Study on the Safety and Effects of STX-241 for Patients with Advanced Non-Small Cell Lung Cancer Resistant to EGFR Inhibitors

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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 become resistant to certain treatments called EGFR tyrosine kinase inhibitors (TKIs). The trial is testing a new oral medication called STX-241, which is a film-coated tablet designed to treat this advanced form of lung cancer. The purpose of the study is to learn about the safety and effects of STX-241 in patients with this specific type of lung cancer.

The study is divided into three parts. In the first part, researchers will focus on understanding how safe and tolerable STX-241 is for patients, as well as determining the right dose to use in the next phase. The second part will continue to assess safety and will aim to find the best dose to recommend for further testing. The third part will look at how effective STX-241 is at treating the cancer when given at the recommended dose. Throughout the study, participants will take the medication orally and will be monitored for any side effects or changes in their condition.

Participants in the trial will have their health closely monitored, including regular check-ups and tests to track their response to the treatment. The study aims to provide valuable information on the potential benefits and risks of using STX-241 for treating advanced NSCLC, which could lead to new treatment options for patients with this challenging condition.

1 joining the study

Upon joining the study, participation begins in a clinical trial designed to evaluate the safety and effects of a new oral anticancer drug called STX-241.

The trial is intended for individuals with advanced lung cancer that is resistant to certain treatments.

2 part 1: safety and dose determination

In this initial phase, the focus is on understanding the safety and how well STX-241 is tolerated.

Participants will receive STX-241 in the form of a film-coated tablet taken orally.

The goal is to identify the range of doses that can be used in the next phase, including the optimal dose and the maximum dose that can be tolerated.

3 part 2: recommended dose and further safety assessment

This phase aims to determine the recommended dose for future studies.

Participants will continue to take STX-241 orally, and the safety and tolerability will be further evaluated.

The effects of the drug on the cancer will also be assessed.

4 part 3: efficacy evaluation

In the final phase, the effectiveness of STX-241 at the recommended dose is investigated.

Participants will continue the oral administration of the drug.

The primary focus is on how well the drug works in treating the cancer.

Who Can Join the Study?

The patient must have a confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR mutations (ex19del or L858R mutations). The cancer should be at Stage IIIB/C or IV, which means it is advanced and cannot be treated with surgery or combined treatments aimed at curing it.
For Parts 1 and 2 of the study, the patient’s disease must have worsened after receiving a specific type of treatment called 3rd generation EGFR TKI-based therapy. This could have been given alone or with other treatments at any time before. For Part 3, the disease must have worsened after this therapy was given as the last treatment.
The patient must have a specific tumor mutation profile. For Parts 1 and 2, this means having a mutation called C797X and not having a mutation called T790M, confirmed by tests done as part of regular medical care. For Part 3, these mutations must be confirmed by a central test before joining the study.
For Part 1 (backfilling component) and Parts 2 & 3, the patient must have at least one measurable target lesion. This means there is a tumor that can be measured to see if it changes in size during the study, according to specific guidelines called RECIST v1.1.
The patient must have an ECOG performance status of 0-1. This is a scale used to assess how well a patient can perform daily activities, with 0 meaning fully active and 1 meaning some restrictions but still able to do light work.
The patient must have adequate hematologic function, which means their blood tests must meet certain criteria specified in the study protocol.
The patient must have adequate cardiac function, meaning their heart health must meet specific criteria outlined in the study protocol.
The study is open to both male and female patients.
The study includes patients who are considered part of a vulnerable population.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have not shown resistance to EGFR tyrosine kinase inhibitors (TKIs). These are specific medications used to treat certain types of lung cancer.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medication or its ingredients.
Patients who have a history of certain medical conditions that the study excludes.

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
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Netherlands Cancer Institute	Amsterdam	The Netherlands
Hospital Quironsalud Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Ckaxrp Lpgo Bfeiwt	Lyon	France
Fbvaxtqjj Pivj La Iqmpcfrkmhivq Bkxzceiql Diu Hdjozgii Uugnbeigxjbgk Lv Pok	Madrid	Spain
Hjjolpst Vekn dqpmjlij	Barcelona	Spain
Aufn &tkhiss Hioqbkg Du Lq Tgwhmx &ovyecd Dsmzeljzcodwl Vtqokupwbyhq Ex	Marseille	France
Kbroetmh dpw Uicvyppbyunf Melzvkvc Arj	Munich	Germany

Trial status

Country	Status	Recruitment Start
France	Recruiting	11.09.2024
Germany	Recruiting	11.09.2024
Spain	Recruiting	11.09.2024
The Netherlands	Recruiting	11.09.2024

Trial locations

Investigated Drugs:

Stx-241

STX-241 is an investigational medication being studied for its safety and effectiveness in treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is resistant to EGFR tyrosine kinase inhibitors (TKIs). The trial aims to determine the appropriate dosage and assess how well patients tolerate the medication. Additionally, the study will evaluate the medication’s ability to treat this type of lung cancer effectively.

Non-Small Cell Lung Cancer (NSCLC) – 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 tissues of the lung. NSCLC is known for its slower progression compared to small cell lung cancer. In its locally advanced or metastatic form, the cancer has spread beyond the lungs to other parts of the body. Resistance to EGFR tyrosine kinase inhibitors (TKIs) can occur, making treatment more challenging. The disease may cause symptoms like persistent cough, chest pain, and difficulty breathing as it progresses.

Trial ID:

2023-510203-21-00

Protocol code:

F60087CI101

NCT ID:

NCT06567015

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Effects of STX-241 for Patients with Advanced Non-Small Cell Lung Cancer Resistant to EGFR Inhibitors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?