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Personnalized Immunotherapy in Patients With Stage III Non-small Cell Lung Cancer
Sponsor: Intergroupe Francophone de Cancerologie Thoracique
Summary
The reference treatment for locally advanced (stage III) non-small cell lung cancer (NSCLC) is concomitant chemoradiotherapy (CRT) followed by durvalumab consolidation for 1 year. This strategy is based on the results of the PACIFIC trial, which compared, in a randomized fashion after CRT, the superiority of treatment with durvalumab at a dose of 1500 mg every 4 weeks for 12 months to placebo in patients with non-progressive disease. The coprimary endpoints of this trial were progression-free survival (PFS) and overall survival (OS). This study was positive and showed a benefit in PFS and OS. However, less than half of patients (49%) received the full 12 months of durvalumab in this study, one-third of these discontinuations being related to toxicity. Furthermore, the prescription of durvalumab in this setting is not currently guided by any companion biomarker. As a result, the systematic prescription of a 12-month consolidation immunotherapy after CRT, without any selection criteria, leads to a possible overtreatment of patients whose survival would have been prolonged without additional treatment. These patients are systematically exposed to a potentially high and serious risk of toxicity in the course of immunotherapy. It is therefore crucial to move towards a more individualized approach in the prescription of consolidation immunotherapy after CRT in stage III NSCLC. This would ensure that the most appropriate treatment is delivered to patients who are likely to derive significant clinical benefit, while concurrently minimizing the exposure of other patients to potentially severe clinical toxicities. Additionally, such an approach would help protect healthcare systems from unnecessary economic burden, preventing the allocation of resources to treatments that offer limited therapeutic value.
Official title: ctDNA-guIDEd consolidATION Immunotherapy After Chemoradiotherapy in Patients With Stage III Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
177
Start Date
2026-11
Completion Date
2031-02
Last Updated
2026-08-12
Healthy Volunteers
No
Interventions
CAPP-Seq technique
Patients in Arm B will be divided into 2 groups : MRD positive and MRD negative depending on the result of the CAPP-Sequ technique.
Durvalumab
Patients in Arm A (non-comparative control) will receive durvalumab treatment. The patients in Arm B who are MRD positive (see CAPP-Seq technique intervention) will receive durvalumab treatment.
Locations (32)
Angers - CHU
Paris, France
Avignon - Institut du Cancer Avignon-Provence
Paris, France
Bordeaux - CHU
Paris, France
Bordeaux - Polyclinique
Paris, France
Boulogne - APHP Ambroise Paré
Paris, France
Brest - CHU
Paris, France
Caen - CHU
Paris, France
Chambéry - CH
Paris, France
Clermont-Ferrand - CHU
Paris, France
Colmar - CH
Paris, France
Grenoble - CHU
Paris, France
La Roche-Sur-Yon - CHD Vendée
Paris, France
Le Mans - CHG
Paris, France
Lille - Centre Oscar Lambret
Paris, France
Limoges - CHU
Paris, France
Lyon - HCL
Paris, France
Marseille - APHM Nord
Paris, France
Marseille - Institut Paoli-Calmettes
Paris, France
Montpellier - CHU
Paris, France
Morlaix - CH
Paris, France
Nantes - Institut de Cancérologie de l'Ouest
Paris, France
Paris - APHP Bichat
Paris, France
Paris - APHP Cochin
Paris, France
Paris - APHP Pitié-Salpêtrière
Paris, France
Paris - APHP Tenon
Paris, France
Paris - Saint Joseph
Paris, France
Poitiers - CHU
Paris, France
Reims - Institut Godinot
Paris, France
Toulon - Sainte Anne HIA
Paris, France
Tours - CHU
Paris, France
Vannes - Bretagne Atlantique
Paris, France
Villefranche sur Saône - CH
Paris, France