Study of Amivantamab, Lazertinib, and Drug Combination for Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer After Osimertinib Failure

3 1 1 1

What is this study about?

This clinical trial is focused on studying treatments for , a type of lung cancer that has specific changes in the gene. The study is looking at how well a combination of medications works compared to standard treatments. The medications being tested include and , which are being used together with . The chemotherapy involves drugs like and . These treatments are being compared to the usual chemotherapy with carboplatin and pemetrexed alone.

The purpose of the study is to see if the combination of amivantamab and lazertinib with chemotherapy is more effective than chemotherapy alone in patients whose cancer has worsened after treatment with a drug called . Participants in the study will receive either the combination treatment or the standard chemotherapy. The study will last for a period of time, during which participants will receive their assigned treatment and be monitored regularly to assess the effects of the treatment on their cancer.

Throughout the study, participants will receive their treatments either as an infusion, which is a way of delivering medication directly into the bloodstream through a vein, or as tablets taken by mouth. The study aims to provide more information on the effectiveness of these treatments and help improve future care for patients with this type of lung cancer.

1 joining the study

Upon joining the study, the participant will be randomly assigned to one of two treatment groups. This assignment is done to compare the effectiveness of different treatment combinations.

2 treatment group assignment

Participants will be assigned to either the combination of amivantamab and lazertinib with platinum-based chemotherapy or to platinum-based chemotherapy alone. The specific treatment plan will depend on the group assignment.

3 treatment administration

For those receiving amivantamab and lazertinib with chemotherapy, amivantamab is administered intravenously, and lazertinib is taken orally. The chemotherapy includes carboplatin and pemetrexed, both given intravenously.

Participants in the chemotherapy-only group will receive carboplatin and pemetrexed intravenously.

4 treatment schedule

The treatment cycle is repeated every 21 days. The duration of the treatment will depend on the participant’s response and any side effects experienced.

5 monitoring and assessments

Regular monitoring will occur throughout the study to assess the participant’s health and the effectiveness of the treatment. This includes physical exams, blood tests, and imaging studies.

6 end of treatment

The treatment will continue until the disease progresses, unacceptable side effects occur, or the participant decides to stop. After treatment ends, follow-up visits will be scheduled to monitor the participant’s health.

Who Can Join the Study?

