Phase-II Trial of Induction Chemotherapy and Chemoradiotherapy Plus/Minus Durvalumab and Consolidation Immunotherapy in Patients With Resectable Stage III NSCLC.

NCT04202809 | Unknown Phase 2

• 1 other identifier: ESPADURVA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 7

Brief Summary

To compare a complex induction multimodality protocol (ESPATUE) + concurrent immunotherapy with PD-L1 antibody Durvalumab given every three weeks to the same induction multimodality protocol without Durvalumab immunotherapy induction followed by definitive local treatment (surgery for those considered resectable or chemoradiation boost for those not considered to be R0-resectable) followed by consolidation Durvalumab treatment in both arms.

Conditions

NSCLC, Stage III

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Two-year progression-free survival rate

  2 years

Secondary Outcomes (8)

• Overall survival

  after 1, 2, 3, 4 and 5 years

• 2-y-overall survival rate

  2 years

• Functional response

  Week 15

• RECIST response (induction)

  Week 9

• RECIST criteria

  Through study completion, an average of every 2 months for up to 11 months

Study Arms (2)

Chemo- and Radiochemotherapy + Durvalumab

EXPERIMENTAL

Drug: Durvalumab

Chemo- and Radiochemotherapy

NO INTERVENTION

Interventions

Durvalumab DRUG

Durvalumab is given earlier as registered, during chemotherapy and radiotherapy in treatment Arm A

Chemo- and Radiochemotherapy + Durvalumab

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body weight \>30 kg
• Age ≥ 18 years and \< 75 years
• Male or female patients. Female (as well as male) patients have to take care of effective measures of anticonception
• Histologically proven non-small cell lung cancer
• Selected patients with non-small cell lung cancer stages IIIA and IIIB:
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Fulfillment 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)
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g, European Union \[EU\] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• Must have a life expectancy of \> 12 weeks
• Adequate normal organ and marrow function
• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
• Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
• Stable cardiac function (no Myocardial infarction (MI) within 6 months, no heart failure according to New York Heart Association (NYHA) III-IV).

You may not qualify if:

• resectable IIB or selected IIIA (T3N0; T3N1)
• unresectable disease pre-treatment
• mixed histology with areas of small cell carcinoma (neuroendocrine markers)
• clinically symptomatic vena cava superior syndrome
• diffuse mediastinal involvement
• patients with T3N3 and T4N3 tumors (IIIC according to International Association for the Study of Lung Cancer (IASLC)/Union Internationale Contre le Cancer (UICC) 8)
• invasion of the thoracic aorta (T4 - aorta)
• invasion of the heart (except left atrium - T4 - heart)
• invasion of the esophagus (T4 - esophagus)
• invasion of spine (T4 - spine)
• (full blown) Pancoast-syndrome in tumors of the superior sulcus (T3-4 Nx)
• malignant (positive) pericardial effusion (M1a - pericardial effusion)
• malignant (positive) pleural effusion (M1a - pleural effusion)
• involvement of the contralateral hilar nodes (if any data available)
• endobronchial tumor extension to the contralateral main stem bronchus

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (7)

Klinikum rechts der Isar - Technische Universität München

Munich, Bavaria, 81675, Germany

RECRUITING

Universitätsklinikum Essen

Essen, 45147, Germany

RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH

Hemer, 58675, Germany

RECRUITING

Pius-Hospital Oldenburg

Oldenburg, 26121, Germany

RECRUITING

Universitätsklinikum Regensburg

Regensburg, 93042, Germany

RECRUITING

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wilfried Eberhardt, PD MD

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Moell, PhD

CONTACT

0049 201 72377412; andrea.moell@uk-essen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 18, 2019
• Study Start: January 13, 2020
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)