AzTrials
AzTrials

Extensive Stage Small Cell Lung Cancer (ES-SCLC)Phase 2CARRY-ONNCT06663098

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

A Phase 2 study testing Atezolizumab, Carboplatin and Etoposide in people with Extensive Stage Small Cell Lung Cancer (ES-SCLC), run by Gruppo Oncologico Italiano di Ricerca Clinica at 25 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab, Carboplatin and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
25 sitesItaly
Study dates
24 Jan 2025to 1 Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of small-cell lung cancer (SCLC) (according to WHO classification 2015) confirmed at pathology (histology or cytology).
  • Male or female and ≥ 18 years of age.
  • Life expectancy ≥ 12 weeks.
  • Disease progression at least 60 days after the completion of first-line chemotherapy consisting of at least 4 cycles of platinum-etoposide plus either atezolizumab or durvalumab and have not received any other treatment (except for immunotherapy as maintenance treatment); the 60 day-interval is calculated from the date of the last chemotherapy administration to the date of the first radiologically documented progressive disease.
  • No previous radiotherapy on the only one site disease progression, unless that site had subsequent evidence of progressive disease.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2.
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  • Patients with treated brain metastases (or untreated but asymptomatic) and off steroids or on a stable dose of steroids (≤10 mg of prednisone-equivalent) are also eligible. Radiotherapy must have been completed a minimum of 14 days prior to registration, and patients must have recovered from AEs related to radiotherapy to < grade 1 (except alopecia)
  • For Females: must be postmenopausal (defined as occurring 12 months after last menstrual period) before the screening visit, or are surgically sterile. If they are of childbearing potential, a negative serum pregnancy test prior to study entry has to be documented; furthermore, they agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form (ICF) through 5 months after the last dose of study drug,or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject.
  • For Males: even if surgically sterilized (i.e., post-vasectomy status) agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject.
  • Normal baseline laboratory values as specified below:
  • Absolute neutrophil count (ANC) ≥1500/mm3
  • Platelet count ≥ 100 x 109/L (≥100,000/μL) without transfusion
  • Hemoglobin ≥ 90 g/L (≥ 9 g/dL); patients may be transfused to meet this criterion.
  • Total bilirubin < 1.5x the institutional upper limit of normal (ULN)
  • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5x the institutional ULN (< 5x if liver function test elevations are due to liver metastases)
  • Creatinine < 1.5x institutional ULN or estimated creatinine clearance using the Cockcroft-Gault formula ≥ 30 mL/minute for patients with creatinine levels above institutional limits
  • For patients not receiving therapeutic anticoagulation: INR and aPTT ≤ 1.5 x ULN
  • Negative HIV test at screening {with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200/μL, and have an undetectable viral load}
  • Negative hepatitis B surface antigen (HBsAg) test at screening
  • Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following:
  • Negative total hepatitis B core antibody (HBcAb)
  • Positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA testNegative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening The HCV RNA test must be performed for patients who have a positive HCV antibody test.
  • Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before registration, and otherwise noted in other inclusion/exclusion criteria.
  • Recovered (i.e., ≤ grade 1 toxicity) from effects of prior anticancer therapy, except alopecia.
  • Prior radiotherapy is allowed provided that it has been completed more than 2 weeks before starting protocol treatment and patients have recovered from AEs related to radiotherapy to < grade 1
  • Ability to comply with protocol requirements.
  • The patient or the patient's legal representative has to be able to provide written informed consent. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.

