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Studies

Interventional Recruiting Phase 2

NCT06663098 on ClinicalTrials.gov

Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC).

Official title: Continued PD-L1 Inhibition With Atezolizumab With Rechallenge Chemotherapy in Patients With Sensitive Relapse SCLC Progressing on First-line Platinum-etoposide Chemotherapy and a PD-L1 Inhibitor: CARRY-ON Study-GOIRC-01-2023

  • Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
  • Collaborators: Roche Pharma AG
  • Enrollment: 142 (Estimated)
  • Study start: 2025-01-24 (Actual)
  • Primary completion: 2028-08-30 (Estimated)
  • Study completion: 2029-06-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

The goal of this clinical trial is to learn if a combination of atezolizumab and standard chemotherapy works to treat sensitive Extensive-stage Small Cell Lung Cancer, progressing after first-line of treatment.

The main questions it aims to answer are:

* Does combination of atezolizumab and standard chemotherapy increase overall survival?
* What medical problems do participants have when taking combination of atezolizumab and standard chemotherapy?

Participants will:

* take atezolizumab and standard chemotherapy every 3 weeks for 4 cycles and than atezolizumab every 3 weeks up to 18 cycles.
* visit the clinic once every 3 weeks for checkups and tests
* perform Radiological assessments after 6 weeks and then every 12 weeks to determine response to treatment.

Conditions

  • Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Intervention / Treatment

  • Drug: Atezolizumab
  • Drug: Carboplatin
  • Drug: Etoposide

Primary Outcome Measures

  • overall survival (through study completion, an average of 1 year)
    overall survival (OS), defined as the time from the date of registration to the date of death from any cause. Patients still alive at the time of analysis are censored at the last time they are known to be alive.

Countries

Italy

Locations and Investigators

  • Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano (PN), Italy (Not yet recruiting)
    • Alessandro Del Conte, MD
    • Alessandro Del Conte (Principal Investigator)
  • IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy (Not yet recruiting)
    • Vito Longo, MD
    • Vito Longo (Principal Investigator)
  • IRCCS Azienda Ospedaliero_Universitaria di Bologna, Bologna, Italy (Recruiting)
    • Andrea Ardizzoni, MD
  • UOC Medicina Oncologica, Carpi, Italy (Not yet recruiting)
    • Donatella Giardina, MD
    • Donatella Giardina (Principal Investigator)
  • ASST Cremona, Cremona, Italy (Not yet recruiting)
    • Matteo Brighenti, MD
    • Matteo Brighenti (Principal Investigator)
  • Azienda Ospedaliera S. Croce e Carle di Cuneo, Cuneo, Italy (Not yet recruiting)
    • Ida Colantonio, MD
    • Ida Colantonio (Principal Investigator)
  • AOU Careggi, Firenze, Italy (Not yet recruiting)
    • Francesca Mazzoni
    • Francesca Mazzoni (Principal Investigator)
  • Azienda USL Toscana nord-ovest Ospedale Versilia, Lido Di Camaiore, Italy (Recruiting)
    • Andrea Camerino, MD
  • Azienda USL Toscana Nord Ovest - Ospedale San Luca, Lucca, Italy (Not yet recruiting)
    • Editta Baldini, MD
    • Editta Baldini (Principal Investigator)
  • Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (IRST) "Dino Amadori", Meldola (FC), Italy (Not yet recruiting)
    • Angelo Delmonte, MD
    • Angelo Delmonte (Principal Investigator)
  • IRCCS Ospedale San Raffaele, Milano, Italy (Not yet recruiting)
    • Roberto Ferrara, MD
    • Roberto Ferrara (Principal Investigator)
  • AOU Policlinico di Modena, Modena, Italy (Not yet recruiting)
    • Federica Bertolini, MD
  • ASST San Gerardo dei Tintori Foundation, Monza, Italy (Not yet recruiting)
    • Diego L Cortinovis, MD
    • Diego Luigi Cortinovis (Principal Investigator)
  • AORN A. Cardarelli, Napoli, Italy (Not yet recruiting)
    • Ferdinando Riccardi, MD
    • Ferdinando Cardarelli (Principal Investigator)
  • AOU San Luigi Gonzaga, Orbassano (TO), Italy (Not yet recruiting)
    • Enrica Capelletto, MD
  • Istituto Oncologico Veneto, Padova, Italy (Not yet recruiting)
    • Giulia Pasello, MD
    • Giulia Pasello (Principal Investigator)
  • UOC di Oncologia Medica, Parma, Italy (Not yet recruiting)
    • Alessandro Leonetti, MD
    • Alessandro Leonetti (Principal Investigator)
  • Azienda Ospedaliera Santa Maria della Misericordia, Perugia, Italy (Not yet recruiting)
    • Giulio Metro, MD
    • Giulio Metro (Principal Investigator)
  • Azienda USL IRCCS di Reggio Emilia, Reggio Emilia, Italy (Not yet recruiting)
    • Maria Pagano, MD
    • Maria Pagano (Principal Investigator)
  • Istituto Nazionale Tumori Regina Elena, Roma, Italy (Not yet recruiting)
    • Fabiana L Cecere, MD
    • Fabiana Letizia Cecere (Principal Investigator)
  • Fondazione Policlinico Universitario A.Gemelli IRCCS - Università Cattolica del Sacro Cuore, Roma, Italy (Not yet recruiting)
    • Emilio Bria, MD
    • Emilio Bria (Principal Investigator)
  • AOU Sassari, Sassari, Italy (Not yet recruiting)
    • Antonio Pazzola, MD
    • Antonio Pazzola (Principal Investigator)
  • Azienda Ospedaliera Santa Maria di Terni, Terni, Italy (Not yet recruiting)
    • Sergio Bracarda, MD
    • Sergio Bracarda (Principal Investigator)
  • Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia, Udine, Italy (Not yet recruiting)
    • Marianna Macerelli, MD
    • Marianna Macerelli (Principal Investigator)
  • AOU Integrata di Verona, Verona, Italy (Not yet recruiting)