Study of Pembrolizumab and Olaparib with Chemoradiation for Patients with Stage III Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying treatments for Stage III Non-Small Cell Lung Cancer (NSCLC), a type of lung cancer that is locally advanced and cannot be removed by surgery. The study involves several medications, including Pembrolizumab (also known by its code name MK-3475), Olaparib, Durvalumab, Paclitaxel, Carboplatin, Etoposide, Pemetrexed, and Cisplatin. Some participants will receive a combination of these drugs along with a placebo, which is a substance with no active medication.

The purpose of the study is to compare the effectiveness of different treatment combinations in managing NSCLC. Participants will receive treatments through intravenous infusions or oral tablets, depending on the medication. The study will follow a specific course where participants will first receive a combination of Pembrolizumab with concurrent chemoradiation therapy, followed by either continued Pembrolizumab with or without Olaparib, or a switch to Durvalumab. The study aims to observe how these treatments affect the progression of the disease and overall survival of the participants.

Throughout the study, participants will be monitored for any side effects and changes in their health status. The trial will also assess the impact of the treatments on the quality of life, including symptoms like cough, chest pain, and breathing difficulties. The study is expected to continue until 2026, providing valuable insights into the management of Stage III NSCLC.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose and procedures. Written consent is required to confirm understanding and agreement to participate.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes reviewing medical history, performing pulmonary function tests, and ensuring adequate organ function.

3 treatment phase 1: concurrent chemoradiation therapy

Participants will receive pembrolizumab through intravenous infusion. This is combined with chemoradiation therapy, which involves the use of chemotherapy and radiation to treat cancer.

4 treatment phase 2: pembrolizumab with or without olaparib

Following the initial treatment, participants will continue with pembrolizumab infusions. Some participants may also receive olaparib, which is taken orally. The decision to include olaparib is based on specific study criteria.

5 alternative treatment phase: durvalumab

As an alternative to the pembrolizumab and olaparib combination, some participants will receive durvalumab through intravenous infusion after the initial chemoradiation therapy.

6 monitoring and follow-up

Throughout the study, participants will undergo regular monitoring to assess the treatment’s effectiveness and any side effects. This includes imaging tests and health assessments.

7 completion of the study

Upon completion of the treatment phases, participants will have a final assessment to evaluate overall health and treatment outcomes. Long-term follow-up may be required to monitor health status.

Who Can Join the Study?

The patient must have a confirmed diagnosis of non-small cell lung cancer (NSCLC). This means the type of lung cancer has been identified through specific tests.
Male patients must agree to use birth control and not donate sperm during the study and for a certain time after the last treatment dose, unless they are unable to produce sperm due to medical reasons.
Female patients must not be pregnant or breastfeeding. They must agree to use birth control, not donate eggs, and not breastfeed during the study and for a certain time after the last treatment dose.
Female patients must have a negative pregnancy test before starting the study treatment.
The patient’s medical and menstrual history, as well as recent sexual activity, will be reviewed to ensure there is no early undetected pregnancy.
The patient must have adequate lung function, meaning their lungs are working well enough to participate in the study.
The patient must have adequate organ function, meaning their organs are healthy enough to participate in the study.
The patient must provide written consent, agreeing to participate in the study.
The patient must have Stage IIIA, IIIB, or IIIC NSCLC, which refers to specific stages of lung cancer.
The patient must be unable to have surgery to completely remove the cancer for Stage III NSCLC.
The patient must not have evidence of cancer spreading to other parts of the body, which would indicate Stage IV NSCLC.
The patient must have measurable disease, meaning the cancer can be measured using specific criteria.
The patient must not have received previous treatment for Stage III NSCLC, such as chemotherapy or radiotherapy. Patients who had treatment for early-stage disease are not eligible.
The patient must provide a sample of their tumor tissue for analysis.
The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which indicates they are fully active or have some symptoms but can carry out light work.
The patient must have a life expectancy of at least 6 months.

Who Cannot Join the Study?