Who cannot join

  • More than 1 line of prior treatment for ES-SCLC.
  • First-line treatment without either atezolizumab or durvalumab.
  • First-line chemotherapy other than platinum-etoposide.
  • Less than 4 cycles of first-line platinum-etoposide.
  • Presence of resistant relapse (progressive disease within 60 days from the end of first-line chemotherapy) or refractory disease (progressive disease during the first 4 cycles of first-line chemoimmunotherapy).
  • Symptomatic brain metastases or spinal cord compression (CT or MRI of the head is required within 4 weeks prior to randomization)requiring immediate radiotherapy for palliation. Patients with treated brain metastases (or untreated but asymptomatic) and off steroids or on a stable dose of steroids (≤10 mg of prednisone-equivalent) are also eligible provided that all of the following criteria are met:
Show all 27Show fewer
  • If treated, at least 14 days between the end of stereotactic radiotherapy or whole brain radiotherapy and initiation of study treatment and recovery from AEs related to radiotherapy to ≤ grade 1 (except alopecia), or at least 28 days between neurosurgical resection and initiation of study treatment;
  • Anticonvulsant therapy at a stable dose is permitted;
  • Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla or spinal cord);
  • There is no evidence of interim intracranial progression between completion of CNS directed therapy (if administered) and initiation of study treatment.
  • Evidence of leptomeningeal disease.
  • Any comorbid condition or unresolved toxicity that would preclude administration of second-line chemotherapy.
  • Patient has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines and COVID vaccines that do not contain live virus are permitted. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment except for PD-L1 inhibitor maintenance as part of first-line treatment.
  • Any condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of registration . The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection);
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent;
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • Diagnosed with or treated for another malignancy within 3 years before the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type may be enrolled in the study if they have undergone complete resection and no evidence of active disease is present.
  • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment other than those in the present study. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
  • Treatment with any other investigational agent within 30 days prior to starting study treatment, or concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  • Infection requiring intravenous antibiotic therapy or other serious infection within 14 days before the first dose of study drug.
  • Prior allogeneic stem cell or solid organ transplantation.
  • For female subjects: positive serum pregnancy test, pregnancy, or breastfeeding.
  • Surgery within 4 weeks (or 2 weeks for a minor surgery) before study enrolment and not fully recovered to baseline or to a stable clinical status. Insertion of a vascular device is allowed.
  • Patients who experienced medically significant or NCI CTCAE Grade 3 or higher toxicities in response to first-line immunotherapy
  • Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Andrea Ardizzoni, MD contact

0039-051-2142206

andrea.ardizzoni@aosp-bo.itt

Giuseppe Lamberti, MD contact

0039-051-2143067

giuseppe.lamberti8@unibo.it

25 sites in 1 country

Italy25 sites, 25 recruiting

  • Centro di Riferimento Oncologico di Aviano (CRO) IRCCS

    Aviano (PN), 33081

    Alessandro Del Conte, MD, 0039-0434-399464, alessandro.delconte@cro.it

    Alessandro Del Conte

    Not yet recruiting

  • IRCCS Istituto Tumori "Giovanni Paolo II"

    Bari, 70124

    Vito Longo, MD, 0039-080555-5478, v.longo@oncologico.bari.it

    Vito Longo

    Not yet recruiting

  • IRCCS Azienda Ospedaliero_Universitaria di Bologna

    Bologna, 40138

    Andrea Ardizzoni, MD, 0039-051-2142206, andrea.ardizzoni@aosp.bo.it

    Recruiting

  • UOC Medicina Oncologica

    Carpi, 41012

    Donatella Giardina, MD, 0039-0596-59294, d.giardina@ausl.mo.it

    Donatella Giardina

    Not yet recruiting

  • ASST Cremona

    Cremona, 26100

    Matteo Brighenti, MD, 0039-0372-408040, MATTEO.BRIGHENTI@ASST-CREMONA.it

    Matteo Brighenti

    Not yet recruiting

  • Azienda Ospedaliera S. Croce e Carle di Cuneo

    Cuneo, 12100

    Ida Colantonio, MD, 0039-0171-616350, colantonio.i@ospedale.cuneo.it

    Ida Colantonio

    Not yet recruiting

  • AOU Careggi

    Florence, 50134

    Francesca Mazzoni, 0039-055-947298, mazzonifr@aou-careggi.toscana.it

    Francesca Mazzoni

    Not yet recruiting

  • Azienda USL Toscana nord-ovest Ospedale Versilia

    Lido di Camaiore, 55041

    Andrea Camerino, MD, 0039-0584-6057282, andrea.camerini@uslnordovest.toscana.it

    Recruiting

  • Azienda USL Toscana Nord Ovest - Ospedale San Luca

    Lucca, 55100

    Editta Baldini, MD, 0039-0583-449545, editta.baldini@usinordovest.toscana.it

    Editta Baldini

    Not yet recruiting

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

    Meldola (FC), 47014

    Angelo Delmonte, MD, 0039-0543-739100, angelo.delmonte@irst.emr.it

    Angelo Delmonte

    Not yet recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Roberto Ferrara, MD, 0039-02-2643-4138, ferrara.roberto@hsr.it

