Patologia: Neoplasie del polmone
Fase di studio: III
Richiesta mandatoria di tessuto: Sì
Linee di trattamento: Adiuvante/neoadiuvante
Criteri di inclusione:
- Have previously untreated, histologically confirmed NSCLC and histologically confirmed Stage IIB or IIIA NSCLC.
- Be able to undergo protocol therapy, including necessary surgery.
- If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm for at least 180 days after the last dose of study treatment.
- If female, may participate if not pregnant, not breastfeeding, and at least one of the following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 180 days after the last dose of study treatment.
- Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for submission. If blocks are not available, have unstained slides for submission for central programmed death-ligand 1 (PD-L1) testing.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days of randomization.
- Have adequate organ function
Criteri di esclusione:
- A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment.
- Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus; 2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor.
- Has a history of (non-infectious) pneumonitis /interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids.
- Has an active infection requiring systemic therapy.
- Has had an allogenic tissue/sold organ transplant.
- Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients.
- Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and/or to any of their excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known history of Hepatitis B or Hepatitis C.
- Has a known history of active tuberculosis.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate.
- Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor.
- Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation.
- Has received prior radiotherapy within 2 weeks of start of trial treatment.
- Has received a live vaccine within 30 days prior to the first dose of trial drug.
- Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.
- Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug.
- Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of trial treatment.
Trattamento di controllo:
NAC + Neoadjuvant/Adjuvant Placebo
Obiettivi primari dello studio:
1.Event Free Survival (EFS) [Time Frame: Up to 5 years]
EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by blinded central pathologist or by imaging using RECIST 1.1 assessed by BICR.
2.Overall Survival (OS) [Time Frame: Up to 5 years]
OS is defined as the time from randomization until death from any cause.
Azienda Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS
Riferimento: Dr.ssa Elisa Roca
IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
Riferimento: Dr.ssa Marina Chiara Garassino
Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Riferimento: Dr. Luca Gianni
A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB
Riferimento: Dr. Diego Cortinovis
Azienda Ospedaliera San Camillo Forlanini
Via Portuense 332 - 00149 Roma - RM
Riferimento: Dr.ssa Maria Rita Migliorino
Azienda Ospedaliera Vincenzo Monaldi
Via Leonardo Bianchi 1 - 80131 Napoli - NA
Riferimento: Dr. Francovito Piantedosi
Numero di iscrizione a registro: 2017-001832-21
Data di inserimento: 22.11.2018
Data di aggiornamento: 11.02.2019
Fondazione IRCCS, Istituto Nazionale dei Tumori, Milano
Riferimento: Dr.ssa Marina Chiara Garassino