Radiotherapy: Irradiation technique (3D-CRT or SABR) will be at physician discretion.
Pembrolizumab: pembrolizumab will be administered as per standard of care every 3 weeks until progression or toxicity
Chemotherapy: for squamous NSCLC carboplatin AUC6, paclitaxel 200 mg/m² every 3 weeks for 4 cycles; for non-squamous NSCLC carboplatin AUC5 or cisplatin 75 mg/m² every 3 weeks for 4 cycles, and pemetrexed 500 mg/m² every 3 weeks until progression or toxicity
Study summary
Overall survival (OS) of patients with advanced (stage IIIB/IV) non-small-cell lung cancer (NSCLC) remains short after the first line of treatment with a median OS of 12.2 months in non squamous NSCLC and 9.2 months in squamous NSCLC . In this setting the programmed death 1/ligand 1 (PD-1/-L1) were targeted with nivolumab (IgG4) in advanced squamous and nonsquamous NSCLC leading to an increase of the 1-year OS rate of approximately 10-15% in both histologies. Nivolumab, pembrolizumab and atezolizumab are now considered a standard of care in 2nd line advanced NSCLC and in 1st line for pembrolizumab but but prognosis still remains poor in advanced NSCLC. Overall survival (OS) of patients with advanced (stage III/IV) NSCLC remains limited with a median OS of 12.2 months in non-squamous NSCLC and 9.2 months in squamous NSCLC if anti-PD1 alone. It is of around 16 months if pembrolizumab is combined with chemotherapy.
Preclinical data indicates that anti-tumor efficacy is increased when anti-PD-1/-L1 are combined with irradiation (IR). Radiotherapy alone can elicit tumor cell death which can increase tumor antigen in the blood stream, favoring recognition by the immune system and its activation against tumor cells outside of the radiation field (="abscopal effect").
IR may also reverse acquired resistance to PD-1 blockade immunotherapy by limiting T-cell exhaustion.
Because of these preclinical and clinical data several studies analysing the combination of IR and anti-PD1 in NSCLC are ongoing. Among them, two studies are testing the administration of IR and nivolumab in stage III NSCLC: the NCT02768558 phase III trial (RTOG), and the NCT02434081 phase II trial (ETOP). Antonia et al \[2017\] tested the use of anti-PD-L1 after chemoradiotherapy in unresectable stage III NSCLC. Median time to distant metastasis was increased (23.2 months vs. 14.6 months, p\<0.001). An increase of OS is consequently expected.
However, no study involving concurrent RT and pembrolizumab combined with chemotherapy in advanced NSCLC is ongoing, which is the purpose of the present study, NIRVANA-Lung.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
1-year Overall Survival — 1 year The primary endpoint of this trial is overall survival (OS) defined as the time from randomization to the date of documented death from any cause or last follow-up.
Trial sites (58)
Facility
City
Region
Status
Institut de Cancérologie de l'Ouest - Site Paul Papin
Angers
France
Centre Marie Curie
Arras
France
Hôpital Privé Arras Les Bonnettes
Arras
France
Institut Sainte Catherine
Avignon
France
Centre Pierre Curie
Beuvry
France
Clinique Ambroise Pare
Beuvry
France
Hôpital Simone Veil Blois
Blois
France
Institut Bergonie
Bordeaux
France
CHRU de Brest
Brest
France
Centre François Baclesse
Caen
France
Centre Hospitalier Universitaire De Caen - Hôpital Cote De Nacre
Caen
France
Centre Hospitalier Dr Jean-Eric TECHER
Calais
France
Centre hospitalier de Cannes Simone Veil
Cannes
France
Centre Hospitalier William Morey
Chalon-sur-Saône
France
Institut de Cancérologie de Bourgogne
Chalon-sur-Saône
France
Pôle départemental de Cancérologie Libérale 37
Chambray-lès-Tours
France
Centre Jean Perrin
Clermont-Ferrand
France
Centre Hospitalier Intercommunal De Creteil
Créteil
France
Centre Georges Francois Leclerc
Dijon
France
Institut de Cancérologie de Bourgogne
Dijon
France
Polyclinique du Parc Drevon
Dijon
France
Centre André DUTREIX
Dunkirk
France
Centre Hospitalier de Dunkerque
Dunkirk
France
Centre de radiothérapie et de cancérologie de Blois
La Chaussée-Saint-Victor
France
CHU Sud de la Réunion
La Réunion
France
Hôpital de Bicêtre
Le Kremlin-Bicêtre
France
Centre Oscar Lambret
Lille
France
Clinique Chenieux
Limoges
France
Hôpital Européen Marseille
Marseille
France
Hôpital Privé Clairval
Marseille
France
Centre Hospitalier de Montelimar
Montélimar
France
Centre de cancérologie du grand Montpellier-Clinique Clementville
Montpellier
France
Centre Hospitalier des Pays de Morlaix
Morlaix
France
Centre Azuréen De Cancérologie
Mougins
France
Hôpital Privé Arnault Tzanck
Mougins
France
Centre Antoine Lacassagne
Nice
France
CHU de Nîmes
Nîmes
France
Fondation Hôpital Saint-Joseph
Paris
France
Hopital Pitie Salpetriere
Paris
France
Hopital Tenon
Paris
France
+ 18 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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