RecruitingPhase 2NCT06663098

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

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

Enrollment

142 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the immunotherapy drug atezolizumab to a second round of platinum-based chemotherapy (the same type used initially) can help people with extensive-stage small cell lung cancer (SCLC) whose cancer has returned after a period of at least 60 days following initial treatment. **You may be eligible if...** - You are 18 or older and have been diagnosed with small cell lung cancer (confirmed by biopsy) - Your cancer progressed or came back at least 60 days after finishing your first round of platinum-etoposide chemotherapy plus immunotherapy (atezolizumab or durvalumab) - You have not received any other cancer treatment between your first-line treatment and now (maintenance immunotherapy is OK) - Your general health allows you to be active and care for yourself (ECOG score 2 or less) - Brain metastases are allowed if they have been treated and are stable **You may NOT be eligible if...** - Your cancer progressed within 60 days of your first-line chemotherapy ending - You have received any additional cancer treatment (other than maintenance immunotherapy) since finishing first-line therapy - You are pregnant or breastfeeding - You have serious immune system disorders or conditions that would make immunotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

1200 mg IV on day 1 of every 21 days, during induction phase and maintenance phase

DRUGCarboplatin

AUC 4 or 5, depending on patient's characteristics, on day 1 every 21 days during induction phase

DRUGEtoposide

80 mg/sqm or 100 mg/sqm, depending on patient's characteristics, on days 1-2-3 of every 21 days


Locations(25)

Centro di Riferimento Oncologico di Aviano (CRO) IRCCS

Aviano (PN), Italy

IRCCS Istituto Tumori "Giovanni Paolo II"

Bari, Italy

IRCCS Azienda Ospedaliero_Universitaria di Bologna

Bologna, Italy

UOC Medicina Oncologica

Carpi, Italy

ASST Cremona

Cremona, Italy

Azienda Ospedaliera S. Croce e Carle di Cuneo

Cuneo, Italy

AOU Careggi

Florence, Italy

Azienda USL Toscana nord-ovest Ospedale Versilia

Lido di Camaiore, Italy

Azienda USL Toscana Nord Ovest - Ospedale San Luca

Lucca, Italy

Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (IRST) "Dino Amadori"

Meldola (FC), Italy

IRCCS Ospedale San Raffaele

Milan, Italy

AOU Policlinico di Modena

Modena, Italy

ASST San Gerardo dei Tintori Foundation

Monza, Italy

AORN A. Cardarelli

Naples, Italy

AOU San Luigi Gonzaga

Orbassano (TO), Italy

Istituto Oncologico Veneto

Padova, Italy

UOC di Oncologia Medica

Parma, Italy

Azienda Ospedaliera Santa Maria della Misericordia

Perugia, Italy

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy

Istituto Nazionale Tumori Regina Elena

Roma, Italy

Fondazione Policlinico Universitario A.Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, Italy

AOU Sassari

Sassari, Italy

Azienda Ospedaliera Santa Maria di Terni

Terni, Italy

Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia

Udine, Italy

AOU Integrata di Verona

Verona, Italy

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NCT06663098


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