NCT04475939CompletedPhase 3
Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum -Based Chemotherapy With Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line (SoC 1L) platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 666 (actual)
- First submitted
- 14 Jul 2020
- Start date
- 26 Oct 2020
- Primary completion date
- 26 Feb 2025
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Lung cancer
- NCT number
- NCT04475939
- EU CT number
- 2023-508443-40-00
- EudraCT number
- 2020-002202-20
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 666
- From 26 Oct 2020 to the primary completion date, 26 Feb 2025
- 164 sites in 27 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received prior Poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor(s) in prior lines of treatment.
- Has received colony-stimulating factors (granulocyte macrophage colony-stimulating factor or recombinant erythropoietin) within 4 weeks prior to the first dose of study treatment.
- Has an active or previously documented autoimmune or inflammatory disorder.
- Is receiving chronic systemic steroids (prednisone \>20 mg per day) other than intermittent use of bronchodilators, inhaled steroids, or local steroid.
- Has other active concomitant malignancy that warrants systemic, biologic, or hormonal therapy.
- Is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and/or for up to 180 days after the last dose of study treatment.
Other illness
- Has mixed small cell lung cancer or sarcomatoid variant NSCLC.
- Has any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
- Has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiographic signs of CNS hemorrhage.
- Has a known history of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).
- Has a known history of active tuberculosis.
- Has current active pneumonitis within 90 days of planned start of the study or a known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroid treatment.
Other
- Has systolic blood pressure (BP) \>140 millimeters of mercury (mmHg) or diastolic BP \>90 mmHg.
Who the study is looking for
- Participant must be \>=18 years of age.
- Has a histologically or cytologically confirmed diagnosis of NSCLC without known targetable driver alteration (either non-squamous or squamous histology; mixed histology is allowed for which an approved targeted therapy is available in the 1L induction/maintenance therapy setting).
- Has advanced (Stage IIIB or Stage IIIC, not amenable to definitive chemoradiotherapy) or metastatic (Stage IV) or metastatic (Stage IV) NSCLC.
- Has completed at least 4 but no more than 6 cycles of SoC 1L platinum-based induction chemotherapy with pembrolizumab.
- Has SD, PR, or CR of the NSCLC per Investigator's assessment after completion of 4 to 6 cycles of SoC 1L platinum-based induction chemotherapy with pembrolizumab.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a life expectancy of at least 12 weeks.
- Has adequate organ and bone marrow function.
- Must submit tumor specimens.
- Must be able to swallow and retain orally administered study treatment.
- A female is eligible to participate if she is not pregnant or breastfeeding and must follow contraceptive guidance during the treatment period and 180 days afterwards.
- A male is eligible to participate if he agrees to contraceptive guidance and refrains from sperm donation during the intervention period and for at least 90 days after the last dose of study treatment.
