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

CHESS: Immunotherapy, chemotherapy, radiotherapy and surgery for synchronous oligo-metastatic NSCLC

Immunotherapy has substantially improved the outcome in metastatic NSCLC and has become first-line treatment of choice in patients with high PD-L1 expression and without EGFR or ALK mutations. However, only about one-third of NSCLC patients present a PD-L1 expression of ‚Č•50%, excluding most patients from first-line immunotherapy. Various strategies are currently pursued to increase the number of patients that may benefit from immunotherapy and to further improve the outcome of patients with metastatic NSCLC.

The CHESS trial builds on encouraging data from combined chemo-radiotherapy with immune-checkpoint inhibitors and  the excellent local control provided by radiotherapy and surgery.

Trial Scheme

Trial Information

Primary Endpoint:
Progression-free survival at 12 months
Secondary Endpoints:
Overall survival
Pattern of disease progression
Distant progression-free survival
Response to induction therapy
Overall response
Duration of response
Toxicity before and after surgery/radiotherapy
Symptom-specific and global quality of life
Target Sample Size:
47 patients
Protocol Release Date cohort 1:
25 April 2019
Protocol Release Date cohort 2:
02 June 2023
Trial Activation Date:
05 September 2019
First Patient In:
19 November 2019

Trial Organisation

Trial Chair:
Matthias Guckenberger
Trial Co-Chair:
Isabelle Schmitt-Opitz
Sponsor:
ETOP IBCSG Partners Foundation
Coordinating Group:
ETOP IBCSG Partners Foundation
Participating Groups:
Swiss Group for Clinical Cancer Research (SAKK) and Spanish Lung Cancer Group (SLCG)
Participating Countries:
Italy, Netherlands, Spain, Switzerland
Registrations:
EudraCT number: 2018-003011-22
ClinicalTrials.gov: NCT03965468

Contact

ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
CHESS@etop.ibcsg.org

 

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