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Limited Stage Small Cell Lung CancerPRIMALungNCT04790253

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

A study testing Prophylactic cranial irradiation in people with Limited Stage Small Cell Lung Cancer and Extensive-stage Small-cell Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 55 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Prophylactic cranial irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
55 sitesin 9 countries
Study dates
27 Oct 2022to Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

55 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

EORTC Reception contact

+3227741611

eortc@eortc.org

55 sites in 9 countries

France27 sites, 27 recruiting

  • Institut de Cancerologie de l Ouest (ICO) - Angers

    Angers, FR 49055

    Recruiting

  • Institut Sainte Catherine (UNICANCER)

    Avignon, 84918

    Recruiting

  • Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (UNICANCER)

    Bayonne, 64100

    Recruiting

  • Institut Bergonie (UNICANCER)

    Bordeaux, 33067

    Recruiting

  • Centre Francois Baclesse (CLCC) (UNICANCER)

    Caen, 14076

    Recruiting

  • Centre Hospitalier Metropole Savoie

    Chambéry, FR 73000

    Recruiting

  • Centre Hospitaliler Cholet

    Cholet, FR 49325

    Recruiting

  • Centre Hopitalier Intercommunal De Creteil

    Créteil, FR 94010

    Recruiting

  • CHU de Dijon - Centre Georges-Francois-Leclerc (UNICANCER)

    Dijon, 21079

    Recruiting

  • Centre Hospitalier Departemental Vendee (UNICANCER)

    La Roche-sur-Yon, 85925

    Recruiting

  • Centre Oscar Lambret

    Lille, FR 59020

    Recruiting

  • Centre Hospitalier Bretagne Sud - Site du Scorff

    Lorient, FR 56322

    Recruiting

  • Institut Paoli-Calmettes (UNICANCER)

    Marseille, 13237

    Recruiting

  • Institut du Cancer de Montpellier (UNICANCER)

    Montpellier, 34298

    Recruiting

  • Assistance Publique Hopitaux Paris- APHP - APHP Sorbonne Univ - Hopital la Pitie-Salpetriere

    Paris, FR 75013

    Not yet recruiting

  • Institut Curie- Hopital de Paris

    Paris, FR 75248

    Not yet recruiting

  • Centre Catalan d'Oncologie (UNICANCER)

    Perpignan, 66000

    Recruiting

  • Centre Catalan d'Oncologie

    Perpignan, FR 66000

    Recruiting

  • CHU de Lyon - Hopital Lyon Sud (UNICANCER)

    Pierre-Bénite, 69495

    Recruiting

  • Centre Henri Becquerel (UNICANCER)

    Rouen, 76038

    Recruiting

  • Hospi Grand Ouest - Clinique Mutualiste de l'Estuaire

    Saint-Nazaire, FR 44600

    Not yet recruiting

  • CHU Saint-Etienne - Hopital Nord

    Saint-Priest-en-Jarez, FR 42270

    Not yet recruiting

  • Institut de Cancerologie Strasbourg Europe (UNICANCER)

    Strasbourg, 67200

    Recruiting

  • Polyclinique de l'Ormeau

    Tarbes, FR 65000

    Recruiting

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, FR 54519

    Recruiting

  • Centre d'Oncologie Saint-Yves

    Vannes, FR 56000

    Recruiting

  • Gustave Roussy (UNICANCER)

    Villejuif, 94805

    Recruiting

Other trials in France

United Kingdom7 sites, 7 recruiting

  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

    Bristol, BS2 8ED

    Recruiting

  • NHS Lothian - Western General Hospital

    Edinburgh, EH4 2XU

    Not yet recruiting

  • Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital

    Maidstone, ME16 9QQ

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Recruiting

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham, NG5 1PB

    Recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

    Sheffield, S10 2SJ

    Recruiting

  • Royal Marsden Hospital - Sutton

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

Belgium5 sites, 4 recruiting

  • Institut Jules Bordet

    Anderlecht, 1070

    Recruiting

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

    Recruiting

  • AZ Groeninge Kortrijk - Campus Kennedylaan

    Kortrijk, 8500

    Recruiting

  • C.H.U. Sart-Tilman

    Liège, 4000

    Terminated

  • Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus

    Wilrijk, 2610

    Recruiting

Other trials in Belgium

Italy5 sites, 5 recruiting

  • IRCCS Azienda Ospedaliera Universitaria San Martino "IST" - IRCCS - AUO San Martino - IST

