Actively Recruiting
De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction
Led by Intergroupe Francophone de Cancerologie Thoracique · Updated on 2025-04-01
1360
Participants Needed
44
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Immunotherapeutic approaches recently have demonstrated clinical efficacy in several cancer types, including melanoma and NSCLC. As a matter of fact, first registration trials of immune-checkpoints inhibitors (ICI) in second-line settings (pembrolizumab as well as nivolumab or atezolizumab) had stated that ICI could be continued until disease progression or not tolerable toxicity, up to 5 years. This is only for the first-line registration studies that the arbitrary maximal duration of treatment of 2 years was set up by the Companies sponsoring such trials. The aim is to study a de-escalation scheme of treatment from 2 years of immunotherapy to 6 months (27-weeks), in patients with controlled disease.
CONDITIONS
Official Title
De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Diagnosed with metastatic NSCLC (stage IV) confirmed by histology or cytology
- Local assessment of PD-L1 tumor content
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Weight loss less than 10% in the past 3 months
- No prior systemic anticancer therapy for advanced disease
- Age 18 to less than 75 years
- Life expectancy greater than 3 months
- Measurable tumor by CT or MRI according to RECIST 1.1
- Adequate tumor tissue available for molecular analysis
- Adequate biological functions including creatinine clearance ≥ 45 mL/min, neutrophils ≥ 1500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL, liver enzymes and bilirubin within specified limits
- Women of childbearing potential must use effective contraception and have negative pregnancy test
- Sexually active men must use effective contraception during treatment and 6 months after
- National health insurance coverage
You will not qualify if you...
- Small cell lung cancer or mixed tumors including small cell component
- Known EGFR activating mutations or HER2 exon 20 insertion
- Known ALK, ROS1, Ret, NTRK, NRG1 gene rearrangements
- Previous or active cancer within 3 years except certain treated cancers
- Persistent superior vena cava syndrome despite stenting
- Radiotherapy needed at start of treatment except palliative bone radiotherapy
- Untreated symptomatic brain metastases or recent brain radiotherapy
- History of primary immunodeficiency or recent immunosuppressive treatment
- Systemic corticosteroids >10 mg prednisone daily within 14 days before immunotherapy
- Active autoimmune diseases except certain controlled or benign conditions
- Active uncontrolled infections including tuberculosis and active hepatitis B or C
- Known HIV infection
- Live attenuated vaccine within 30 days prior to study
- Previous treatment with immune checkpoint inhibitors or chemotherapy for lung cancer
- Serious uncontrolled cardiac conditions or recent stroke
- Moderate or severe lung interstitial disease
- Inability to comply with study or follow-up due to social or psychological reasons
- Pregnant or breastfeeding women
- Legal incapacity or inability to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 44 locations
1
Aix-en-Provence - CH
Aix-en-Provence, France
Not Yet Recruiting
2
Amiens - Clinique de l'Europe
Amiens, France
Not Yet Recruiting
3
Angers - CHU
Angers, France
Not Yet Recruiting
4
Avignon - CH
Avignon, France
Not Yet Recruiting
5
Besançon - CHU
Besançon, France
Not Yet Recruiting
6
Bordeaux - Polyclinique
Bordeaux, France
Not Yet Recruiting
7
CHU de Bordeaux
Bordeaux, France
Not Yet Recruiting
8
Caen - CHU Côte de Nacre
Caen, France, 14000
Actively Recruiting
9
Cannes - CH
Cannes, France
Not Yet Recruiting
10
Chauny - Centre Hospitalier
Chauny, France
Not Yet Recruiting
11
CH
Colmar, France
Not Yet Recruiting
12
Centre Georges François Leclerc
Dijon, France
Not Yet Recruiting
13
CHRU Grenoble
Grenoble, France
Active, Not Recruiting
14
La Roche Sur Yon - CH
La Roche-sur-Yon, France, 85925
Not Yet Recruiting
15
CH de Versailles
Le Chesnay, France
Not Yet Recruiting
16
Centre Hospitalier - Pneumologie
Le Mans, France, 72000
Not Yet Recruiting
17
CHRU de Lille
Lille, France
Not Yet Recruiting
18
CHU de Limoges
Limoges, France
Not Yet Recruiting
19
Lyon - Hôpital Jean Mermoz
Lyon, France
Not Yet Recruiting
20
Marseille - Hôpital Européen
Marseille, France
Not Yet Recruiting
21
Meaux - CH
Meaux, France
Not Yet Recruiting
22
Metz - Hôpital Robert Schuman
Metz, France
Active, Not Recruiting
23
Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Not Yet Recruiting
24
Centre Hospitalier
Mulhouse, France, 68070
Not Yet Recruiting
25
Nantes - CHU Hôpital Laënnec
Nantes, France
Not Yet Recruiting
26
Nice - CRLCC
Nice, France
Not Yet Recruiting
27
Orléans - CHR
Orléans, France
Not Yet Recruiting
28
Paris - APHP - Hopital Tenon
Paris, France, 75020
Active, Not Recruiting
29
Institut CURIE
Paris, France, 75248
Not Yet Recruiting
30
Hôpital Bichat - Claude - Bernard
Paris, France
Actively Recruiting
31
Reims - CHU
Reims, France
Not Yet Recruiting
32
Rouen - CHU
Rouen, France
Not Yet Recruiting
33
Centre René Huguenin
Saint-Cloud, France, 92210
Not Yet Recruiting
34
CHU Saint-Etienne Pneumologie
Saint-Etienne, France, 42000
Not Yet Recruiting
35
Hôpital privé de la Loire
Saint-Etienne, France
Not Yet Recruiting
36
Institut de Cancérologie de l'Ouest - René Gauducheau
Saint-Herblain, France, 44805
Not Yet Recruiting
37
Saint-Nazaire - Clinique Mutualiste de l'Estuaire
Saint-Nazaire, France
Not Yet Recruiting
38
CHU de La Réunion-Site Sud
Saint-Pierre, France, 97448
Not Yet Recruiting
39
Centre Hospitalier
Saint-Quentin, France, 02100
Not Yet Recruiting
40
Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Not Yet Recruiting
41
Centre Hospitalier Intercommunal
Toulon, France
Not Yet Recruiting
42
Hôpital Larrey (CHU)
Toulouse, France, 31059
Not Yet Recruiting
43
CHRU de Tours
Tours, France
Not Yet Recruiting
44
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France, 54511
Not Yet Recruiting
Research Team
C
Clinical Operations Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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