Actively Recruiting
Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC).
Led by Gruppo Oncologico Italiano di Ricerca Clinica · Updated on 2025-03-13
142
Participants Needed
25
Research Sites
227 weeks
Total Duration
On this page
Sponsors
G
Gruppo Oncologico Italiano di Ricerca Clinica
Lead Sponsor
R
Roche Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of small-cell lung cancer (SCLC) confirmed by pathology
- Male or female aged 18 years or older
- Life expectancy of at least 12 weeks
- Disease progression at least 60 days after completing first-line platinum-etoposide chemotherapy plus atezolizumab or durvalumab, with no other treatments received
- No prior radiotherapy on the only site of disease progression unless progressive disease is present
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Patients with treated or untreated asymptomatic brain metastases stable on steroids or off steroids
- For females: postmenopausal, surgically sterile, or negative pregnancy test and agreement to use contraception or abstinence
- For males: agreement to use barrier contraception or abstinence during treatment and 6 months afterward
- Normal baseline laboratory values for blood counts, liver and kidney function, and coagulation
- Negative HIV, hepatitis B and C tests or stable controlled infection
- Stable medical condition without recent serious infections or surgeries
- Recovery from prior anticancer therapy side effects to grade 1 or less
- Ability to comply with study protocol and provide informed consent
You will not qualify if you...
- More than one prior treatment line for ES-SCLC
- First-line treatment without atezolizumab or durvalumab
- First-line chemotherapy other than platinum-etoposide
- Less than 4 cycles of first-line platinum-etoposide chemotherapy
- Resistant relapse or refractory disease defined by progression within 60 days of first-line treatment or during first 4 cycles
- Symptomatic brain metastases or spinal cord compression requiring immediate radiotherapy
- Evidence of leptomeningeal disease
- Any condition or toxicity preventing second-line chemotherapy
- Live-virus vaccination within 30 days before treatment start
- Recent treatment with systemic immunostimulatory agents except PD-L1 maintenance
- Systemic corticosteroid or immunosuppressive treatment within 14 days before registration with some exceptions
- Recent or active other malignancies within 3 years except certain skin and in situ cancers
- Concurrent cancer therapies outside this study except non-cancer hormonal therapy
- Use of other investigational agents within 30 days or concurrent enrollment in other interventional studies
- Recent serious infection requiring intravenous antibiotics
- Prior allogeneic stem cell or solid organ transplant
- Positive pregnancy test, pregnancy, or breastfeeding for female subjects
- Recent surgery within 4 weeks (or 2 weeks for minor surgery) without full recovery
- Significant toxicities (grade 3 or higher) from first-line immunotherapy
- Inability or unwillingness to comply with the study protocol or cooperate with study staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Centro di Riferimento Oncologico di Aviano (CRO) IRCCS
Aviano (PN), Italy, 33081
Not Yet Recruiting
2
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, Italy, 70124
Not Yet Recruiting
3
IRCCS Azienda Ospedaliero_Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
4
UOC Medicina Oncologica
Carpi, Italy, 41012
Not Yet Recruiting
5
ASST Cremona
Cremona, Italy, 26100
Not Yet Recruiting
6
Azienda Ospedaliera S. Croce e Carle di Cuneo
Cuneo, Italy, 12100
Not Yet Recruiting
7
AOU Careggi
Florence, Italy, 50134
Not Yet Recruiting
8
Azienda USL Toscana nord-ovest Ospedale Versilia
Lido di Camaiore, Italy, 55041
Actively Recruiting
9
Azienda USL Toscana Nord Ovest - Ospedale San Luca
Lucca, Italy, 55100
Not Yet Recruiting
10
Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (IRST) "Dino Amadori"
Meldola (FC), Italy, 47014
Not Yet Recruiting
11
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Not Yet Recruiting
12
AOU Policlinico di Modena
Modena, Italy, 41125
Not Yet Recruiting
13
ASST San Gerardo dei Tintori Foundation
Monza, Italy, 20900
Not Yet Recruiting
14
AORN A. Cardarelli
Naples, Italy, 80131
Not Yet Recruiting
15
AOU San Luigi Gonzaga
Orbassano (TO), Italy, 10043
Not Yet Recruiting
16
Istituto Oncologico Veneto
Padova, Italy, 35128
Not Yet Recruiting
17
UOC di Oncologia Medica
Parma, Italy, 43126
Not Yet Recruiting
18
Azienda Ospedaliera Santa Maria della Misericordia
Perugia, Italy, 06132
Not Yet Recruiting
19
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Italy, 42123
Not Yet Recruiting
20
Istituto Nazionale Tumori Regina Elena
Roma, Italy, 00144
Not Yet Recruiting
21
Fondazione Policlinico Universitario A.Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, Italy, 00168
Not Yet Recruiting
22
AOU Sassari
Sassari, Italy, 07100
Not Yet Recruiting
23
Azienda Ospedaliera Santa Maria di Terni
Terni, Italy, 05100
Not Yet Recruiting
24
Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia
Udine, Italy, 33100
Not Yet Recruiting
25
AOU Integrata di Verona
Verona, Italy, 37126
Not Yet Recruiting
Research Team
A
Andrea Ardizzoni, MD
CONTACT
G
Giuseppe Lamberti, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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