Study on the Safety and Effectiveness of Sunvozertinib for Patients with Advanced Non-Small Cell Lung Cancer with EGFR or HER2 Mutations

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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). The study is investigating a new treatment called Sunvozertinib, also known by its code name DZD9008. This treatment is being tested on patients who have advanced stages of NSCLC with specific genetic changes, known as EGFR or HER2 mutations. These mutations are changes in the genes that can affect how cancer grows and responds to treatment.

The purpose of the study is to understand how safe and tolerable Sunvozertinib is for patients, as well as how effective it is in fighting the cancer. The study is divided into two parts. In the first part, researchers will focus on finding the best dose of Sunvozertinib that patients can take without experiencing severe side effects. In the second part, the study will look at how well the treatment works in shrinking or controlling the cancer in patients with a specific type of EGFR mutation called Exon20ins.

Participants in the study will take Sunvozertinib in the form of a tablet, which is taken by mouth. Throughout the study, researchers will monitor the patients closely to see how their bodies respond to the treatment and to check for any side effects. The study aims to provide valuable information that could lead to new treatment options for patients with advanced NSCLC who have these specific genetic mutations.

1 joining the study

Upon joining the study, the patient will be required to provide a signed and dated informed consent form. This is necessary before any study-specific procedures, sampling, or analyses can begin.

2 phase I: dose escalation

In this phase, the patient will receive the medication Sunvozertinib orally in the form of a tablet. The purpose is to investigate the safety and tolerability of the medication in patients with advanced non-small cell lung cancer (NSCLC) with specific mutations.

The goal is to establish the maximum tolerated dose and the recommended dose for the next phase of the study.

3 phase I: dose expansion

Patients will continue to receive Sunvozertinib orally. This phase involves expanding the number of patients to further assess the safety and preliminary anti-tumor efficacy of the medication.

Patients with specific genetic mutations who have relapsed or are intolerant to prior therapies will be included.

4 phase II: anti-tumor activity evaluation

In this phase, the focus is on evaluating the anti-tumor activity of Sunvozertinib at defined doses. The objective response rate, which measures the percentage of patients whose cancer shrinks or disappears after treatment, will be assessed.

Patients will continue to take the medication orally as prescribed.

5 monitoring and assessments

Throughout the study, patients will undergo regular monitoring to assess the safety and effectiveness of the treatment. This includes checking for any adverse events or side effects.

Blood samples may be taken to measure the concentration of the medication in the plasma, and other tests may be conducted to evaluate the patient’s response to the treatment.

6 completion of the study

The study is estimated to end by December 2025. Upon completion, the data collected will be analyzed to determine the overall safety and efficacy of Sunvozertinib in treating advanced NSCLC with specific mutations.

Who Can Join the Study?

Patients must be able to understand the nature of the trial and provide a signed and dated written informed consent form before any study-specific procedures, sampling, and analyses.
Patients must be at least 18 years old.
Patients must have a confirmed diagnosis of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). This means the cancer has spread beyond the lungs.
Patients must have a specific genetic change called EGFR Exon20ins mutation in their tumor, confirmed by a certified laboratory.
Patients should have received at least 1, but no more than 3, previous treatments for their advanced cancer.
Patients must have a good general health status, as measured by the Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which indicates they are fully active or have some symptoms but do not require bed rest.
Patients must have a predicted life expectancy of at least 12 weeks.
Patients must have measurable disease according to specific criteria called RECIST 1.1, which is a way to measure how the cancer responds to treatment.
Patients with brain metastasis (cancer spread to the brain) can participate only if the brain metastasis has been treated, is stable, and does not cause symptoms or require steroid treatment.
Patients must have adequate organ function, meaning their vital organs like the liver and kidneys are working well enough.
For Part A of the study (Phase I), patients must have a confirmed diagnosis of NSCLC with EGFR or HER2 mutations and have not responded to or cannot tolerate previous standard treatments.
For Part B of the study (Phase II), patients must have a confirmed diagnosis of NSCLC with EGFR Exon20ins mutation and have not responded to or cannot tolerate at least one previous treatment.
Patients who have not received any prior treatment for their NSCLC can also participate in certain parts of the study.
Patients who have previously received a treatment called Amivantamab and did not respond or could not tolerate it can participate in certain parts of the study.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Non-Small Cell Lung Cancer.
Patients who do not have specific genetic changes called EGFR or HER2 mutations in their cancer.
Patients who are not within the specified age range for the study.
Patients who are not able to take the study medication by mouth.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had certain treatments recently that might affect the study results.
Patients who have allergies to the study medication or its ingredients.
Patients who have a history of not following medical advice or treatment plans.

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
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Centr Georges Francois Leclerc	Dijon	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Awgytjx Odzvfctvtcw Uhbfewldmbkto Prylj	Parma	Italy
Atbzlznada Pexqdwcq Hcgzacfj Da Mrcxqjwhy	Marseille	France
Iypscfsr Casajr Dpqshxuqfbfwatdlo	L'hospitalet De Llobregat	Spain
Ffezghghc Pevg Ls Ibizwjhuwwdgb Brnsazpvh Dao Hszyywxh Udeldgwtuezsv Li Pst	Madrid	Spain
Hkfiktvv Vkmv dnndmjye	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	04.10.2021
Italy	Not recruiting	04.10.2021
Spain	Not recruiting	04.10.2021

Trial locations

Investigated drugs:

Sunvozertinib

DZD9008 is an investigational medication being studied for its potential to treat advanced non-small cell lung cancer (NSCLC) in patients who have specific mutations in the EGFR or HER2 genes. This medication is taken orally and is being evaluated for its safety, how well patients can tolerate it, and its effectiveness in reducing tumor size. The study aims to determine the best dose to use in future research and to see how well it works in shrinking tumors in patients with these specific genetic mutations.

Investigated diseases:

Non-small cell lung cancer

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms. The progression and impact of the disease can vary based on the specific subtype and stage at diagnosis.

Trial ID:

2024-512127-36-00

Protocol code:

DZ2019E0001

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Sunvozertinib for Patients with Advanced Non-Small Cell Lung Cancer with EGFR or HER2 Mutations

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?