Study Comparing MK-2870 with Chemotherapy (Docetaxel or Pemetrexed) for Patients with Advanced Non-Small Cell Lung Cancer with EGFR 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), specifically in patients who have certain genetic changes, such as EGFR mutations. The study is comparing a new treatment called MK-2870 with standard chemotherapy options, which include drugs like Docetaxel and Pemetrexed. These treatments are used for patients whose cancer has advanced or spread to other parts of the body after previous treatments.

The purpose of the study is to see how well MK-2870 works compared to the chemotherapy drugs in terms of slowing down the cancer and improving survival. Participants will receive either MK-2870 or one of the chemotherapy drugs, and some may receive a placebo. The study will involve regular check-ups and assessments to monitor the cancer’s response to the treatment.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. The study aims to provide valuable information on the effectiveness and safety of MK-2870 as a potential treatment option for patients with advanced NSCLC who have specific genetic changes. This research could lead to new insights and improvements in the treatment of this type of lung cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments.

Participants must have advanced or metastatic non-small cell lung cancer with specific genetic mutations.

2 randomization

Participants are randomly assigned to receive either the experimental drug MK-2870 or standard chemotherapy.

The chemotherapy options include docetaxel or pemetrexed, administered through intravenous infusion.

3 treatment administration

If assigned to the MK-2870 group, the drug is administered as a powder for solution for injection.

For those receiving chemotherapy, docetaxel or pemetrexed is given through intravenous infusion according to the standard dosing schedule.

4 monitoring and assessments

Regular monitoring is conducted to assess the progression of the disease and the participant’s overall health.

Assessments include imaging tests and evaluations based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

5 evaluation of outcomes

The primary outcomes measured are progression-free survival and overall survival.

Secondary outcomes include response rates, duration of response, and changes in quality of life scores.

6 completion of study

The study is estimated to conclude by March 2030.

Participants will be informed of the study results and any potential implications for their treatment.

Who Can Join the Study?

  • Have advanced or metastatic non-squamous Non-small Cell Lung Cancer (NSCLC) with specific mutations. This means the cancer is in a stage that cannot be removed by surgery or cured with radiation.
  • Have an ECOG performance status of 0 or 1. This is a scale that measures how well you can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to do light work.
  • Show proof of disease progression based on specific criteria called RECIST 1.1 after the last treatment.
  • If you have certain genetic mutations, you must have received 1 or 2 prior treatments with a type of medication called EGFR TKI, and a specific third-generation TKI if you have a T790M mutation. You must also have had one treatment with platinum-based therapy after the disease progressed on or after EGFR TKI.
  • Be at least 18 years old at the time of giving consent to participate.
  • Have a measurable disease according to RECIST 1.1 as determined by the local investigator.
  • Provide a sample of tumor tissue, either from a previous biopsy or a new one, from a tumor that has not been treated with radiation.
  • If you have side effects from previous cancer treatments, they must have improved to a mild level or returned to the level they were before treatment.
  • If you have hepatitis B, you must have been on antiviral therapy for at least 4 weeks and have an undetectable viral load before starting the trial.
  • If you are HIV-positive, your HIV must be well controlled with antiretroviral therapy (ART).

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Non-small Cell Lung Cancer (NSCLC) cannot participate.
  • Patients without EGFR mutations in their cancer cells are not eligible. EGFR mutations are changes in a gene that can affect how cancer grows.
  • Patients who are not within the specified age range for the study cannot join. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
IRCCS Humanitas Research Hospital Rozzano Italy
Universitaetsmedizin Goettingen Goettingen Germany
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Centre Hospitalier Universitaire Rouen Rouen France
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Hospital General Universitario Gregorio Maranon Madrid Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Henry Dunant Hospital Center Athens Greece
Nemocnice AGEL Ostrava-Vitkovice a.s. Ostrava Czechia
Fakultni Nemocnice Plzen Plzen Czechia
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Hospital Clinic De Barcelona Barcelona Spain
Klinikum Chemnitz gGmbH Chemnitz Germany
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
INSTYTUT GRUŹLICY I CHORÓB PŁUC Warsaw Poland
Cnangk Lezx Bfhttx Lyon France
Iuxdtz Iifutucx Fpcnqeiwtusvr Oalbdwizmbu Rome Italy
Hoyqoikg Ujnszhbowahen Reuzmulg Dq Mpfmvz Malaga Spain
Tbumvhzwdu Clznlu Hntpgiud Thessaloniki Greece
Ltrdw Gjvplzs Hytkhkgh Os Aolmfn Athens Greece
Imvektfw Brcblvfw Bordeaux France
Invwnlol Recipdnrp Pxn Lt Sjnqwo Dms Tanxzi Dnzz Afhsvoi Idbr Samvrs Meldola Italy
Nqvdlony Ivzhrguh Odcneoolw Ipm Mejmr Srbsrefddalibmqzmzslrkboqnjh Iyldrxcq Bstdvnnh Cracow Poland
Agxvxwy Hsilwjxq Athens Greece
Gffrzz Hbzrhyucnqr Uzgdhbcihdniq Pzlva Pwpzohgrdts Ep Nsbsetjqhkwn Paris France
Kugdgyqs Eqmedcaswkkbkganabewtfcj Hjjgcnvotspjfhdgn Essen Germany
Hfjdxahw Veet dbxihdee Barcelona Spain
Wpazigwppq Sefgiao Ibo Susmnyp Phs W Pdsteenjr Przemysl Poland
Ujyukttmvk Gsavrvl Hhgxlfxl Afcbvys Athens Greece
Ijmgsnpb Cfbbu Paris France

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
01.07.2024
France France
Not recruiting
01.07.2024
Germany Germany
Not recruiting
01.07.2024
Greece Greece
Not recruiting
01.07.2024
Italy Italy
Not recruiting
01.07.2024
Poland Poland
Not recruiting
01.07.2024
Spain Spain
Not recruiting
01.07.2024

Trial locations

MK-2870 is an investigational medication being studied for its effectiveness in treating advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with specific genetic changes, such as EGFR mutations. The trial aims to see how well this medication works compared to standard chemotherapy treatments.

Docetaxel is a type of chemotherapy used in this study as a comparison to MK-2870. It works by interfering with the growth of cancer cells, slowing or stopping their spread in the body.

Pemetrexed is another chemotherapy option used in the trial. It helps to block the growth of cancer cells by interfering with their ability to use folic acid, which is necessary for their growth and survival.

Non-small Cell Lung Cancer (NSCLC) – This is the most common type of lung cancer, accounting for about 85% of all cases. It typically starts in the epithelial cells lining the lungs and can grow and spread to other parts of the body. NSCLC is often categorized into subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, based on the type of cells affected. The disease progresses through stages, from localized tumors to more advanced stages where cancer has spread to lymph nodes or other organs. Symptoms may include a persistent cough, chest pain, and difficulty breathing, but they often appear only after the disease has advanced. The progression and symptoms can vary significantly depending on the specific genetic mutations present, such as those affecting the epidermal growth factor receptor (EGFR).

Trial ID:
2023-503539-16-00
Protocol code:
MK2870-004
NCT ID:
NCT06074588
Trial Phase:
Therapeutic confirmatory (Phase III)

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