    Roberto Ferrara

    Not yet recruiting

  • AOU Policlinico di Modena

    Modena, 41125

    Federica Bertolini, MD, 0039-059-422-3252, bertolini.federica@aou.mo.it

    Not yet recruiting

  • ASST San Gerardo dei Tintori Foundation

    Monza, 20900

    Diego L Cortinovis, MD, 0039-233-9575, diegoluigi.cortinovis@irccs-sangerardo.it

    Diego Luigi Cortinovis

    Not yet recruiting

  • AORN A. Cardarelli

    Naples, 80131

    Ferdinando Riccardi, MD, 0039-081747-2221, ferdinando.riccardi@aocardarelli.it

    Ferdinando Cardarelli

    Not yet recruiting

  • AOU San Luigi Gonzaga

    Orbassano (TO), 10043

    Enrica Capelletto, MD, 0039-011-9026539, enrica.capelletto@gmail.com

    Not yet recruiting

  • Istituto Oncologico Veneto

    Padova, 35128

    Giulia Pasello, MD, 0039-049-8215608, giulia.pasello@iov.veneto.it

    Giulia Pasello

    Not yet recruiting

  • UOC di Oncologia Medica

    Parma, 43126

    Alessandro Leonetti, MD, 0039-0521-702660, aleonetti@ao.pr.it

    Alessandro Leonetti

    Not yet recruiting

  • Azienda Ospedaliera Santa Maria della Misericordia

    Perugia, 06132

    Giulio Metro, MD, 0039-0755-83695, giulio.metro@ospedale.perugia.it

    Giulio Metro

    Not yet recruiting

  • Azienda USL IRCCS di Reggio Emilia

    Reggio Emilia, 42123

    Maria Pagano, MD, 0039-0522-296602, maria.pagano@ausl.re.it

    Maria Pagano

    Not yet recruiting

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

    Fabiana L Cecere, MD, 0039-0652-666030, fabianaletizia.cecere@ifo.it

    Fabiana Letizia Cecere

    Not yet recruiting

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

    Roma, 00168

    Emilio Bria, MD, 0039-0630-155202, emilio.bria@policlinicogemelli.it

    Emilio Bria

    Not yet recruiting

  • AOU Sassari

    Sassari, 07100

    Antonio Pazzola, MD, 0039-079-2644622, antonio.pazzola@aouss.it

    Antonio Pazzola

    Not yet recruiting

  • Azienda Ospedaliera Santa Maria di Terni

    Terni, 05100

    Sergio Bracarda, MD, 0039-0744-205410, s.bracarda@aospterni.it

    Sergio Bracarda

    Not yet recruiting

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

    Udine, 33100

    Marianna Macerelli, MD, 0039-0432-554586, marianna.macerelli@asufc.sanita.fvg.it

    Marianna Macerelli

    Not yet recruiting

  • AOU Integrata di Verona

    Verona, 37126

    Lorenzo Belluomini, MD, 0039-045-8128127, lorenzo.belluomini@univr.it

    Lorenzo Belluomini

    Not yet recruiting

Other trials in Italy

About this study

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

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:

Read more
  • 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.
Read the detailed description

The CARRY-ON study is a multicenter, prospective, open-label single-arm phase II trial, designed to seek for a signal of efficacy of continuing PD-L1 inhibition in patients with sensitive relapse ES-SCLC by adding atezolizumab to rechallenge carboplatin-etoposide chemotherapy. The trial is planned to enroll 142 patients with sensitive relapse ES-SCLC from 25 Italian centers. Sensitive relapse is defined as SCLC relapsed or progressed to first-line chemo-immunotherapy with PD-L1 inhibition (with either atezolizumab or durvalumab) at least 60 days after the last chemotherapy administration. Eligible patients will receive re-challenge chemotherapy (either carboplatin AUC 4 on day 1 plus etoposide 80 mg/m2 days 1-3 or carboplatin AUC 5 on day 1 plus etoposide 100 mg/m2 days 1-3, at investigator's choice) plus atezolizumab 1200 mg flat dosing on day 1 every 3 weeks until PD, unacceptable toxicity or to a maximum of 4 cycles (induction phase) followed by atezolizumab 1200 mg flat dosing every 3 weeks (maintenance phase) until completion of 1 year of maintenance (up to 18 cycles), progressive disease, unacceptable toxicity, patient refusal or loss of clinical benefit (investigator's choice), whichever occur first.

Subjects will attend clinical visits at regular intervals to receive trial treatment and for efficacy and safety assessments. All subjects will be monitored continuously for any AE while on study treatment.

Radiological assessment will be performed by computed tomography (CT) scan at week 6 (± 7 days), at week 12 (± 7 days) and every 12 weeks (± 7 days) thereafter.

The duration of the study is expected to be a maximum of 45 months. The study recruitment period is expected to be approximately 24 months, maximum treatment duration will be 15 months (3 months of induction and 12 months of maintenance), and subsequent survival follow-up will be a maximum of 6 months.

