Study of Niraparib and Pembrolizumab for Patients with Advanced Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC). The study is investigating the effectiveness of a combination of two treatments: Niraparib and Pembrolizumab. Niraparib is a medication that is taken orally in tablet form, while Pembrolizumab is given as an infusion, which means it is administered directly into the bloodstream through a vein. The trial will compare the effects of these medications against a placebo, which is a substance with no active drug, to see if the combination can help maintain the stability of the disease or improve the response after initial chemotherapy treatment.

The purpose of the study is to determine if the combination of Niraparib and Pembrolizumab can help patients live longer without the disease getting worse, and to see if it can improve overall survival compared to the placebo. Participants in the study will have already received a first-line treatment with platinum-based chemotherapy and Pembrolizumab, and their disease should have either remained stable or shown improvement. The study will involve regular monitoring and assessments to track the progress of the disease and the effects of the treatment.

Throughout the study, participants will receive either the combination of Niraparib and Pembrolizumab or a placebo with Pembrolizumab. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are unbiased. The study will continue for a set period, during which participants will be closely monitored for any changes in their condition and any side effects they may experience. The ultimate goal is to find a more effective maintenance therapy for patients with advanced or metastatic NSCLC.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and ability to take oral medication.

Participants must have completed a certain number of chemotherapy cycles and show stable or improved disease status.

2 treatment phase

Participants receive a combination of medications as maintenance therapy. This includes pembrolizumab, administered as an infusion, and either niraparib or a placebo, taken orally.

The dosage for pembrolizumab is 25 mg/mL, and it is given as a solution for infusion. The specific dosage and frequency for niraparib or placebo are determined by the study protocol.

3 monitoring and assessments

Regular assessments are conducted to monitor the progression of the disease and overall health. This includes imaging tests and evaluations based on specific criteria.

Participants are observed for any side effects or adverse reactions to the medications.

4 end of treatment

The treatment phase continues until the study’s end date or until specific criteria for discontinuation are met.

Participants may continue to be monitored for a period after the treatment phase to assess long-term effects and overall survival.

Who Can Join the Study?

  • Participants must be at least 18 years old. In Korea, participants must be at least 19 years old.
  • Participants who had side effects from their initial treatment must have recovered to a certain level of health, and there should be no severe ongoing side effects.
  • Participants must be able to swallow and keep the study medication in their system.
  • Female participants must not be pregnant or breastfeeding. They must either not be of childbearing potential or use a highly effective birth control method. They must also have a negative pregnancy test before starting the study.
  • Male participants must agree not to donate sperm and either abstain from sexual activity or use a condom during the study and for 90 days after the last dose.
  • Participants must understand the study procedures and agree to participate by signing a consent form.
  • Participants must have a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) without specific genetic changes that can be targeted by approved treatments.
  • Participants must have advanced or metastatic NSCLC, meaning the cancer has spread and cannot be treated with standard chemotherapy and radiation.
  • Participants must have completed 4 to 6 cycles of initial chemotherapy with pembrolizumab, a type of cancer treatment.
  • Participants must have stable disease, partial response, or complete response to their cancer treatment as assessed by their doctor.
  • Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can carry out light work.
  • Participants must have a life expectancy of at least 12 weeks.
  • Participants must have adequate organ and bone marrow function, which includes specific levels of blood cells and liver function.
  • Participants must provide a sample of their tumor tissue, preferably collected after being diagnosed with advanced or metastatic NSCLC and before starting initial treatment.

Who Cannot Join the Study?