  • Must be at least 18 years old or the legal age of consent in the area where the study is conducted.
  • Must have a confirmed diagnosis of a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC), with certain genetic changes known as EGFR Exon 19del or Exon 21 L858R mutation.
  • Must have previously been treated with a medication called osimertinib and shown disease progression after this treatment.
  • Must have at least one tumor that can be measured and has not been treated with radiation.
  • If there is a history of cancer spreading to the brain, all brain lesions must have been treated, and no further treatment should be needed at the time of joining the study.
  • Must have a general health status that allows for normal daily activities, classified as ECOG status 0 or 1.
  • Must have adequate function of organs and bone marrow, which includes specific levels of blood cells and liver and kidney function.
  • Any side effects from previous cancer treatments must have improved to a mild level or returned to the state before treatment, except for hair loss, mild nerve damage, or mild thyroid issues that are stable with medication.
  • Must agree to sign a document confirming understanding of the study and willingness to participate.
  • Must agree to use a condom during sexual activity to prevent the transfer of treatment effects to others and avoid donating sperm for reproduction during the study and for six months after the last treatment dose.
  • If able to become pregnant, must have a negative pregnancy test before starting the study and agree to regular pregnancy tests during the study.
  • If able to become pregnant, must agree to use effective birth control methods during the study and for six months after the last treatment dose.
  • Must agree not to donate eggs for reproduction during the study and for six months after the last treatment dose.
  • Must be willing to follow specific lifestyle guidelines provided in the study protocol.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than the specific lung cancer being studied.
  • Patients who have not been diagnosed with the specific genetic changes in their cancer that the study is focusing on.
  • Patients who are not within the age range specified for the study.
  • Patients who are unable to follow the study procedures or take the study medications as required.
  • Patients who have other serious health conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had certain treatments recently that might interfere with the study results.
  • Patients who have allergies or reactions to the study medications or similar drugs.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment Sofiamed OOD Sofia Bulgaria
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Grand Hopital De Charleroi Charleroi Belgium
Hospital Beatriz Angelo Loures Portugal
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Ziekenhuis St Jansdal Harderwijk The Netherlands
Nemocnice AGEL Ostrava-Vitkovice a.s. Ostrava Czechia
Med Polonia Sp. z o.o. Poznan Poland
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
Centre Hospitalier Le Mans Le Mans France
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Jessa Ziekenhuis Hasselt Belgium
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Rigshospitalet Copenhagen Denmark
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Icfigj Iiaxibwm Fpcczkqpyuhmw Odjbqaspwfb Rome Italy
Ibyeuciy Rqygcxgcm Pkm Lg Swfxio Dla Txrahm Dgpy Awklzrw Ijuo Swamdq Meldola Italy
Aeyhtwuqe Uxa Amsterdam The Netherlands
Ayflvkgvht Pjpsyczm Hwvlfxlk Dm Msjikzmbd Marseille France
Ugjzbes Uvbbkvcfjw Hdvafbum Uppsala Sweden
Ezxgpfs Upkijwbdkdvq Mfwoyrt Ctqcoxk Recohgfap (lgdrhhy Mqy Rotterdam The Netherlands
Nkjpjysz Ikqtmhva Obtccbiuu Ibl Mykqo Skfamjiwdctneavtscigcacvqlto Irhmocmo Bybvgufl Cracow Poland
Ukwqkzzbdydokq Cuaetsp Kaajkxxas Gdansk Poland
Hkgfqozv Dw Ls Swcwv Csce I Sgmq Pzk Barcelona Spain
Uwpnjwpkea Ou Aartemj Edegem Belgium
Hcfjqjhw Vdgj dlwslnpm Barcelona Spain
Hpanwahu Uebcakbhirvgs dp A Cgjvhp A Coruna Galicia Spain
Htlfyavs Ulnjljtebhaxji Sdynryazvh &dliirv Hxjnaux dd Hueitkdgubs STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.11.2021
Bulgaria Bulgaria
Not recruiting
01.11.2021
Czechia Czechia
Not recruiting
01.11.2021
Denmark Denmark
Not recruiting
01.11.2021
France France
Not recruiting
01.11.2021
Germany Germany
Not recruiting
01.11.2021
Italy Italy
Not recruiting
01.11.2021
Poland Poland
Not recruiting
01.11.2021
Portugal Portugal
Not recruiting
01.11.2021
Spain Spain
Not recruiting
01.11.2021
Sweden Sweden
Not recruiting
01.11.2021
The Netherlands The Netherlands
Not recruiting
01.11.2021

Trial locations

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 included in the trial. It is designed to target and inhibit specific proteins that are involved in the growth and spread of cancer cells, particularly in patients who have a mutation in the EGFR gene.

Carboplatin is a type of chemotherapy used in the trial. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. This can help to shrink tumors and slow the progression of the disease.

Pemetrexed is also a chemotherapy drug used in the study. It interferes with the cancer cell’s ability to use folate, a vitamin that is necessary for cell division. By doing so, it can help to stop the growth of cancer cells.

Investigated diseases:

Locally Advanced or Metastatic Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its spread beyond the original site. It is classified as “locally advanced” when it has spread to nearby tissues or lymph nodes but not to distant body parts. When it becomes “metastatic,” it means the cancer has spread to other organs or distant parts of the body. The disease often progresses through stages, starting from localized tumors to more widespread involvement. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression can vary, with some cases advancing more rapidly than others.

Trial ID:
2023-506518-33-00
Protocol code:
61186372NSC3002
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of MK-1084 plus durvalumab in patients with locally advanced unresected KRAS G12C‑mutated non‑small cell lung cancer after chemoradiotherapy

    Recruiting

    3 1 1
    Investigated drugs:
    France Germany Greece Italy The Netherlands Poland +1
  • Zongertinib with cisplatin or carboplatin and pemetrexed, with or without pembrolizumab, for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations

    Recruiting

    2 1 1 1
    Investigated diseases:
    France Germany Spain