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Dex2 / Non Small Cell Lung Cancer · Phase 2 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 clinical trial registry record for a dendritic cell-derived exosome vaccine (Dex) combined with metronomic cyclophosphamide in patients with advanced non-small-cell lung cancer who responded to or stabilized on induction chemotherapy. The study has completed recruitment but no efficacy or safety results are posted in this registry record; the trial cannot be evaluated for clinical impact.
Phase 2, Interventional, Single Group, Open label, Treatment purpose. Non Small Cell Lung Cancer; age from 18 Years; to 70 Years. Intervention: Dex2. n = 41. 1 site: France.
This is a Phase 2 clinical trial registry record for a dendritic cell-derived exosome vaccine (Dex) combined with metronomic cyclophosphamide in patients with advanced non-small-cell lung cancer who responded to or stabilized on induction chemotherapy. The study has completed recruitment but no efficacy or safety results are posted in this registry record; the trial cannot be evaluated for clinical impact.
Outcomes for safety, tolerability, immune response, and progression-free survival at 4 months are not reported in this record.
The source did not state who this applies to in practice.
Phase 2 trial of an experimental immunotherapy in non-small-cell lung cancer, completed but with no results reported in this registry record; cannot assess efficacy or safety.
As stated by the source record.
Quoted from the source exactly as published.
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 (NCT01159288). This is a study registration, not published results. Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 41 participants (ACTUAL). Conditions: Non Small Cell Lung Cancer. Interventions: BIOLOGICAL: Dex2. Primary outcome measures: Progression free survival , 4 months. Brief summary: Lung cancer is the worldwide leading cause of cancer death. In France, with 28,000 new cases per year, lung cancer is the 4th in terms of incidence but remains the leading cause of cancer death. The 5-year survival of lung cancer, all stages and all types, is very low, estimated at 12% among men and 16% among women in France. In advanced unresectable non small cell lung cancer, standard treatment relies on platinum-based induction chemotherapy. The median progression-free survival (PFS) in patients responding or stabilized after 4 chemotherapy cycles ranges from 2 to 2.8 months. Gustave Roussy and Curie institutes have developed an immunotherapy involving metronomic cyclophosphamide (mCTX) followed by vaccinations with tumor antigen-loaded dendritic cell-derived exosomes (Dex). mCTX inhibits Treg functions restoring T and NK cell effector functions and Dex are able to activate the innate and adaptive immunity. Phase I trials showed the safety and feasibility of Dex vaccines but no induction of T cells could be monitored in patients. Since 2007, we validated a new process for isolation of second generation Dex with improved immune stimulatory capacities. We propose a maintenance immunotherapy in 47 advanced unresectable NSCLC patients responding or stabilized after induction chemotherapy with Dex-based treatment to improve PFS rate at 4 months in these patients.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.