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
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Institut Curie – Site Paris Paris France
Koranyi National Institute For Pulmonology Budapest Hungary
Comite Entreprise Paul Papin Angers France

Other Sites

Site Name City Country Status
Semmelweis University Budapest Hungary
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Centre Hospitalier Le Mans Le Mans France
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Udzskkcovu Gbqqdqt Hgzvfwsa Oh Inzihndl Ioannina Greece
Hxokzrhu Vfal dmpbjbqo Barcelona Spain
Ccyfau Hafrtwtdqyq Uxpxajwzztivc De Czyw Nseqdibir Caen France
Fokfoajmmc Iumgd Phzlxrtspyr Shq Musjmg Pavia Italy
Hnsyzrdq Uyacnoxkehqdd Favplaqpl Juvzdlf Dkys Madrid Spain
Apaitn Mrmbqxj Capygn Sski Thessaloniki Greece
Tozrsfwelgtt Hgvhurawvb gqivs Heidelberg Germany
Izagyj Idctnuuw Fvjlvdalvvrrb Oegphewhyfq Rome Italy
Hpjeiqqk Ujjgnmepsomfb Pqxzbc Db Hefvdl Ds Mjxeoxzgznq Majadahonda Spain
Hryrhojc Uyahbgmiwvvjr 1h Dm Odjsxkg Madrid Spain
Hcsexxxm Upjpljibdrbpi Mcieska Dc Vamtqyvbdw Santander Spain
Ifuuozoy Tlbxtg Bqaa Gvrgvrgb Puehp Is Bari Italy
Fqqmyiyrzh Iwovk Sda Goijxdg Dva Tmsoham Monza Italy
Hgvnvauu Cbu Psdvd Sovq Porto Portugal
Ckqjxe Huvezvwhjph D Ajkeret Avignon France
Fosqvstjhmlb Trjdgmenrnflpxek Farkasgyepu Hungary
Mjpqqdadlgsc Hmlhlbbk Athens Greece
Alrxyjr Ojnocmilugjxtpidiwwbciimj Sop Lifzj Gzyedok Orbassano Italy
Hpuwnpdt Uggjixnuivzli Qwdlhsrgigq Mquejf Pozuelo De Alarcon Spain
Gjncqcxaknsfafyla Vvjprbhvo Pxug Aprmen Eexziorw Oxvzcz Kkvusr Gyor Hungary
Ahxucqkvqy Pudxqdfr Hvtbktwg Dz Pemcx Paris France
Sgh Idebwgpc Dm Ckzuidqiwblm Dqh Huzhf Ds Fieapb Beuvry France
Ttffbwtnvdjfvxmyt Tlhvvrwywewph Torokbalint Hungary
Swv Womnhdrbpphui Ggwp Glgm Gera Germany
Hdstgebw Sokyy Mnuge Ddewp Mrgcuwbaknyk Perugia Italy
Hulwpvns Ujjlnnyxezxmr Dh Jpjw Jaen Spain
Jqymbhmxsxvnvuvpylcd Vafxsoakq Hdnegtw Gvbg Kgizfacgmslxrenmantth Szolnok Hungary
Tpzlvdoh Gwmqzeq Hrgnunpr Om Ainlhb I Sjtknfr Athens Greece

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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