Actively Recruiting
A Phase II-III Trial Comparing Pembrolizumab Maintenance Until Progression Versus Observation After 6 Months of Platinum-based Chemotherapy Plus Pembrolizumab in Stage IV NSCLC
Led by Intergroupe Francophone de Cancerologie Thoracique · Updated on 2025-04-01
1360
Participants Needed
44
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ways to reduce the duration of immunotherapy treatment in patients with advanced non-small cell lung cancer (NSCLC) who have their disease controlled after initial treatment. The study focuses on comparing a shorter immunotherapy maintenance period of 6 months to the usual 2 years to see if less treatment can still be effective. This phase II-III randomized study enrolls patients with stage IV NSCLC who have not received prior treatment for advanced disease. Participants will first receive a combination of chemotherapy and pembrolizumab for about 6 months, using specific chemotherapy drugs based on their cancer type. After this induction, patients showing disease control without severe side effects will be randomly assigned to one of two groups: continuing pembrolizumab (with or without pemetrexed for certain cancer types) for up to 2 years or observation (with or without pemetrexed). Researchers will monitor various factors including patient characteristics and tumor markers. During the study, participants will attend scheduled visits for treatment and monitoring, including imaging scans to measure tumor response and laboratory tests to check health status. Quality of life and survival will be tracked up to about 24 months after randomization. The study also collects data on side effects and progression-free survival to better understand the benefits and risks of shorter versus longer immunotherapy maintenance.
CONDITIONS
Brief 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
- Histologically or cytologically confirmed Stage IV NSCLC
- PD-L1 tumor content assessed locally
- ECOG Performance Status 0 or 1
- Weight loss less than 10% in past 3 months
- No prior systemic anticancer therapy for advanced disease
- Age 18 years or older and under 75 years
- Life expectancy greater than 3 months
- Measurable tumor by CT or MRI per 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 ≥ 9g/dL, liver enzymes and bilirubin within limits
- Women of childbearing potential and sexually active must use effective contraception and have negative pregnancy test
- Sexually active male subjects must use effective contraception
- Patient has national health insurance coverage
You will not qualify if you...
- Small cell lung cancer or mixed tumors with SCLC 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 treatment start except bone palliative radiotherapy
- Symptomatic untreated brain metastases without prior brain radiotherapy or surgery
- History of immunodeficiency, organ transplant needing immunosuppressants, recent immunosuppressive drugs, or severe immune toxicity from prior immunotherapy
- Systemic corticosteroids over 10 mg prednisone equivalent within 14 days before immunotherapy
- Active autoimmune diseases requiring systemic immunosuppression
- Active inflammatory intestinal diseases or serious chronic intestinal diseases with uncontrolled diarrhea
- Active uncontrolled infection including tuberculosis and acute viral hepatitis B or C
- Known HIV infection
- Live attenuated vaccine within 30 days prior
- 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 procedures
- Pregnant or breastfeeding women
- Patients deprived of liberty or unable to express will
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants receive first-line chemotherapy plus pembrolizumab to control their advanced lung cancer.
Every 3 weeks for chemotherapy and pembrolizumab infusions
Duration - Up to 2 years or until disease progression or unacceptable toxicity
Participants with disease control at 6 months are randomized to either continue pembrolizumab (with or without pemetrexed for non-squamous cell carcinoma) up to 2 years, or to observation (with or without pemetrexed for non-squamous cell carcinoma).
Pembrolizumab and pemetrexed visits every 3 weeks or observation visits depending on the arm
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
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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