Immunochemotherapy, Surgery or Chemoradiation, and Durvalumab for Stage IIIA/B NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorUniversity Hospital, Bonn
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
- Chemoradiotherapy
- Immunotherapy
Treatment groups
176 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov