OMEGA, Local Ablative Therapy in Oligometastatic NSCLC

Summary

Oligometastatic lung cancer (OM-NSCLC) seems to be associated with a better prognosis than usual Stage IV non-small cell lung cancer when radical local therapy of all metastatic sites is administered but the impact of such an approach on overall survival and quality of life remains to be defined by adequately powered phase III trials.

A consortium of tertiary referral centres involved in Lung Cancer management at the national level was established to launch a randomized trial of local ablative therapy in OM-NSCLC patients with potentially resectable or locally controlled primary tumors has been designed.

Inclusion criteria include adequate performance status, primary tumor controlled or controllable staging with whole-body FDG PET scan and brain MRI, fit to receive at least 3 cycles of platinum-based doublet chemotherapy, or immunotherapy or targeted agents according to molecular profile.

Exclusion criteria include cerebral oligometastasis alone (will receive local therapy in any case), metastasis in sites where normal radiotherapy constraints cannot be met, multiple subsolid nodules in the absence of extrapulmonary metastasis, prior malignant tumor with some exceptions, relevant co-morbidities that would significantly reduce life expectancy on their own.

Patients with synchronous or metachronous oligometastatic lung cancer (1-3 metastatic lesions) will be randomized to local ablative therapy + standard treatment Vs. standard treatment. Balancing between study arms will be performed according to synchronous vs. metachronous presentation, Number of oligometastases, Nodal status and Oncogene-addiction or PDL-1 expression. Primary outcome will be Overall Survival (OS) from randomization. The sample size is set to 195 patients.

Disease state and life status will be assessed on a 3-monthly basis by physical examination, whole-body CT scan plus repeat PET-scan if needed and Brain MRI if brain metastasis at enrolment. Toxicity and adverse events will be assessed according to NCI-Common Terminology Criteria. And RTOG criteria. Quality of life will be assessed at randomization and after six months by the SF36/LCSS

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

PROCEDURE

Surgical removal of primary and/or of all oligometastases

Standard lobectomy or segmentectomy if tumor resectable without pneumonectomy (prefer lobectomy if cardiorespiratory function is not or only moderately compromised, prefer segmentectomy if primary tumor less than 2 cm or cardiorespiratory function is more than moderately compromised but still permissive) Mediastinal lymph node dissection (at least 8 lymphnodes from at least 3 stations including station 7).

RADIATION

Non-surgical LAT

Non-surgical LAT may be carried out either by SABR or SBRT or RFA according to site of metastasis, local expertise and availability of resources.

DRUG

Standard medical therapy

platinum-based doublet according to local protocols or targeted agents according to EGFR/ALK/ROS-1 mutational status or immunotherapy agents according to PDL1 expression.

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza - Molinette Hospital

  collaborator OTHER

• San Luigi Gonzaga Hospital

  collaborator OTHER

• Regina Elena Cancer Institute

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• Azienda Ospedaliera San Camillo Forlanini

  collaborator OTHER

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  collaborator OTHER

• Humanitas Research Hospital IRCCS, Rozzano-Milan

  collaborator OTHER

• Azienda Ospedaliera Universitaria Integrata Verona

  lead OTHER

Principal Investigators

• Maurizio V Infante · Azienda Ospedaliera Universitaria Integrata Verona

• Michele Milella, PhD · Azienda Ospedaliera Universitaria Integrata Verona

• Emilio Bria, PhD · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-01

Primary Completion

2022-03-31

Completion

2022-09-30

Countries

• Italy

Study Locations