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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
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
Procedure/SurgerySurgical removal of the tumor in patients with resectable or borderline resectable NSCLC
Chemoradiotherapy
RadiationChemoradiotherapy
Immunotherapy
DrugImmunotherapy (Durvalumab).
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: Surgery + ImmunotherapyExperimental treatment 2 interventions
Group B: Chemoradiotherapy + ImmunotherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
2-Year Event-Free Survival (EFS) Rate in Patients with Resectable or Borderline Resectable NSCLC
2 year EFS rate is defined as percentage of patients without an event specified as relapse or progression according to RECIST 1.1 criteria, secondary tumor, or death of any cause, whichever occurs first, within 2 years after date of randomization.
Time frame
Within 2 years after date of randomizationSecondary outcomes
1
Analyze the health-related Quality of Life (QoL)
Changes in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 symptom scales from date of randomization through study completion (an average of 14 months after randomization) and changes in EORTC QLQ-C30 functional scales and global health status from date of randomization through study completion (an average of 14 months after randomization). Higher scores indicate a better outcome.
Time frame
from date of randomization through study completion (an average of 14 months after randomization)2
Analyze the health-related Quality of Life (QoL)
Changes in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) LC13 symptom scales from date of randomization through study completion (an average of 14 months after randomization). Higher scores indicate a better outcome.
Time frame
from date of randomization through study completion (an average of 14 months after randomization)3
Occurence of adverse events
Occurrence of adverse events according to CTCAE (V5.0): * adverse events grade ≥ 3 (according to NCI CTCAE v5.0) * SAEs * Unexpected AEs
Time frame
for 12 months according to arm4
Efficacy of multimodality treatment
Efficacy will be assessed in terms of Overall survival (OS) defined as time from randomization until death due to any cause
Time frame
From Randomization to death from any cause, within 2 years after date of randomization or throughout extended follow-upOther outcomes
1
Radiological response including radiomics in irradiated patients.
Assessment of correlation of radiomic features with the treatment response (only for patients in the chemoradiation arm)
Time frame
from randomization into arm 2 (chemoradiotherapy) till study completion (an average of 14 months after randomization) or throughout extended follow-up2
Training and evaluation of deep learning algorithms for automated response prediction
compared with physician-assessed response evaluation
Time frame
from enrollment till study completion (an average of 17 months after enrollment) or throughout extended follow-up3
Training and evaluation of deep learning algorithms for automated assessment of Tumor Progression Patterns
compared with physician-assessed Tumor Progression Patterns
Time frame
from enrollment till study completion (an average of 17 months after enrollment) or throughout extended follow-up4
Assessment of blood samples for ctDNA and plasma proteomics
Assessment of amount of ctDNA and further analysis including sequencing, characterization and quantification of plasma proteins
Time frame
from enrollment till study completion (an average of 17 months after enrollment) or throughout extended follow-upSponsors and contacts
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Source ClinicalTrials.gov