Immunochemotherapy, Surgery or Chemoradiation, and Durvalumab for Stage IIIA/B NSCLC (NCT06810609) | Clinical Trial Compass
RecruitingPhase 2
Immunochemotherapy, Surgery or Chemoradiation, and Durvalumab for Stage IIIA/B NSCLC
Germany176 participantsStarted 2025-04-20
Plain-language summary
The hypothesis of the study is that induction immunochemotherapy, followed by surgery or chemoradiation and consolidation Durvalumab immunotherapy, can significantly improve event-free survival in patients with resectable or borderline resectable NSCLC at stage IIIA/B compared to existing treatment methods.
Who can participate
Age range18 Years – 74 Years
SexALL
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Inclusion criteria
✓. IIIA: one or more lymph node levels involved at EBUS/mediastinoscopy T1/T2 N2.
✓. IIIB: one or more lymph node levels involved at EBUS/mediastinoscopy T3/T4 N2. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 10. Given technical/oncologic complete resectability (R0) at the time of inclusion. 11. Sufficient functional reserves for the planned surgery 12. Fulfilment of adequate criteria for functional and medical resectability as described in the European Respiratory Society (ERS)/ European Society of Thoracic Surgeons (ESTS) guidelines (Brunelli et al. 2009) and acceptable general clinical condition for multimodality treatment (interdisciplinary committee).
✓. Given technical/oncologic complete resectability (R0) at the time of randomization.
✓. Sufficient functional reserves for the planned surgery
✓. Adequate normal organ and bone marrow function as defined before
Exclusion criteria
✕. Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
✕. All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.
✕. Must not have experienced a ≥ Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy.
✕. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \> 10 mg prednisone or equivalent per day.
What they're measuring
1
2-Year Event-Free Survival (EFS) Rate in Patients with Resectable or Borderline Resectable NSCLC
Timeframe: Within 2 years after date of randomization
✕. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
✕. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
✕. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 29. Current or prior use of immunostimulatory agents within 14 days before the first dose of durvalumab 30. Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 90 days after the last dose of study treatment.