MedTrace Logo

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

NCT07759492 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

  • Non-small Cell Lung Cancer Stage III Unresectable

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.

Sponsors & Collaborators

  • Intergroupe Francophone de Cancerologie Thoracique

    lead OTHER

Principal Investigators

  • Etienne GIROUX-LEPRIEUR, MD, PhD · Cancer Institute APHP. Université Paris-Saclay, APHP - Hôpital Ambroise Paré

  • Benoit Roch, MD · Arnaud de Villeneuve Hospital - University Hospital of Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2030-11-30
Completion
2031-02-28

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07759492 on ClinicalTrials.gov