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New combo attack on lung cancer: adding radiation to immunotherapy and chemo

NCT ID NCT03774732

Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether adding radiation to the standard combination of pembrolizumab (an immunotherapy) and chemotherapy can improve survival in people with advanced non-small cell lung cancer. About 327 participants with stage IIIB/IV disease will receive either the triple therapy or standard care. The goal is to see if radiation boosts the immune response against tumors outside the radiation field.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pembrolizumab (a drug that helps the immune system fight cancer) combined with chemotherapy (carboplatin, paclitaxel, nab-paclitaxel, cisplatin, or pemetrexed) and radiation therapy
What this could lead to
If successful, this combination could extend survival for people with advanced lung cancer beyond current standard treatments.
What could go wrong
This is a Phase 3 trial, but the added radiation may increase side effects without improving outcomes. Results may not apply to all lung cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 327 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA: 1. Patient must have signed a written informed consent form prior to any study specific procedures 2. Histologically or cytologically confirmed advanced (stage IIIB/IIIC/IV), squamous or non-squamous NSCLC 3. NSCLC patients eligible for treatment with pembrolizumab and chemotherapy according to the European Marketing Authorization: 1. squamous: in combination with carboplatin and either paclitaxel or nab-paclitaxel 2. non squamous with no EGFR or ALK positive mutations: in combination with pemetrexed and a platinum based chemotherapy 4. Patient ≥18 of age 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 6. Life expectancy \>3 months 7. Measurable lesion as assessed by RECIST version 1.1 8. Metastases and/or primary tumour eligible for 3 dimensional conventional radiotherapy (3D-CRT) or stereotactic ablative radiotherapy (SABR) in terms of dose constraints at organ at risk (according to QUANTEC review) 9. Patients must have adequate organ function defined by the following laboratory results obtained within 14 days prior to the first study treatment: 1. absolute neutrophil count of ≥1 500 /mm³ 2. platelets ≥ 100 000/mm³ 3. haemoglobin \>9 g/dL (transfusions allowed) 4. creatinine clearance \>60 mL/min 5. bilirubin ≤1.5 X upper limit of normal (ULN) (unless Gilbert's syndrome where 3 X ULN is permitted) 6. serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 X ULN (unless documented liver metastasis where ≤5 X ULN is permitted) 7. Alkaline phosphatase (ALP) ≤2.5 X ULN (unless documented bone or liver metastasis where ≤5 X ULN is permitted) 8. International normalized ratio (INR), prothrombin (PT), and prothrombin time (PTT) ≤1.5 X ULN (unless the subject is receiving anticoagulant therapy) 10. Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of study participation and up to 6 months after completing treatment/therapy 11. Patients affiliated to the social security system (or equivalent) 12. 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 NON-INCLUSION CRITERIA: 1. Non-squamous NSCLC with targetable tumor mutations, activating EGFR mutations or ALK translocation Note: documentation of these mutation for non-squamous histology is mandatory as standard of care 2. Stage IIIB/IIIC NSCLC patient eligible to curative (thoracic radiotherapy or surgery) treatments in first line treatment 3. Prior therapy with T-cell costimulation or checkpoint-targeted agents Note: Stage I-III NSCLC who previously received single-agent anti-PD(L)1 immunotherapy and ultimately develop metastases remain eligible (minimal immunotherapy washout period of 3 months) 4. Clinical need of radiotherapy (e.g.: whole brain irradiation, painful metastasis, bleeding, compressive metastases) 5. Irradiation within 2 months before inclusion 6. Leptomeningeal carcinomatosis, or metastases with indistinct borders making targeting not feasible 7. Patient with evidence of active (presence of symptoms or requiring steroid treatment) central nervous system (CNS) metastases and/or carcinomatous meningitis. Patient with brain metastasis can be included if asymptomatic and not requiring steroids 8. Metastases located within 3 cm of the previously irradiated structures (EQD2doses): 1. Spinal cord previously irradiated to \>40 Gy; 2. Brachial plexus previously irradiated to \>50 Gy; 3. Small intestine, large intestine, or stomach previously irradiated to \>45 Gy; 4. Brainstem previously irradiated to \>50 Gy; 5. Lung previously irradiated with prior V20Gy \>30% 9. Active autoimmune disease except vitiligo, type-1 diabetes, hypothyroid stabilized with hormonal substitution, psoriasis 10. Symptomatic interstitial lung disease 11. Systemic immunosuppression or systemic immunosuppressive medicinal products within 2 weeks prior to study entry 12. Concomitant treatment with steroids \> 10 mg Note1: higher dose of steroids can be prescribed in case of occurrence of toxicities during radiotherapy; prophylactic dose of maximum 1 mg per kg during 2 weeks are authorized during the delivery of more than 6 Gy per fraction Note2: temporary use of steroid (less than 4 weeks) at a dose of 1 mg/kg is accepted 13. Prior invasive malignancy within the past 2 years (except non-melanomatous skin cancer non-invasive carcinoma in-situ of the breast, oral cavity, bladder or cervix) 14. Known Acquired Immune Deficiency Syndrome (AIDS) or severe uncontrolled co-morbidity 15. Known currently active infection including hepatitis B and hepatitis C 16. Patient who was administered a live, attenuated vaccine within 28 days prior to enrolment 17. Patient with any other disease or illness that requires hospitalisation or is incompatible with the study treatment are not eligible. Patient unable to comply with study obligations for geographic, social, or physical reasons, or who is unable to understand the purpose and procedures of the study 18. Patient who have taken any investigational medicinal product or have used an investigational device within 30 days of inclusion 19. Pregnant or breast feeding woman 20. Person deprived of their liberty or under protective custody or guardianship 21. If pemetrexed: patient is unable or unwilling to take folic acid or vitamin B12 supplementation 22. Pre-existing peripheral neuropathy of a severity of grade ≥ 2 by NCI CTCAE v5.0 23. Known hypersensitivity to one of the compounds or substances used in this protocol 24. Major surgery within the 28 days before initiating study treatment