    Genova, 16132

    Not yet recruiting

  • ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

    Legnago, 37045

    Not yet recruiting

  • Fondazione IRCCS - Policlinico San Matteo

    Pavia, 27100

    Not yet recruiting

  • ASST-Bergamo Ospedale Treviglio-Caravaggio

    Treviglio, 24047

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

    Verona, 37134

    Not yet recruiting

Other trials in Italy

Switzerland4 sites, 4 recruiting

  • Inselspital

    Bern, 3010

    Recruiting

  • Reseau Hospitalier Neuchatelois - RHNe - La Chaux de Fonds

    La Chaux-de-Fonds, 2303

    Recruiting

  • Kantonsspital St Gallen

    Sankt Gallen, 9007

    Recruiting

  • UniversitaetsSpital Zurich

    Zurich, 8091

    Recruiting

Other trials in Switzerland

Spain3 sites, 3 recruiting

  • Hospital Universitario Badajoz

    Badajoz, 06080

    Not yet recruiting

  • Hospital Insular De Gran Canaria

    Las Palmas de Gran Canaria, 35016

    Not yet recruiting

  • Hospital Universitario Puerta De Hierro

    Majadahonda, 28222

    Recruiting

Other trials in Spain

Poland2 sites, 2 recruiting

  • Medical University Of Gdansk

    Gdansk, 80 211

    Recruiting

  • Regional Cancer Centre

    Olsztyn, 10 228

    Recruiting

Other trials in Poland

Austria1 site, 1 recruiting

  • Medical University of Graz - Radio-oncology

    Graz, 8036

    Recruiting

Other trials in Austria

Netherlands1 site, 1 recruiting

  • University Medical Center Groningen

    Groningen, NL 9713 GZ

    Not yet recruiting

Other trials in Netherlands

About this study

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.

Read the detailed description

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 under the treatment policy strategy.

The secondary objectives are:

  • To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of cognitive failure free survival (CFFS) compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population.
  • To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of global health status/QoL and cognitive functioning according to EORTC QLQ-C30 questionnaire compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population.
  • To evaluate the frequency and severity of toxicities according to CTCAE v5.0 in the two arms in the treated population (i.e. patients who have started treatment).

The exploratory objectives are:

  • To compare OS and CFFS between the arms within the subgroups of patients with LS and ES disease.
  • To compare OS and CFFS between the arms within the subgroups: HA-PCI or not, first-line immunotherapy or not, memantine or not.
  • To compare cognitive failure free survival (CFFS) rate at 12 months after randomization between the arms.
  • To compare the cumulative incidence of cognitive failures with death as a competing risk between the arms.
  • To compare brain-metastasis-free survival (BMFS) between the arms.
  • To compare progression free survival (PFS) between the arms.
  • To compare time to brain-metastasis-attributed death (TBMAD) between the arms.
  • To compare other QoL scales according to EORTC QLQ-C30 and QLQ-BN20 questionnaires between arms.
  • To evaluate the cost-effectiveness of MRI surveillance alone versus MRI surveillance combined with PCI.
  • To collect blood for biobanking.
Being tested
Prophylactic cranial irradiation
Keywords
Prophylactic cerebral Irradiation, small cell lung cancer, PCI
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prophylactic cranial irradiationRadiation

    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.

Study groups in NCT04790253
Study groupRoleWhat they receive
PCI followed by brain MR surveillanceActive comparatorProphylactic cranial irradiation will be delivered at the dose of 25 Gy in 10 fractions to the whole brain. Patients must have a brain MRI performed within 28 days before randomisation and at 3, 6, 9, 12, 18 and 24 months. Extracranial imaging is recommended and will be performed per institutional standards at the discretion of the treating physician.
Receives: Radiation: Prophylactic cranial irradiation
MRI Active SurveillanceNo interventionPatients must have a brain MRI performed within 28 days before randomisation and at 3, 6, 9, 12, 18 and 24 month. Clinical evaluation will be performed every 3 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    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

    Measured: 12 Months

Secondary outcomes (3)

  1. cognitive failure free survival

    To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of cognitive failure free survival (CFFS) compared to prophylactic cranial irradiation (PCI)

    Measured: 12 Months

  2. Quality of Life

    To show that brain MRI surveillance is superior in terms of global health status/QoL and cognitive functioning according to EORTC QLQ-C30 questionnaire compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance

    Measured: 12 Months

  3. Safety profiling

    To evaluate the frequency and severity of toxicities according to CTCAE v5.0 in the two arms in the treated population (i.e. patients who have started treatment).

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2021
  2. Study start27 Oct 2022
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
After eligibility checks, patients will be randomized between the 2 arms, and stratified by stage of disease (limited versus extensive), immunotherapy as part of the first-line treatment (yes/no), and ECOG Performance Status (0 or 1 versus 2).
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04790253
Sponsor's protocol ID
EORTC-1901-LCG
Acronym
PRIMALung
Status last verified
Oct 2026
First submitted
5 Mar 2021
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Prophylactic cranial irradiation in people with Limited Stage Small Cell Lung Cancer and Extensive-stage Small-cell Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 55 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in France, United Kingdom, Belgium, Italy, Switzerland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact EORTC Reception (+3227741611, eortc@eortc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04790253.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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