Patients who have a different type of cancer other than non-small cell lung cancer cannot participate. This type of cancer affects the lungs.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or take the required medications cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate, as the study may affect the baby.
Patients who have participated in another clinical trial recently may not be eligible to participate.
Patients who have allergies or reactions to the study medications cannot participate.
Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Oslo Universitetssykehus HF	Oslo	Norway
IRCCS Humanitas Research Hospital	Rozzano	Italy
Koranyi National Institute For Pulmonology	Budapest	Hungary
Universitaetsmedizin Goettingen	Goettingen	Germany
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Pauls Stradins Clinical University Hospital	Riga	Latvia
Ospedale Vito Fazzi Lecce	Lecce	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universita Cattolica Del Sacro Cuore	Rome	Italy
Zentralklinik Bad Berka GmbH	Bad Berka	Germany
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Helse Stavanger HF	Stavanger	Norway
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Johannes Wesling Klinikum Minden	Minden	Germany
Fakultni Nemocnice Bulovka	Prague	Czechia
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
LungenClinic Grosshansdorf GmbH	Grosshansdorf	Germany
Clinique de l’Europe	Amiens	France
Katholisches Marienkrankenhaus gGmbH	Hamburg	Germany
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
HIA Sainte Anne	Toulon	France
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Tartu University Hospital	Tartu	Estonia
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Spitalul Universitar De Urgenta Bucuresti	Bucharest	Romania
Oncomed S.R.L.	Timisoara	Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Hopital Prive Clairval	Marseille	France
Spitalul De Oncologie Monza S.R.L.	Bucharest	Romania
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
North Estonia Medical Centre Foundation	Tallin	Estonia
University Hospital Ostrava	Ostrava	Czechia
Krajska nemocnice Liberec a.s.	Liberec	Czechia
Scuqugmr Plubajxcb Shl z otkp	Gdynia	Poland
Csrvlipd Tojktrhq	Valenciennes	France
Jjbixmmsrbhnypukeluylrhtsks gozav	Neuss	Germany
Cig dxhpnwmfoywbqb	Epagny Metz Tessy	France
Bghusizdrir Veqyyzxzu Ojejrdgvddrb	Kecskemet	Hungary
Fhknbvek ntfvhkjne Mevxi a Hxjrtnf	Prague	Czechia
Abbiatmu Uomfveplqx Hmqfgvqr	Lorenskog	Norway
Rwqkn Ahqslsed kmcpausy uikceytnowtzg sgyjvvif Scu	Riga	Latvia
Grfpwylqcnuveeucy Vjfmxrlkn Phgo Atbamk Egugzrom Ogdgro Kondjf	Gyor	Hungary
Nemdkotu Igtlvxsi Obgcwopik Ikc Mmuuf Sswwadqfhkvrpqakaienzbopfntr Ikddmeto Bgdemxwm	Cracow	Poland
Hznkevlf Vqpm dgannzci	Barcelona	Spain
Vzcqcyhvf irhjovfr Vwladwxx uohbyboqxvro ljtovfmbo Sglqnuvr kdeqinu flzztwhu Nrdlthlzjfxt vrcdy cbxerfk	Vilnius	Lithuania

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	07.05.2020
Estonia	Not recruiting	07.05.2020
France	Not recruiting	07.05.2020
Germany	Not recruiting	07.05.2020
Hungary	Not recruiting	07.05.2020
Italy	Not recruiting	07.05.2020
Latvia	Not recruiting	07.05.2020
Lithuania	Not recruiting	07.05.2020
Norway	Not recruiting	07.05.2020
Poland	Not recruiting	07.05.2020
Romania	Not recruiting	07.05.2020
Spain	Not recruiting	07.05.2020

Trial locations

Investigated drugs:

Pembrolizumab is a medication used in this study to help the immune system fight cancer. It is given to participants in combination with other treatments to see if it can improve outcomes for those with a specific type of lung cancer that cannot be removed by surgery.

Olaparib is a medication that may help stop cancer cells from repairing themselves, which could make them more vulnerable to treatment. In this study, it is used alongside pembrolizumab to see if the combination is more effective than other treatments.

Durvalumab is another medication that helps the immune system attack cancer cells. It is used in this study as a comparison to see if it is more or less effective than the combination of pembrolizumab and olaparib in treating lung cancer.

Concurrent Chemoradiation Therapy is a standard treatment for certain types of cancer, including lung cancer. It involves giving chemotherapy and radiation therapy at the same time to try to shrink the tumor and stop the cancer from spreading. This therapy is used in combination with the medications being tested in the study.

Investigated diseases:

Non-small cell lung cancer

Non-small cell lung cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. It often grows and spreads more slowly than small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms.

Trial ID:

2023-503591-25-00

Protocol code:

MK-7339-012

NCT ID:

NCT04380636

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Pembrolizumab and Olaparib with Chemoradiation for Patients with Stage III Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?