Non Small Cell Lung Cancer Stage III Unresectable / CAPP-Seq technique / Durvalumab · Phase 2 Trial
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 2 trial (not yet recruiting) investigating whether MRD assessment via CAPP-Seq can guide personalized consolidation durvalumab therapy in stage III NSCLC, aiming to reduce overtreatment and toxicity compared to the standard 12-month fixed approach. No results are available from this registry record.
Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Non-small Cell Lung Cancer Stage III Unresectable; age from 18 Years. Intervention: Arm A : durvalumab; Arm B : durvalumab or no treatment. n = 177. 32 sites: France.
This is a planned Phase 2 trial (not yet recruiting) investigating whether MRD assessment via CAPP-Seq can guide personalized consolidation durvalumab therapy in stage III NSCLC, aiming to reduce overtreatment and toxicity compared to the standard 12-month fixed approach. No results are available from this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This trial addresses a significant gap in personalizing consolidation immunotherapy by using MRD to identify patients most likely to benefit from durvalumab while sparing others from unnecessary toxicity exposure. Results, when available, may shift practice from uniform 12-month consolidation to adaptive strategies.
This is a Phase 2 interventional trial registration with no results posted; it describes a planned study of personalized immunotherapy selection based on MRD detection in stage III NSCLC, addressing an important clinical question but carrying no outcome data.
As stated by the source record.
Quoted from the source exactly as published.
This trial addresses a significant gap in personalizing consolidation immunotherapy by using MRD to identify patients most likely to benefit from durvalumab while sparing others from unnecessary toxicity exposure. Results, when available, may shift practice from uniform 12-month consolidation to adaptive strategies.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07759492). This is a study registration, not published results. Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 177 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer Stage III Unresectable. Interventions: DIAGNOSTIC_TEST: CAPP-Seq technique; DRUG: Durvalumab. Primary outcome measures: To evaluate the efficacy of a personalized strategy of consolidation immunotherapy based on the assessment of MRD post-CRT in stage III NSCLC. , 12 months after randomisation.. Brief 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.
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