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NOT YET RECRUITING
NCT07759492
PHASE2

Personnalized Immunotherapy in Patients With Stage III Non-small Cell Lung Cancer

Sponsor: Intergroupe Francophone de Cancerologie Thoracique

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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.

DRUG

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