- Is able to understand the study procedures and agrees to participate in the study by providing written informed consent. Participants must be informed that their participation is voluntary. Participants will be required to sign a statement of informed consent to participate in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (164)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GSK Investigational Site Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Cipoletti Rio Negro | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aire | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Florida | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | La Plata | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ballarat | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Blacktown | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Hobart | Australia | Unknown status |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Multiprofessional Hospital For Active Treatment Park Hospital Ltd. Coordinator of this site? Confirm its status | Branipole | Bulgaria | Completed |
| Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Coordinator of this site? Confirm its status | Panagyurishte | Bulgaria | Completed |
| University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Completed |
| Complex Oncology Center Ruse EOOD Coordinator of this site? Confirm its status | Ruse | Bulgaria | Completed |
| MBAL Serdika Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Cachoeiro de Itapemirim | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Uberlândia | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Montería | Colombia | Unknown status |
| Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Asklepios Fachkliniken Muenchen-Gauting Coordinator of this site? Confirm its status | Gauting | Germany | Completed |
| LungenClinic Grosshansdorf GmbH Coordinator of this site? Confirm its status | Grosshansdorf | Germany | Completed |
| Martha-Maria Krankenhaus Halle-Doelau gGmbH Coordinator of this site? Confirm its status | Halle (saale) | Germany | Completed |
| Hamato-Onkologie Hamburg Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Klinikum Region Hannover GmbH Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Thoraxklinik Heidelberg gGmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH Coordinator of this site? Confirm its status | Hemer | Germany | Completed |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Completed |
| Muenchen Klinik gGmbH Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Robert Bosch Gesellschaft fuer medizinische Forschung mbH Coordinator of this site? Confirm its status | Stuttgart | Germany | Completed |
| MVZ-Onkologie Velbert GbR Coordinator of this site? Confirm its status | Velbert | Germany | Completed |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Institut Català d'Oncologia Coordinator of this site? Confirm its status | Girona | Spain | Completed |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Completed |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Completed |
| Centre Hospitalier Intercommunal Creteil Coordinator of this site? Confirm its status | Creteil Cedex | France | Completed |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Completed |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Completed |
| Institut de Cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Completed |
| Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Coordinator of this site? Confirm its status | Toulon Cedex | France | Completed |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Dundee | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Middlesex | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Wrexham | United Kingdom | Unknown status |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Henry Dunant Hospital Center Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. Coordinator of this site? Confirm its status | Cholargos | Greece | Completed |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Completed |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Completed |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Maroussi | Greece | Completed |
| Olympion Therapeftirio General Clinic Of Patras S.A. Coordinator of this site? Confirm its status | Patra | Greece | Completed |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Completed |
| Metropolitan Hospital Coordinator of this site? Confirm its status | Pireas | Greece | Completed |
| Metaxa Cancer Center Hospital Of Piraeus Coordinator of this site? Confirm its status | Pireas | Greece | Completed |
| Theageneio Cancer Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Bioclinic S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Euromedica General Clinic of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Orszagos Onkologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Completed |
| Matrai Gyogyintezet Coordinator of this site? Confirm its status | Gyöngyös | Hungary | Completed |
| Komarom-Esztergom Varmegyei Szent Borbala Korhaz Coordinator of this site? Confirm its status | Tatabánya | Hungary | Completed |
| Toeroekbalinti Tuedogyogyintezet Coordinator of this site? Confirm its status | Torokbalint | Hungary | Completed |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Completed |
| AORN San Giuseppe Moscati Avellino Coordinator of this site? Confirm its status | Avellino | Italy | Completed |
| Centro di Riferimento Oncologico di Aviano Coordinator of this site? Confirm its status | Aviano | Italy | Completed |
| Istituto Tumori Bari Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Completed |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Completed |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| Azienda Ulss 9 Scaligera Coordinator of this site? Confirm its status | Legnago | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Completed |
| Azienda Ospedaliera dei Colli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Completed |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Seongnam-si Gyeonggi-do | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Suwon Kyunggi-do | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Puebla Puebla | Mexico | Unknown status |
| Meander Medisch Centrum Coordinator of this site? Confirm its status | Amersfoort | Netherlands | Completed |
| Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Completed |
| University Hospital Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Completed |
| Jeroen Bosch Ziekenhuis Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Completed |
| St Antonius Ziekenhuis Coordinator of this site? Confirm its status | Utrecht | Netherlands | Completed |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Completed |
| Vestre Viken HF Coordinator of this site? Confirm its status | Drammen | Norway | Completed |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Completed |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Completed |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Completed |
| Oncomed S.R.L. Coordinator of this site? Confirm its status | Timisoara | Romania | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Omsk | Russia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Region Gaevleborg Coordinator of this site? Confirm its status | Gavle | Sweden | Completed |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Completed |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Lone Tree | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Newnan | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Niles | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Norwich | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Tallahassee | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Waco | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
Related publications
- Phase III Study of Niraparib Plus Pembrolizumab as Maintenance Therapy for Advanced or Metastatic NSCLC (ZEAL-1L).J Thorac Oncol · 2026 · PMID 42431263
This page is information, not medical advice. Discuss any trial with your doctor.