  • Patients with other types of cancer besides Non-Small Cell Lung Cancer cannot participate. This means if you have a different kind of cancer, you are not eligible.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for people in certain age groups.
  • Patients who are part of a vulnerable population, which means people who might need special protection or care, are not eligible for this study.
  • Patients who do not meet the specific health requirements set by the study cannot participate. This means if your health condition does not match what the study needs, you cannot join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Metaxa Cancer Center Hospital Of Piraeus Piraeus Greece
Orszagos Onkologiai Intezet Budapest Hungary
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Netherlands Cancer Institute Amsterdam The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Asklepios Klinik Gauting GmbH Gauting Germany
Klinikum Region Hannover GmbH Hanover Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Euromedica General Clinic Of Thessaloniki Thessaloniki Greece
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
University General Hospital Of Heraklion Heraklion Greece
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Medisch Spectrum Twente Enschede The Netherlands
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
AORN San Giuseppe Moscati Avellino Avellino Italy
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte Bulgaria
Multiprofessional Hospital For Active Treatment Park Hospital Ltd. Branipole Bulgaria
MVZ-Onkologie Velbert GbR Velbert Germany
Henry Dunant Hospital Center Athens Greece
Complex Oncology Center Ruse EOOD Ruse Bulgaria
MBAL Serdika Ltd. Sofia Bulgaria
Bioclinic S.A. Thessaloniki Greece
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
General University Hospital Of Larissa Larissa Greece
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Matrai Gyogyintezet Gyongyos Hungary
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Vestre Viken HF Drammen Norway
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Karolinska University Hospital Solna Sweden
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Meander Medical Center Amersfoort The Netherlands
Universita’ Di Pisa Pisa Italy
Oncomed S.R.L. Timisoara Romania
General University Hospital Of Patras Patras Greece
Centre Hospitalier Universitaire De Nantes Nantes France
Muenchen Klinik gGmbH Munich Germany
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH Hemer Germany
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Centre Hospitalier Universitaire De Rennes Rennes France
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Hopital Beaujon Clichy France
Region Halland Varberg Sweden
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Olympion Therapeftirio General Clinic Of Patras S.A. Patras Greece
Metropolitan Hospital Athens Greece
Utkrwgjowczwfqgytoebn Etrlw Asb Essen Germany
Hdfiuusy Utxcwhwzcuwjp Maglzxu Dx Vtxiwbcyja Santander Spain
Awnrard Ufhp 9 Szrzmngsf Legnago Italy
Tzqspijqiz Ctynrp Hpkqcoga Thessaloniki Greece
Liyjy Gkxvnlp Hqykfcek Oc Arpexe Athens Greece
Alpsqcxp Ubkrdmcnuh Hgvyekrt Lorenskog Norway
Uzhdqej Uayqcfwfuj Hiyxymnx Uppsala Sweden
Aeargo Mydamhr Ctdvyi Scif Thessaloniki Greece
Ktnecfch diu Ujbvbpaykrcq Msbmazia Azs Munich Germany
Ucwzoggvce Or Adtnjhs Edegem Belgium
Iqtrfntu Cgqydh Dteuvcmypenvalkbr L'hospitalet De Llobregat Spain
Fcxfdzofo Pnmk Lm Iszjvsghaskkh Biulkwgse Dis Hzmobwei Urymshbuzfckw Lf Pay Madrid Spain
Hsleprrw Vasw doccejvv Barcelona Spain
Hpzfhxvg Uolbabchdfzck dk A Cyjiex A Coruna Galicia Spain
Uomivcjfwh Gbvnwqm Hysodnqg Awokoav Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
29.01.2021
Bulgaria Bulgaria
Not recruiting
29.01.2021
France France
Not recruiting
29.01.2021
Germany Germany
Not recruiting
29.01.2021
Greece Greece
Not recruiting
29.01.2021
Hungary Hungary
Not recruiting
29.01.2021
Ireland Ireland
Not recruiting
29.01.2021
Italy Italy
Not recruiting
29.01.2021
Norway Norway
Not recruiting
29.01.2021
Poland Poland
Not recruiting
29.01.2021
Romania Romania
Not recruiting
29.01.2021
Spain Spain
Not recruiting
29.01.2021
Sweden Sweden
Not recruiting
29.01.2021
The Netherlands The Netherlands
Not recruiting
29.01.2021

Trial locations

Niraparib is a medication used in this trial as part of a maintenance therapy. It is designed to help keep the cancer from growing or spreading after initial treatment. Niraparib works by interfering with the cancer cells’ ability to repair their DNA, which can lead to the death of these cells.

Pembrolizumab is an immunotherapy drug used in this trial. It helps the body’s immune system recognize and attack cancer cells. Pembrolizumab works by blocking a specific protein on the surface of immune cells, which can enhance the immune response against cancer cells.

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 cells lining the lungs and can spread to other parts of the body. As it progresses, it may cause symptoms like persistent cough, chest pain, and shortness of breath. The progression of the disease can vary, with some tumors growing slowly and others more rapidly. Early detection is crucial for managing the disease effectively.

Trial ID:
2023-508443-40-00
Protocol code:
213400
NCT ID:
NCT04475939
Trial Phase:
Therapeutic confirmatory (Phase III)

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