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MK 7339-013 - A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) - KEYLYNK-013

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

1. Has pathologically (histologically or cytologically) confirmed Small Cell Lung Cancer (SCLC). Note: Note: Participants with histology showing a mixed tumor with small cell and non-small cell elements are not eligible. 
2. Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses.
3. Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans
4. Has at least 1 lesion that meets the criteria for being measurable, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
5. Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC.
6. Is not expected to require tumor resection during the course of the study.
7. Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable.
8. Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention.
9. Has a life expectancy of at least 6 months.
10. Has adequate organ function.
11. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention.
12. Male and female participants who are at least 18 years of age at the time of signing the information consent.
13. Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention.               
14. Abstains from breastfeeding during the study intervention period and for at least the following period after the last study intervention:
    - Pembrolizumab: 120 days
    - Olaparib: 7 days.

Criteri di esclusione: 

1. Has history, current diagnosis, or features suggestive of myelodysplastic syndrome/ acute myeloid leukemia (MDS/AML).
2. Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PDL1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
3. Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
4. Had major surgery <4 weeks prior to the first dose of study intervention (except for placement of vascular access).
5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
8. Has severe hypersensitivity (≥ Grade 3) to study intervention and/or any of its excipients.
9. Has an active autoimmune disease that has required systemic treatment in past 2 years
10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids
11. Has an active infection requiring systemic therapy.
12. Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection.

Schema di trattamento: 

BIOLOGICAL: Pembrolizumab 200 mg
BIOLOGICAL: Pembrolizumab 400 mg
DRUG: Pembrolizumab placebo (saline)
DRUG: Pembrolizumab placebo (saline)
DRUG: Olaparib 300 mg BID
DRUG: Olaparib matching placebo
DRUG: Etoposide 100 mg/m^2
DRUG: Platinum, investigator's choice
RADIATION: Standard Thoracic Radiotherapy
RADIATION: Prophylactic Cranial Irradiation (PCI)

Trattamento sperimentale: 

- Group A - Pembrolizumab 200 mg
- Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID

Trattamento di controllo: 

Group C (Pembrolizumab and Olaparib Matching Placebos)

Centri partecipanti

Nord Italia

ASST Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS

Email: radioterapia@asst-spedalicivili.it

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
SS Oncologia Medica Toraco-Pomonare

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Prof. Filippo De Marinis
Telefono: 0257489773
Email: filippo.demarinis@ieo.it

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

Riferimento: Dr.ssa Alessandra Bulotta
Email: oncologia.medica@hsr.it

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO

Riferimento: Dr.ssa Federica Bertolini
Email: bertolini.federica@aou.mo.it

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
Oncologia Medica 2

Riferimento: Prof.ssa Valentina Guarneri
Telefono: 0498215931
Email: oncologia2@iov.veneto.it

 

AOUI Verona - Borgo Trento
Piazzale Aristide Stefani 1 - 37126 Verona - VR

Riferimento: Dr.ssa Jessica Menis
Email: jessica.menis@aovr.veneto.it

 

Centro Italia

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI

Riferimento: Prof. Lorenzo Livi
Email: rt.datamanager@sbsc.unifi.it

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM

Riferimento: Prof. Emilio Bria
Email: emilio.bria@policlinicogemelli.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-003616-31

Data di inserimento: 21.05.2021

Data di aggiornamento: 24.06.2024

Promotore

Merck Sharp & Dohme Corp.

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na

 

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