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

Other Sites

Site Name	City	Country
University Hospital Ostrava	Ostrava	Czechia
Spitalul Universitar De Urgenta Bucuresti	Bucharest	Romania
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Fakultni Nemocnice Bulovka	Prague	Czechia
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
LungenClinic Grosshansdorf GmbH	Grosshansdorf	Germany
Cfzfkx Hjmuhfymvso Dqzvfnstsjsvs Vpzkex	La Roche sur Yon	France
Hsiiecnu Vjts dmkuhuhb	Barcelona	Spain
Nqzik Efpgkky Mkrzsgp Clujvr Fiyjlqdslz	Tallin	Estonia
Fgpizxxs nlpejsyjs Mnqho a Hhyslti	Prague	Czechia
Afdnvomj Uivheaunxb Hqtapshe	Lorenskog	Norway
Hambigwu Ctzcpn Dw Bpxmlnwsb	Barcelona	Spain
Cnokebg Ujeixevkpdztayxvttyc Bkmqwm Kuu	Berlin	Germany
Fwntwtcr Njursbdwd Kpqnosegx Vyolmkvcp	Prague	Czechia
Akfxvtm Srhconyop Unelcrbqtiypn Fmbsxn Cwbhhokq	Udine	Italy
Hobhv Svnjdasug Hr	Stavanger	Norway
Jimyebwo Wwqtwpd Kxlsqwnn Mkljdd	Minden	Germany
Ssqzlldp Pcbxrbqwp Sqq z obqs	Gdynia	Poland
Seklvce Kbcisuojb Mygxzqlqprnl Sjvnz Wqiqvgvahjmu I Afvybrirrkgeo Z Waiukzftcsknxzetipk Cufknhj Oibzhujpj W Ocqockuwb	Olsztyn	Poland
Fhevzzqrcq Ibjdtrqsgw Idfitqtg Npryzydyfcy Bbxxf	Milan	Italy
Padue Syijavnj Clhmomcu Uuguelyibd Hpsqkzgn	Riga	Latvia
Oahzyumc Vhst Fwsxa Laxom	Lecce	Italy
Ctflplq Dh Ocruepgcx Se Ngthrtox Svqtre	Craiova	Romania
Hvi Sjqczo Alcu	Toulon	France
Bgjcrcwjmex Vqvfvqiwo Ohweqsucbzuy	Kecskemet	Hungary
Jccxelebvmnsyaanubobckvvnxr grzwl	Neuss	Germany
Cqxbbmnv Twjvylgn	Valenciennes	France
Crtkelgj dl lsqieupxcetepy	Amiens	France
Vpbmadlsv ihlmphve Vrmapuur uozeluuusree lplmxwpau Sqhqdgij kojzjob fwaqrxie Napniiolwswc vmqqm ciqrfpv	Vilnius	Lithuania
Crk dxjyyzslqmupfs	Epagny Metz Tessy	France
Kdexhnu nxhgailzg Ldqatfp aukb	Liberec	Czechia
Teotl Uzkgpbdecw Hqpsgvfu	Tartu	Estonia
Hmsyyckn Ukdstxfhpvxjh Qfdcweyhqow Mqptvi	Pozuelo De Alarcon	Spain
Ohpxyoe Sidykn	Timisoara	Romania
Gkgfrrbznshqdxkhl Vuqovzhln Pwkw Aijrfd Emnguzxb Ovvfum Kcohdb	Gyor	Hungary
Hzkpjnq Pwbzl Cbuqsmid	Marseille	France
Syyyrvrs Dz Owcxhepps Mzxbt Scrsxp	Bucharest	Romania
Uvylsvreii Calzhbeed Duy Svugl Cbphc	Rome	Italy
Zkbfhhzlvkivo Bjv Bxhzf Grsm	Bad Berka	Germany
Ksxtoijuwzme Mnyodnjgfycxjcytq gukca	Hamburg	Germany
Leiamcrn strotxueb mbwxrp ufbhjyaclqxt lysdffax Khwqh kcsxuslr	Kaunas	Lithuania
Rrhjcuswngxh Cynopt Csrt Siqlsa	Floresti	Romania
Repvo Ayxocyjv klahxehq uzcfbdjguhqjj skznommy Scr	Riga	Latvia
Nyaezwfk Itwggqkc Orfifqywr Iyf Mtaha Soyqyyjcdifggebvvcgtkyixdsfy Isigoxcs Bhdkzhmg	Cracow	Poland
Vhvwolrmw Fkdsqubh Ncqqigyvf V Pyvmk	Prague	Czechia

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?