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PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC • ClinicalTrials.gov ID: NCT04790253

Registry updated: 2026-10-16

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Description

In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.

Interventions

Prophylactic cranial irradiation (Radiation)
Prophylactic cranial irradiation (PCI) is a technique used to combat the occurrence of metastasis to the brain in highly aggressive cancers that commonly metastasize to brain, most notably small-cell lung cancer.

Eligibility criteria

Inclusion Criteria: * Age ≥ 18 years * Histologically/cytologically proven diagnosis of SCLC * Limited and extensive stage * LS SCLC: Stage I-III (T any, N any, M0, according to UICC TNM staging v8.0) that can be safely treated with definitive radiation doses. Excludes T3-4 due to multiple lung nodules that are too extensive or have tumour/nodal volume that is too large to be encompassed in a tolerable radiation plan. * ES SCLC: Stage IV (T any, N any, M 1a/b), or T3-4 due to multiple lung nodules that are too extensive or have tumour/nodal volume that is too large to be encompassed in a tolerable radiation plan. * Completed standard therapy prior to randomization: * For patients with LS-SCLC, this includes a combination of 4-6 cycles of platinum-based doublet chemotherapy and either definitive thoracic radiotherapy (including SBRT for early-stage T1-2 N0 M0 disease who do not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the treating physician, but is not mandated. * For patients with ES-SCLC, this includes 4-6 cycles of platinum-based doublet chemotherapy either with or without thoracic radiotherapy o Immunotherapy concurrent with and/or adjuvant to standard therapy is allowed at the discretion of the treating physician. * Absence of progressive disease after completed standard therapy on systemic imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of Chest/Abdomen/Pelvis and brain MRI), 28 days before randomization. * Absence of brain metastases or leptomeningeal disease after completed standard therapy on systemic imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of Chest/Abdomen/Pelvis and brain MRI), within 28 days before randomization. * Interval from day 1 of last cycle of chemotherapy to randomization of ≤8 weeks * ECOG PS ≤ 2 * Estimated creatinine clearance ≥ 30 mL/min as calculated using the MDRD formula * Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to randomization. Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression or other reasons. * Patients Women of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the entire period of the radiotherapy treatment study participation and for at least 30 days after the last dose of radiotherapy. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include: * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) * Intrauterine device (IUD) * Intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomized partner * Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient) * Female subjects who are breast feeding should discontinue nursing prior to the first dose of radiotherapy and during the entire period of the radiotherapy treatmentuntil 30 days after the administration of the last dose of radiotherapy. * Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up * Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: * Prior radiotherapy to the brain or whole brain radiotherapy. Note: Patients who have undergone prior stereotactic radiosurgery for benign tumours or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis. Discussion with EORTC Headquarters is mandatory, before the randomization. * Known contraindication to imaging tracer or any product of contrast media, such as allergy or insufficient renal function. Known contraindication to MRI, such as implanted metal devices or foreign bodies. * Other active hematologic or solid tumour malignancy requiring current active treatment. * Any unresolved toxicities from prior therapy (e.g., chemotherapy, radiotherapy) greater than CTCAE grade 2 (according to CTCAE v5.0) at the time of randomization. * Patient with severe active comorbidities, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to randomization * Transmural myocardial infarction within 6 months prior to randomization * Acute infection requiring treatment at the time of randomization * Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of randomization * Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease * HIV positive with CD4 count \< 200 cells/microliter. Note: patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 16 weeks prior to randomization. * Any severe comorbidity that in the opinion of the Investigator might hamper the participation to the study and/or the treatment administration. * Severe neurological (including dementia and epilepsy) or psychiatric disorder requiring active treatment. * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial

Conditions

Limited Stage Small Cell Lung Cancer Extensive-stage Small-cell Lung Cancer

Locations

Medical University of Graz - Radio-oncology — Graz, Austria
Institut Jules Bordet — Anderlecht, Belgium
Universitair Ziekenhuis Antwerpen — Edegem, Belgium
AZ Groeninge Kortrijk - Campus Kennedylaan — Kortrijk, Belgium
C.H.U. Sart-Tilman — Liège, Belgium
Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus — Wilrijk, Belgium
Institut de Cancerologie de l Ouest (ICO) - Angers — Angers, France
Institut Sainte Catherine (UNICANCER) — Avignon, France
Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (UNICANCER) — Bayonne, France
Institut Bergonie (UNICANCER) — Bordeaux, France
Centre Francois Baclesse (CLCC) (UNICANCER) — Caen, France
Centre Hospitalier Metropole Savoie — Chambéry, France
Centre Hospitaliler Cholet — Cholet, France
Centre Hopitalier Intercommunal De Creteil — Créteil, France
CHU de Dijon - Centre Georges-Francois-Leclerc (UNICANCER) — Dijon, France
Centre Hospitalier Departemental Vendee (UNICANCER) — La Roche-sur-Yon, France
Centre Oscar Lambret — Lille, France
Centre Hospitalier Bretagne Sud - Site du Scorff — Lorient, France
Institut Paoli-Calmettes (UNICANCER) — Marseille, France
Institut du Cancer de Montpellier (UNICANCER) — Montpellier, France
Assistance Publique Hopitaux Paris- APHP - APHP Sorbonne Univ - Hopital la Pitie-Salpetriere — Paris, France
Institut Curie- Hopital de Paris — Paris, France
Centre Catalan d'Oncologie (UNICANCER) — Perpignan, France
Centre Catalan d'Oncologie — Perpignan, France
CHU de Lyon - Hopital Lyon Sud (UNICANCER) — Pierre-Bénite, France
Centre Henri Becquerel (UNICANCER) — Rouen, France
Hospi Grand Ouest - Clinique Mutualiste de l'Estuaire — Saint-Nazaire, France
CHU Saint-Etienne - Hopital Nord — Saint-Priest-en-Jarez, France
Institut de Cancerologie Strasbourg Europe (UNICANCER) — Strasbourg, France
Polyclinique de l'Ormeau — Tarbes, France
Institut de Cancerologie de Lorraine — Vandœuvre-lès-Nancy, France
Centre d'Oncologie Saint-Yves — Vannes, France
Gustave Roussy (UNICANCER) — Villejuif, France
IRCCS Azienda Ospedaliera Universitaria San Martino "IST" - IRCCS - AUO San Martino - IST — Genova, Italy
ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital — Legnago, Italy
Fondazione IRCCS - Policlinico San Matteo — Pavia, Italy
ASST-Bergamo Ospedale Treviglio-Caravaggio — Treviglio, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma — Verona, Italy
University Medical Center Groningen — Groningen, Netherlands
Medical University Of Gdansk — Gdansk, Poland
Regional Cancer Centre — Olsztyn, Poland
Hospital Universitario Badajoz — Badajoz, Spain
Hospital Insular De Gran Canaria — Las Palmas de Gran Canaria, Spain
Hospital Universitario Puerta De Hierro — Majadahonda, Spain
Inselspital — Bern, Switzerland
Reseau Hospitalier Neuchatelois - RHNe - La Chaux de Fonds — La Chaux-de-Fonds, Switzerland
Kantonsspital St Gallen — Sankt Gallen, Switzerland
UniversitaetsSpital Zurich — Zurich, Switzerland
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre — Bristol, United Kingdom
NHS Lothian - Western General Hospital — Edinburgh, United Kingdom
Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital — Maidstone, United Kingdom
The Christie NHS Foundation Trust — Manchester, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital — Nottingham, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital — Sheffield, United Kingdom
Royal Marsden Hospital - Sutton — Sutton, United Kingdom

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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