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non small cell lung cancer metastatic Non-small cell carcinoma of lung, TNM stage 4 Non-small cell lung cancer

Contacts and locations

Locations

  • CHRU de Brest

    Brest, France

  • CHU St Etienne

    Saint-Etienne, France

  • CHU Sud de la Réunion

    La Réunion, France

  • CHU de Nîmes

    Nîmes, France

  • CHU de Toulouse Hôpital Larrey

    Toulouse, France

  • Centre André DUTREIX

    Dunkirk, France

  • Centre Antoine Lacassagne

    Nice, France

  • Centre Azuréen De Cancérologie

    Mougins, France

  • Centre Catalan d'Oncologie

    Perpignan, France

  • Centre François Baclesse

    Caen, France

  • Centre Frédéric JOLIOT

    Rouen, France

  • Centre Georges Francois Leclerc

    Dijon, France

  • Centre Henri Becquerel

    Rouen, France

  • Centre Hospitalier Dr Jean-Eric TECHER

    Calais, France

  • Centre Hospitalier Intercommunal De Creteil

    Créteil, France

  • Centre Hospitalier Princesse Grace

    Monaco, Monaco

  • Centre Hospitalier Universitaire De Caen - Hôpital Cote De Nacre

    Caen, France

  • Centre Hospitalier William Morey

    Chalon-sur-Saône, France

  • Centre Hospitalier de Dunkerque

    Dunkirk, France

  • Centre Hospitalier de Montelimar

    Montélimar, France

  • Centre Hospitalier des Pays de Morlaix

    Morlaix, France

  • Centre Jean Perrin

    Clermont-Ferrand, France

  • Centre Joliot Curie

    Saint-Martin-Boulogne, France

  • Centre Marie Curie

    Arras, France

  • Centre Marie Curie

    Valence, France

  • Centre Oscar Lambret

    Lille, France

  • Centre Paul Strauss

    Strasbourg, France

  • Centre Pierre Curie

    Beuvry, France

  • Centre de cancérologie du grand Montpellier-Clinique Clementville

    Montpellier, France

  • Centre de radiothérapie et de cancérologie de Blois

    La Chaussée-Saint-Victor, France

  • Centre hospitalier de Cannes Simone Veil

    Cannes, France

  • Clinique Ambroise Pare

    Beuvry, France

  • Clinique Chenieux

    Limoges, 87039, France

  • Clinique Saint-Hilaire

    Rouen, France

  • Fondation Hôpital Saint-Joseph

    Paris, France

  • Gustave Roussy

    Villejuif, France

  • Hopital Charles Nicolle

    Rouen, France

  • Hopital Pitie Salpetriere

    Paris, France

  • Hopital Tenon

    Paris, France

  • Hôpital Européen Marseille

    Marseille, France

  • Hôpital Privé Arnault Tzanck

    Mougins, France

  • Hôpital Privé Arras Les Bonnettes

    Arras, France

  • Hôpital Privé Clairval

    Marseille, France

  • Hôpital Privé Drôme Ardèche

    Valence, France

  • Hôpital Simone Veil Blois

    Blois, France

  • Hôpital de Bicêtre

    Le Kremlin-Bicêtre, France

  • Institut Bergonie

    Bordeaux, France

  • Institut Claudius Regaud

    Toulouse, France

  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud, France

  • Institut De Cancerologie De Lorraine

    Vandœuvre-lès-Nancy, France

  • Institut Jean Godinot

    Reims, France

  • Institut Sainte Catherine

    Avignon, France

  • Institut de Cancérologie de Bourgogne

    Chalon-sur-Saône, France

  • Institut de Cancérologie de Bourgogne

    Dijon, France

  • Institut de Cancérologie de l'Ouest - Site Paul Papin

    Angers, France

  • Polyclinique de l'Ormeau

    Tarbes, France

  • Polyclinique du Parc Drevon

    Dijon, France

  • Pôle départemental de Cancérologie Libérale 37

    Chambray-lès-Tours, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.