Study of Amivantamab and Lazertinib Combination vs. Osimertinib vs. Lazertinib for First-Line Treatment in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying treatments for . This type of lung cancer is characterized by specific changes in the gene, which can affect how cancer cells grow and spread. The study will compare different treatments to see which is most effective as a first-line treatment, meaning it is the first treatment given for this condition.

The treatments being studied include a combination of two medications, and , as well as and Lazertinib on their own. Amivantamab is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein. Lazertinib and Osimertinib are taken as tablets by mouth. The purpose of the study is to assess how well these treatments work in patients with this specific type of lung cancer.

Participants in the study will receive one of these treatments and will be monitored over time to see how their cancer responds. The study will help determine which treatment is most effective in managing the disease. This information could be valuable for future treatment decisions for patients with .

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Blood tests and imaging scans are performed to establish a baseline for comparison throughout the trial.

2 treatment assignment

Participants are randomly assigned to one of three treatment groups: amivantamab and lazertinib combination therapy, osimertinib, or lazertinib alone.

The assignment is done to compare the effectiveness of these treatments in patients with specific genetic mutations in their lung cancer.

3 treatment administration

For those receiving amivantamab, the medication is administered through an intravenous infusion. The frequency and duration of these infusions are determined by the study protocol.

Participants taking lazertinib or osimertinib receive the medication orally in tablet form. The dosage and frequency are specified by the study guidelines.

4 regular monitoring

Throughout the trial, regular monitoring is conducted to assess the response to treatment. This includes periodic blood tests, imaging scans, and physical examinations.

Participants are required to report any side effects or changes in health to the study team.

5 follow-up assessments

Follow-up assessments are scheduled at specific intervals to evaluate the long-term effects of the treatment.

These assessments help determine the progression of the disease and the overall effectiveness of the treatment.

6 end of study

The study is estimated to conclude by June 2027. At the end of the study, a final assessment is conducted to gather comprehensive data on the treatment outcomes.

Participants may be offered continued access to the treatment if it is deemed beneficial and safe.

Who Can Join the Study?

Participant must be at least 18 years old or the legal age of consent in the area where the study is conducted.
A woman who can have children must have a negative pregnancy test before starting the study and agree to regular pregnancy tests during the study.
A woman must either not be able to have children or agree to use effective birth control methods during the study and for 6 months after the last dose of the study treatment.
A woman must agree not to donate eggs for reproduction during the study and for 6 months after the last dose of the study treatment.
A man must use a condom during any activity that could result in pregnancy during the study and for 6 months after the last dose of the study treatment. If sexually active with a woman who can have children, his partner must also use effective birth control.
A man must agree not to donate sperm for reproduction during the study and for 6 months after the last dose of the study treatment.
Participant must be willing and able to follow the lifestyle restrictions required by the study.
Participant must have a newly diagnosed, confirmed case of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that has not been treated and cannot be cured with surgery or combined chemotherapy and radiation.
The tumor must have specific genetic changes called Exon 19del or Exon 21 L858R substitution, confirmed by a test approved by the FDA or another validated test.
Participant must provide a sample of the tumor tissue and blood for analysis.
Any side effects from previous cancer treatments must have improved to a mild level or returned to the level before treatment.
Participant must have at least one measurable tumor that has not been treated with radiation. If only one measurable tumor exists, it can be biopsied for diagnosis if necessary.
Participant must have proper functioning of organs and bone marrow without recent blood transfusions or treatments to boost blood cell production.
Participant must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1, which indicates they are fully active or have some symptoms but do not need bed rest.
Participant must sign a consent form indicating they understand the study’s purpose and procedures and agree to participate.

Who Cannot Join the Study?

Patients who do not have a specific type of lung cancer called EGFR-mutated Non Small Cell Lung Cancer cannot participate.
Patients who do not have the specific genetic changes known as Exon 19del or Exon 21 L858R substitution in their cancer cannot participate.
Patients who are not in the age range specified for the study cannot participate.
Patients who are not part of the clinical trial group specified for the study cannot participate.
Patients who are considered part of a vulnerable population, which means they might need special protection, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Universitaire De Lille	Lille	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Institut Curie – Site Paris	Paris	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz	Szekesfehervar	Hungary
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
Med Polonia Sp. z o.o.	Poznan	Poland
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Robert Bosch Krankenhaus GmbH	Stuttgart	Germany
Zentralklinik Bad Berka GmbH	Bad Berka	Germany
Jeroen Bosch Ziekenhuis Stichting	S-Hertogenbosch	The Netherlands
HELIOS Klinikum Emil von Behring GmbH	Berlin	Germany
Grand Hopital De Charleroi	Charleroi	Belgium
Ziekenhuis St Jansdal	Harderwijk	The Netherlands
Hjclbrqc Vrro dpohuioo	Barcelona	Spain
Hroobjdg Uwgkwxcuobezh de A Cogaig	A Coruna Galicia	Spain
Iuwqrvmp Rybqhqavz Pym Ln Seofrh Dpw Tobbxy Dsmp Awbjdgq Iemq Smegxb	Meldola	Italy
Aswdlpwsaq Prymlsor Hctumfwz Da Mipzekczi	Marseille	France
Ciwkqa Hvgpejtvdgx Rgvwlpwn Udgkinhloheon Dx Tbkwz	Tours	France
Hbvtdmzh Dz Le Sropt Cfol I Sjiq Pqq	Barcelona	Spain
Uwopilsmbegmosyqqziao Eiijo Ajx	Essen	Germany
Inesjemg Clpyqs Dzzmhccnblkargxyl	L'hospitalet De Llobregat	Spain
Frybrpcwb Pjne Ln Iafzbbilqgevb Binisqjaf Dux Hrwnbriq Uikrzcdkbvdsz Lk Pzd	Madrid	Spain
Sdkygtnkt Rqzuqpq Upykocvlom Mcvvxca Cvpxkl	Nijmegen	The Netherlands
Nqkwxtnz Igbmrhig Oidvmrrnm Ibh Mctmi Sffrhyctklguivmumnuldsjrqukd Ihploldh Blfaxmfk	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	05.01.2020
France	Not recruiting	05.01.2020
Germany	Not recruiting	05.01.2020
Hungary	Not recruiting	05.01.2020
Italy	Not recruiting	05.01.2020
Poland	Not recruiting	05.01.2020
Portugal	Not recruiting	05.01.2020
Spain	Not recruiting	05.01.2020
The Netherlands	Not recruiting	05.01.2020

Trial locations

Investigated Drugs:

Amivantamab is a medication used in this trial to treat patients with a specific type of lung cancer. It works by targeting and blocking certain proteins on cancer cells, which can help slow down or stop the growth of the cancer.

Lazertinib is another medication involved in the trial. It is used to treat lung cancer by specifically targeting and inhibiting the activity of proteins that are involved in the growth and spread of cancer cells.

Osimertinib is a medication used in the trial as a comparison to the combination of amivantamab and lazertinib. It is designed to target and block specific proteins in cancer cells, helping to control the growth of the cancer.

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. The disease can be locally advanced, meaning it has spread to nearby tissues or lymph nodes, or metastatic, indicating it has spread to other parts of the body. A specific mutation in the EGFR gene can drive the growth of cancer cells in some cases. This mutation can affect how the disease progresses and responds to certain treatments.

Trial ID:

2023-506576-27-00

Protocol code:

73841937NSC3003

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Amivantamab and Lazertinib Combination vs. Osimertinib vs. Lazertinib for First-Line Treatment in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?