Study of Pembrolizumab, Olaparib, and Pemetrexed for Patients with Stage IV Non-Small Cell Lung Cancer

3 1 1 1

What is this study about?

This clinical trial is focused on studying treatments for metastatic non-squamous non-small-cell lung cancer (NSCLC), which is a type of advanced lung cancer. The study involves several medications, including Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin, and Olaparib. Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system fight cancer. Olaparib, with the code name MK-7339, is a medication that targets cancer cells directly. Pemetrexed, Carboplatin, and Cisplatin are chemotherapy drugs that help stop the growth of cancer cells.

The purpose of this study is to compare the effectiveness of different treatment combinations in improving the survival of patients with this type of lung cancer. Participants will receive a combination of Pembrolizumab with either Pemetrexed and a platinum-based drug (Carboplatin or Cisplatin) or Olaparib. After the initial treatment phase, participants will continue with either Olaparib or Pemetrexed as maintenance therapy. Some participants may receive a placebo during the maintenance phase to help researchers understand the effects of the medications better.

The study will take place over several months, with regular check-ups and assessments to monitor the participants’ health and the cancer’s response to the treatment. The goal is to determine which combination of treatments offers the best outcomes in terms of slowing down the progression of the cancer and improving overall survival. Participants will be closely monitored for any side effects or changes in their condition throughout the study.

1 induction phase

The induction phase involves the administration of pembrolizumab in combination with either carboplatin or cisplatin and pemetrexed. These medications are given through an intravenous infusion.

The purpose of this phase is to initiate treatment for metastatic non-squamous non-small-cell lung cancer (NSCLC).

2 maintenance phase

Following the induction phase, the maintenance phase begins. This phase involves continued treatment with pembrolizumab and either olaparib or pemetrexed.

Olaparib is administered orally in the form of film-coated tablets. The specific dosage and frequency will be determined by the healthcare provider.

The goal of the maintenance phase is to sustain the treatment’s effectiveness and manage the disease.

3 evaluation of treatment response

Throughout the trial, the response to treatment is evaluated using criteria known as Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

This evaluation helps in assessing the progression-free survival (PFS) and overall survival (OS) of participants.

4 monitoring and follow-up

Participants are monitored for any adverse events or side effects that may occur during the trial.

Regular follow-up appointments are scheduled to ensure the safety and well-being of participants and to adjust treatment as necessary.

Who Can Join the Study?

The patient must have a confirmed diagnosis of a type of lung cancer called nonsquamous NSCLC (Non-Small Cell Lung Cancer).
The patient must have stage IV nonsquamous NSCLC, which means the cancer has spread to other parts of the body.
The patient must not need specific treatments aimed at certain genetic changes in the cancer, like EGFR, ALK, or ROS1.
The patient must have cancer that can be measured using specific criteria called RECIST 1.1.
The patient must provide a sample of their tumor tissue, either from a previous sample or a new biopsy, to be checked by a central lab.
The patient must have a life expectancy of at least 3 months.
The patient must have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The patient must not have received previous treatments that affect the whole body for their advanced or metastatic NSCLC.
The patient must have organs that are working well enough to handle the treatment.
Male and female patients who can have children must use birth control during the treatment and for 180 days after.
Male patients must not donate sperm, and female patients must not donate eggs or store them for future use during the treatment and for 180 days after.

Who Cannot Join the Study?

Patients who do not have Stage IV lung cancer cannot participate. Stage IV means the cancer has spread to other parts of the body.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are part of a vulnerable population are not excluded, meaning they can participate if they meet other criteria.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Centre Jean Perrin	Clermont Ferrand	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
HELIOS Klinikum Erfurt GmbH	Erfurt	Germany
Hospital Del Mar	Barcelona	Spain
Klinikum Wels-Grieskirchen GmbH	Wels	Austria
Institut Fuer Versorgungsforschung In Der Onkologie GbR	Koblenz	Germany
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Ovidius Clinical Hospital S.R.L.	Ovidiu	Romania
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Med Polonia Sp. z o.o.	Poznan	Poland
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hospital Universitario Virgen De Valme	Sevilla	Spain
Oncomed S.R.L.	Timisoara	Romania
Hopitaux Prives De Metz	Vantoux	France
Muenchen Klinik gGmbH	Munich	Germany
Unite De Recherche Clinique HIA Begin	Saint-Mande	France
Cardiomed S.R.L.	Cluj Napoca	Romania
Klinikum Wuerzburg Mitte gGmbH	Wuerzburg	Germany
Spitalul De Oncologie Monza S.R.L.	Bucharest	Romania
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Centre Hospitalier De Pau	Pau	France
Cfouyz Hxtkwnexixa Di Cboeey	Chauny	France
Pfytzjfaxdw Lnsxgasp &njfiopdvbhtizuejxap Riydo Kwhnglvjakm	Konin	Poland
Nbeqwjfv Ijfktnov Ohjapkaqf Iit Mudnw Slvfpqpurxsdcnbvxqgkidkjlkfu Iklolivo Bsaqskgd	Cracow	Poland
Chugpb Hvuoestlkty Rgxtkqvn Dmdrthysruiucp	Angers	France
Krzocjrw Epeasbntqbzkyetvlpwnqfgb Htynqvdshndnyshlv	Essen	Germany
Kjjisfcyk Scfwkxa Svtfffdbgrzpkbb iq Jxml Pvjqa Ir	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	25.06.2019
France	Not recruiting	25.06.2019
Germany	Not recruiting	25.06.2019
Poland	Not recruiting	25.06.2019
Romania	Not recruiting	25.06.2019
Spain	Not recruiting	25.06.2019

Trial locations

Investigated drugs:

Pembrolizumab is a medication used in cancer treatment. It works by helping the immune system recognize and attack cancer cells. In this trial, it is used in combination with other medications to treat metastatic non-squamous non-small-cell lung cancer.

Pemetrexed is a chemotherapy drug that interferes with the growth of cancer cells. It is used in this trial as part of the initial treatment and as a maintenance therapy to help prevent the cancer from returning.

Platinum (Carboplatin or Cisplatin) refers to a group of chemotherapy drugs that contain platinum. These drugs work by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this trial, either carboplatin or cisplatin is used in combination with other medications to treat lung cancer.

Olaparib is a medication that targets cancer cells with specific genetic mutations. It works by blocking an enzyme that cancer cells need to repair their DNA, leading to cell death. In this trial, olaparib is used as a maintenance therapy to help keep the cancer from coming back after initial treatment.

Stage IV Lung Cancer – This is an advanced form of lung cancer where the disease has spread beyond the lungs to other parts of the body. It typically involves metastasis to areas such as the brain, bones, liver, or adrenal glands. Symptoms may include persistent cough, chest pain, shortness of breath, and weight loss. As the disease progresses, it can lead to more severe respiratory issues and systemic symptoms. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower course. The focus in managing this stage often involves controlling symptoms and maintaining quality of life.

Trial ID:

2023-509774-40-00

Protocol code:

MK-7339-006

NCT ID:

NCT03976323

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Pembrolizumab, Olaparib, and Pemetrexed for Patients with Stage IV Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?