Keywords
Extensive-stage small cell lung cancer, atezolizumab
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called humanized IgG1 monoclonal antibody against PD-L1

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

  • CarboplatinDrug

    Also called re-challenge chemotherapy

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

  • EtoposideDrug

    Also called re-challenge chemotherapy

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

Study groups in NCT06663098
Study groupRoleWhat they receive
Arm 1Experimentalre-challenge chemotherapy plus atezolizumab 1200 mg flat dosing
Receives: Drug: Atezolizumab; Drug: Carboplatin; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    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.

    Measured: through study completion, an average of 1 year

Secondary outcomes (3)

  1. frequency of adverse events

    Toxicity will be assessed in the mITT population. Descriptive tables will be produced which provide the worst degree of toxicity measured over all cycles according to the NCI-CTCAE version 5.0

    Measured: 30 days post last dose of study drug

  2. Progression Free Survival

    Progression Free Survival (PFS) defined as the time from the patient registration to the evidence of progressive disease, or death, or the last date the patient was known to be progression-free and alive.

    Measured: through study completion, an average of 6 months

  3. Objective response rate

    Objective response rate (ORR) is calculated as the sum of RECIST v1.1-defined CR and PR out of the number of assessable patients with measurable disease at baseline.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start24 Jan 2025
  3. Primary completion30 Aug 2028 (estimated)
  4. Study completion1 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06663098
Sponsor's protocol ID
GOIRC-01-2023
Other IDs
2024-511945-20-00
Acronym
CARRY-ON
Status last verified
Mar 2025
First submitted
21 Oct 2024
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mansfield AS, Kazarnowicz A, Karaseva N, Sanchez A, De Boer R, Andric Z, Reck M, Atagi S, Lee JS, Garassino M, Liu SV, Horn L, Wen X, Quach C, Yu W, Kabbinavar F, Lam S, Morris S, Califano R. Safety and patient-reported outcomes of atezolizumab, carboplatin, and etoposide in extensive-stage small-cell lung cancer (IMpower133): a randomized phase I/III trial. Ann Oncol. 2020 Feb;31(2):310-317. doi: 10.1016/j.annonc.2019.10.021. Epub 2019 Dec 9.

    PubMed 31959349

  • Zitvogel L, Galluzzi L, Smyth MJ, Kroemer G. Mechanism of action of conventional and targeted anticancer therapies: reinstating immunosurveillance. Immunity. 2013 Jul 25;39(1):74-88. doi: 10.1016/j.immuni.2013.06.014.

    PubMed 23890065

  • Li L, Liu T, Liu Q, Mu S, Tao H, Yang X, Li Y, Xiong Q, Wang L, Hu Y. Rechallenge of immunotherapy beyond progression in patients with extensive-stage small-cell lung cancer. Front Pharmacol. 2022 Sep 6;13:967559. doi: 10.3389/fphar.2022.967559. eCollection 2022.

    PubMed 36147357

  • Spagnolo F, Boutros A, Cecchi F, Croce E, Tanda ET, Queirolo P. Treatment beyond progression with anti-PD-1/PD-L1 based regimens in advanced solid tumors: a systematic review. BMC Cancer. 2021 Apr 17;21(1):425. doi: 10.1186/s12885-021-08165-0.

    PubMed 33865350

  • Ardizzoni A, Tiseo M, Boni L. Validation of standard definition of sensitive versus refractory relapsed small cell lung cancer: a pooled analysis of topotecan second-line trials. Eur J Cancer. 2014 Sep;50(13):2211-8. doi: 10.1016/j.ejca.2014.06.002. Epub 2014 Jun 26.

    PubMed 24981975

  • Baize N, Monnet I, Greillier L, Geier M, Lena H, Janicot H, Vergnenegre A, Crequit J, Lamy R, Auliac JB, Letreut J, Le Caer H, Gervais R, Dansin E, Madroszyk A, Renault PA, Le Garff G, Falchero L, Berard H, Schott R, Saulnier P, Chouaid C; Groupe Francais de Pneumo-Cancerologie 01-13 investigators. Carboplatin plus etoposide versus topotecan as second-line treatment for patients with sensitive relapsed small-cell lung cancer: an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2020 Sep;21(9):1224-1233. doi: 10.1016/S1470-2045(20)30461-7.

    PubMed 32888454

  • Frampton JE. Atezolizumab: A Review in Extensive-Stage SCLC. Drugs. 2020 Oct;80(15):1587-1594. doi: 10.1007/s40265-020-01398-6.

    PubMed 32990939

  • Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Shire N, Jiang H, Goldman JW; CASPIAN investigators. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. Epub 2019 Oct 4.

    PubMed 31590988

  • Liu SV, Reck M, Mansfield AS, Mok T, Scherpereel A, Reinmuth N, Garassino MC, De Castro Carpeno J, Califano R, Nishio M, Orlandi F, