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 ≥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

ETOP CHESS Trial Schema v10

 

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: 25 April 2019
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
Coordinating Group: ETOP IBCSG Partners
Participating Groups: SAKK and SLCG
Participating Countries:
Italy, The Netherlands, Spain, and Switzerland
Registrations:

EudraCT number: 2018-003011-22

ClinicalTrials.gov: NCT03965468

 

Contact

Robin Schweri (Trial Manager)

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ETOP IBCSG Partners Foundation

Effingerstrasse 33

3008 Bern, Switzerland