European Institute of Oncology Milano ItalyAktiv, nicht rekrutierend» Google-MapsIstituto Oncologico Veneto - Irccs Padova ItalyAktiv, nicht rekrutierend» Google-MapsMaastricht University Medical Center Maastricht NetherlandsAktiv, nicht rekrutierend» Google-Maps
Erasmus Medical Centre Rotterdam NetherlandsAktiv, nicht rekrutierend» Google-MapsHosp. De la Santa Creu i Sant Pau Barcelona SpainRekrutierend» Google-Maps Ansprechpartner: Andrés Barba, MD» Ansprechpartner anzeigenHosp. Uni. Virgen de las Nieves Granada SpainRekrutierend» Google-Maps Ansprechpartner: Javier Valdivia, MD» Ansprechpartner anzeigenHosp. Sanchinarro- Centro Integral Oncología Clara Campal Madrid SpainRekrutierend» Google-Maps Ansprechpartner: Gema García Ledo, MD» Ansprechpartner anzeigenVall d'Hebron University Hospital Madrid SpainRekrutierend» Google-Maps Ansprechpartner: Augusto Valdivia, MD» Ansprechpartner anzeigenHosp. Uni. Politécnico La Fe Valencia SpainRekrutierend» Google-Maps Ansprechpartner: Oscar Juan-Vidal, MD» Ansprechpartner anzeigenInselspital Bern Bern SwitzerlandRekrutierend» Google-Maps Ansprechpartner: Ferdinando Cerciello, MD E-Mail: ferdinando.cerciello@insel.ch» Ansprechpartner anzeigenGeneva University Hospital Geneva SwitzerlandRekrutierend» Google-Maps Ansprechpartner: Alfredo Addeo, MD E-Mail: alfredo.addeo@hcuge.ch» Ansprechpartner anzeigenCentre Hospitalier Universitaire Vaudois (CHUV) Lausanne SwitzerlandAktiv, nicht rekrutierend» Google-MapsUniversity Hospital Zurich Zurich SwitzerlandRekrutierend» Google-Maps Ansprechpartner: Matthias Guckenberger, MD E-Mail: Matthias.Guckenberger@usz.ch» Ansprechpartner anzeigen
1. Progression-free survival at 12 months (Time Frame - Assessed from the date of enrolment to completion of treatment at 12 months.): The PFS rate at 1-year is the primary endpoint of this trial and it is defined as the rate of patients without a PFS event at 1-year after enrolment. The rate will be estimated as the percentage of patients without a PFS event over the total number of patients who have completed a 1-year follow-up period after the enrolment. PFS is defined as the time from the date of enrolment until documented progression or death, if progression is not documented. Progression is defined as the development of new metastatic lesions or local progression of resected or irradiated metastases or primary tumour, assessed according to RECIST criteria version 1.1
Secondary outcome:
1. Overall survival (Time Frame - Time from date of enrolment until death from any cause. Assessed for up to 30 months.): Overall survival (OS) is defined as the time from the date of enrolment until death from any cause. Censoring for OS (patients without reported death) will occur at the last follow-up date.
2. Pattern of disease progression (Time Frame - Assessed from the date of enrolment until progression, from enrolment up to 12 months.): Defined as the site of first progression. None, locoregional, distant, or both locoregional and distant.
3. Response to induction therapy (Time Frame - Assessed from the start of protocol treatment until the 3-month restaging): Defined as the best overall response [complete response (CR) or partial response (PR)] according to RECIST 1.1 criteria.
4. Distant progression-free survival (Time Frame - Assessed from the date of enrolment for up to 12 months.): Defined as the date of development of new metastases, excluding oligometastasis diagnosed at enrolment.
5. Overall response (Time Frame - Assessed from the start of protocol treatment across all time points until the end of follow-up, assessed for up to 30 months.): Defined as best overall response [complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.
6. Duration of response (Time Frame - Assessed from the date of enrolment for up to 12 months.): Defined as the interval from the date of first documentation of objective response (CR or PR), according to RECIST 1.1 criteria to the date of first documented progression, relapse or death from any cause.
7. Symptom-specific and global quality of life: The Lung Cancer Symptom Scale (Time Frame - Assessed at trial entry, until 6 months after treatment start and at 12 months from enrolment.): The Lung Cancer Symptom Scale, a 9-item one page questionnaire will be used to assess change in total score (average of all 9 items).
8. Toxicity before and after surgery/radiotherapy (Time Frame - Adverse events will be collected from the date of consent until 90 days after the completion of treatment.): Safety parameters will be assessed in terms of adverse events graded by CTCAE v5.0 including events leading to dose interruptions, withdrawals of protocol treatment and death; severe, serious and selected adverse events; deaths; clinically significant laboratory parameters and abnormalities, and vital signs.
Durvalumab (Imfinzi): 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.
Carboplatin: Carboplatin belongs to the group of medicines known as alkylating agents. Carboplatin interferes with the growth of cancer cells, which eventually are destroyed.
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).
Stereotactic body radiation therapy (SBRT): SBRT of all oligo-metastatic lesions
Surgical resection - definitive local treatment.: Surgical resection of primary tumour for patients with single station, non-bulky tumours.
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.
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.
Quelle: ClinicalTrials.gov
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