Immunotherapy, Chemotherapy, Radiotherapy and Surgery for Synchronous Oligo-metastatic NSCLC

PHASE2RecruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

November 19, 2019

Primary Completion Date

August 31, 2026

Study Completion Date

December 31, 2026

Conditions
Non-small Cell Lung CancerStage IVOligometastasis
Interventions
DRUG

Durvalumab

Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1. Durvalumab is expected to stimulate the patient's antitumour immune response by binding to PD L1 and shifting the balance toward an antitumour response.

DRUG

Carboplatin

Carboplatin belongs to the group of medicines known as alkylating agents. Carboplatin interferes with the growth of cancer cells, which eventually are destroyed.

DRUG

Paclitaxel

A compound extracted from the Pacific yew tree Taxus brevifolia with antineoplastic activity. Paclitaxel binds to tubulin and inhibits the disassembly of microtubules, thereby resulting in the inhibition of cell division. This agent also induces apoptosis by binding to and blocking the function of the apoptosis inhibitor protein Bcl-2 (B-cell Leukemia 2).

RADIATION

Stereotactic body radiation therapy (SBRT)

SBRT of all oligo-metastatic lesions

PROCEDURE

Surgical resection - definitive local treatment.

Surgical resection of primary tumour for patients with single station, non-bulky tumours.

RADIATION

Radical radiotherapy - definitive local treatment.

Conventional or moderately hypo-fractionated radiotherapy to the primary tumour for other tumour stages, or in case of medical inoperability.

DRUG

Tremelimumab

Tremelimumab is a human mAb of the IgG 2 subclass that is directed against CTLA-4 (CD152), a cell surface receptor that is expressed primarily on activated T-cells and acts to inhibit their activation. Tremelimumab completely blocks the interaction of human CTLA-4 with CD80 and CD86, resulting in increased release of cytokines (interleukin-2 and IFN-γ) from human T-cells, peripheral blood mononuclear cells and whole blood.

Trial Locations (15)

Unknown

RECRUITING

European Institute of Oncology, Milan

RECRUITING

Istituto Oncologico Veneto - Irccs, Padua

RECRUITING

IRCCS Istituto Nazionale Tumori Regina Elena, Roma

RECRUITING

Maastricht University Medical Center, Maastricht

RECRUITING

Erasmus Medical Centre, Rotterdam

RECRUITING

Hosp. De la Santa Creu i Sant Pau, Barcelona

RECRUITING

Hosp. Uni. Virgen de las Nieves, Granada

RECRUITING

Hosp. Sanchinarro- Centro Integral Oncología Clara Campal, Madrid

RECRUITING

Vall d'Hebron University Hospital, Madrid

RECRUITING

Hosp. Uni. Politécnico La Fe, Valencia

RECRUITING

Inselspital Bern, Bern

RECRUITING

Geneva University Hospital, Geneva

ACTIVE_NOT_RECRUITING

Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

RECRUITING

Kantonsspital Winterthur, Winterthur

RECRUITING

University Hospital Zurich, Zurich

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

ETOP IBCSG Partners Foundation

NETWORK