Study Comparing Pembrolizumab and Lenvatinib with Docetaxel for Patients with Metastatic Non-Small Cell Lung Cancer After Previous Treatments

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as metastatic non-small cell lung cancer (NSCLC). This is a condition where cancer cells have spread from the lungs to other parts of the body. The study is comparing the effects of two different treatments. One treatment combines two medications: pembrolizumab (also known by its code name MK-3475) and lenvatinib (code name MK-7902). The other treatment uses a medication called docetaxel. Pembrolizumab is given as an infusion, which means it is delivered directly into the bloodstream through a vein, while lenvatinib is taken as a capsule by mouth. Docetaxel is also given as an infusion.

The purpose of the study is to compare how well these treatments work in helping patients live longer and in slowing down the progression of the cancer. Participants in the study will receive either the combination of pembrolizumab and lenvatinib or docetaxel. The study will monitor the participants over a period to see how the cancer responds to the treatments and to check for any side effects. The study aims to provide valuable information on which treatment might be more effective for patients who have already been treated with other therapies, including chemotherapy and immunotherapy.

Throughout the study, participants will undergo regular check-ups and tests to track their health and the status of their cancer. These tests may include imaging scans like MRI or CT scans, which help doctors see inside the body and assess the size and spread of the cancer. The study will also look at the quality of life of participants, considering factors like pain and physical functioning. This research is important for finding better ways to treat metastatic NSCLC and improve outcomes for patients with this challenging condition.

1 joining the study

Upon joining the study, participants will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment option.

2 treatment with pembrolizumab and lenvatinib

Participants in this group will receive a combination of two medications: pembrolizumab and lenvatinib.

Pembrolizumab is administered as an intravenous infusion, which means it is given through a vein. The infusion is done once every three weeks.

Lenvatinib is taken orally in the form of capsules. The dosage and frequency will be determined by the study team based on individual needs.

3 treatment with docetaxel

Participants in this group will receive docetaxel, which is also administered as an intravenous infusion. The infusion is typically given once every three weeks.

4 monitoring and follow-up

Throughout the study, participants will undergo regular monitoring to assess their health and the effectiveness of the treatment. This includes physical exams, blood tests, and imaging tests such as CT or MRI scans.

Participants will also be asked to complete questionnaires about their quality of life and any symptoms they may experience.

5 end of treatment

The treatment period will continue until the study ends, the disease progresses, or side effects become too severe. Participants will be informed about the next steps and any additional follow-up required.

Who Can Join the Study?

  • Has a confirmed diagnosis of metastatic squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c). Metastatic means the cancer has spread to other parts of the body. NSCLC stands for non-small cell lung cancer.
  • Has a life expectancy of at least 3 months.
  • Male participants must agree to either not have heterosexual intercourse or use contraception during the treatment and for a certain period after the last dose, depending on the medication received.
  • Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use contraception or not have heterosexual intercourse during the treatment and for a certain period after the last dose, depending on the medication received.
  • Has controlled blood pressure, defined as 150/90 mm Hg or lower, with or without medication, and no changes in blood pressure medication within 1 week before starting the study.
  • If the participant had major surgery or high-dose radiation therapy, they must have recovered from any side effects or complications.
  • Has adequate organ function, meaning the organs are working well enough to participate in the study.
  • Has PD (progressive disease) after treatment with one prior anti-PD-1/PD-L1 monoclonal antibody, which is a type of cancer treatment.
  • Has PD during or after platinum doublet chemotherapy for metastatic disease. Chemotherapy is a type of cancer treatment using drugs.
  • Has confirmation that certain targeted therapies (EGFR, ALK, or ROS1) are not suitable as primary treatment.
  • Has submitted imaging results showing evidence of PD after starting an anti-PD-1/PD-L1 inhibitor.
  • Has at least one measurable lesion (tumor) as seen on a CT or MRI scan, according to specific criteria.
  • Has provided a tumor tissue sample for PD-L1 biomarker analysis from a previous biopsy.
  • Has provided a new tissue sample from a biopsy done after completing immunotherapy and before starting the study.
  • Has an ECOG performance status of 0 or 1 within 7 days before the first dose of study treatment. This is a scale used to assess how a patient’s disease is progressing and how the disease affects their daily living abilities.

Who Cannot Join the Study?

  • Patients with a type of lung cancer called NSCLC (Non-Small Cell Lung Cancer) with either squamous or nonsquamous cell types cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Both male and female patients are considered for the study, but those who do not meet other criteria cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Comite Entreprise Paul Papin Angers France
Koranyi National Institute For Pulmonology Budapest Hungary
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Centre Hospitalier D Avignon Avignon France
University General Hospital Of Ioannina Ioannina Greece
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Centre Hospitalier Le Mans Le Mans France
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Scp Institut De Cancerologie Des Hauts De France Beuvry France
Farkasgyepui Tudogyogyintezet Farkasgyepu Hungary
Semmelweis University Budapest Hungary
Assistance Publique Hopitaux De Paris Paris France
SRH Wald-Klinikum Gera GmbH Gera Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Hospital Universitario De Jaen Jaen Spain
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet Szolnok Hungary
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hospital CUF Porto S.A. Porto Portugal
Thoracic General Hospital Of Athens I Sotiria Athens Greece
Metropolitan Hospital Athens Greece
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Iinvqw Iegvkplk Fmxyssudwwnkk Oiegjibeaff Rome Italy
Hjvtevwy Uyliywgacctso Mifjuzf Da Vssgazrqhv Santander Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
12.04.2019
Germany Germany
Not recruiting
12.04.2019
Greece Greece
Not recruiting
12.04.2019
Hungary Hungary
Not recruiting
12.04.2019
Italy Italy
Not recruiting
12.04.2019
Portugal Portugal
Not recruiting
12.04.2019
Spain Spain
Not recruiting
12.04.2019

Trial locations

Investigated drugs:

Pembrolizumab is a type of cancer treatment known as immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, pembrolizumab is used to treat patients with a type of lung cancer called non-small cell lung cancer that has spread to other parts of the body and has not responded to previous treatments.

Lenvatinib is a medication that helps to stop the growth of cancer cells by blocking certain proteins that cancer cells need to grow. It is used in combination with pembrolizumab in this trial to treat patients with metastatic non-small cell lung cancer, aiming to improve the effectiveness of the treatment.

Docetaxel is a chemotherapy drug that works by interfering with the growth and spread of cancer cells. In this trial, it is used as a comparison treatment to evaluate the effectiveness of the combination of pembrolizumab and lenvatinib in patients with metastatic non-small cell lung cancer who have not responded to previous treatments.

Investigated diseases:

Non-Small Cell Lung Cancer (NSCLC) – Non-Small Cell Lung Cancer is a type of lung cancer that includes several subtypes, such as squamous cell carcinoma and adenocarcinoma. It typically begins in the tissues of the lungs and can spread to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with normal lung function. Over time, these tumors may invade nearby tissues and organs. As the cancer advances, it can metastasize, meaning it spreads to distant parts of the body through the bloodstream or lymphatic system. The progression of NSCLC can vary greatly among individuals, depending on factors like the cancer’s subtype and stage at diagnosis.

Trial ID:
2022-501439-18-00
Protocol code:
MK-7902-008
Trial Phase:
Therapeutic confirmatory (Phase III)

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