A Multicentre Single Arm Phase II Trial Assessing the Efficacy of Immunotherapy, Chemotherapy and Stereotactic Radiotherapy to Metastases Followed by Definitive Surgery or Radiotherapy to the Primary Tumour, in Patients With Synchronous Oligo-metastatic Non-small Cell Lung Cancer

Who is this study for? Patients with histologically-confirmed synchronous oligo-metastatic non-small cell lung cancer
What treatments are being studied? Durvalumab+Carboplatin+Paclitaxel+Stereotactic body radiation therapy+Surgical resection+Radical radiotherapy
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug, Procedure, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

A multicentre single arm phase II trial assessing the efficacy of immunotherapy, chemotherapy plus stereotactic radiotherapy to metastases followed by definitive surgery or radiotherapy to the locoregional primary tumour, in patients with histologically-confirmed synchronous oligo-metastatic non-small cell lung cancer (NSCLC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed non-small cell lung cancer

• Synchronous oligo-metastatic stage IV disease: maximum of three distant metastases, one of which must be extra-cerebral for stereotactic body radiotherapy (SBRT); Initial mediastinal staging is recommended (except for lymph nodes \<1 cm on CT and PET-negative) preferentially by endobronchial ultrasound (EBUS); Neurosurgical resection of one single central nervous system (CNS) metastasis or laparoscopic resection of one adrenal metastasis before study inclusion is allowed (one extra-cerebral metastasis must be available for SBRT)

• Able to understand and give written informed consent and comply with study procedures

• Age ≥18 years

• ECOG Performance Status 0-1

• Availability of tumour tissue for translational research

• Adequate haematological, renal and liver function

Locations
Other Locations
Italy
European Institute of Oncology
RECRUITING
Milan
Istituto Oncologico Veneto - Irccs
RECRUITING
Padua
IRCCS Istituto Nazionale Tumori Regina Elena
RECRUITING
Roma
Netherlands
Maastricht University Medical Center
RECRUITING
Maastricht
Erasmus Medical Centre
RECRUITING
Rotterdam
Spain
Hosp. De la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hosp. Uni. Virgen de las Nieves
RECRUITING
Granada
Hosp. Sanchinarro- Centro Integral Oncología Clara Campal
RECRUITING
Madrid
Vall d'Hebron University Hospital
RECRUITING
Madrid
Hosp. Uni. Politécnico La Fe
RECRUITING
Valencia
Switzerland
Inselspital Bern
RECRUITING
Bern
Geneva University Hospital
RECRUITING
Geneva
Centre Hospitalier Universitaire Vaudois (CHUV)
ACTIVE_NOT_RECRUITING
Lausanne
Kantonsspital Winterthur
RECRUITING
Winterthur
University Hospital Zurich
RECRUITING
Zurich
Contact Information
Primary
Barbara Ruepp, PharmD
barbara.ruepp@etop.ibcsg.org
+41315119400
Backup
Susanne Roux
CHESS@etop.ibcsg.org
+41315119400
Time Frame
Start Date: 2019-11-19
Estimated Completion Date: 2026-12
Participants
Target number of participants: 96
Treatments
Experimental: Immunotherapy, chemotherapy, radiotherapy and surgery
Durvalumab 1500 mg administered intravenously every 3 weeks for the first 4-6 cycles (during chemotherapy);~Tremelimumab 75mg administered intravenously every 3 weeks for the first 4-6 cycles (only cohort 2)~4-6 cycles of chemotherapy, carboplatin AUC5 every 3 weeks plus paclitaxel 175 mg/m2, every 3 weeks;~Stereotactic body radiotherapy (SBRT) of all oligo-metastatic lesions, in a maximum of 10 treatment fractions over 2 weeks, starting after week one of chemotherapy cycle 1 and completed within four weeks after start of durvalumab treatment;~Restaging at 3 months; if no disease progression, proceed to definitive local treatment (surgical resection of primary tumour or radiotherapy at a minimum dose of 60-66Gy to the primary tumour). Durvalumab continues at 1500 mg intravenously every 4 weeks until progression of disease or for a maximum of 1 year from start of treatment.
Sponsors
Leads: ETOP IBCSG Partners Foundation
Collaborators: AstraZeneca

This content was sourced from clinicaltrials.gov

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