a targeted therapy medication used to treat non-small cell lung cancer (NSCLC) in patients whose cancer has a specific genetic mutation called KRAS G12C. This medication works by blocking the abnormal KRAS protein that helps cancer cells grow and spread. It is taken orally and is specifically designed to help patients who may be elderly or have limited physical functioning due to their condition.

Investigated diseases:

Non-small cell lung cancer

Non-small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation – A specific type of lung cancer characterized by a mutation in the KRAS gene at position G12C. This cancer begins in the lung tissues, specifically in cells that are not small cell type. The disease develops when lung cells with this particular genetic mutation begin to grow uncontrollably and form tumors. NSCLC with KRAS G12C mutation represents a distinct molecular subtype of lung cancer that affects the way cells grow and divide. The disease can spread from the lungs to other parts of the body through the bloodstream or lymphatic system. This condition most commonly occurs in adults and can affect both smokers and non-smokers.

Trial ID:

2023-510463-35-00

Protocol code:

ETOP 22-22 ADEPPT

NCT ID:

NCT05673187

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of adagrasib in elderly patients (70 years or older) or patients with poor performance status who have KRAS G12C mutation-positive non-small cell lung cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?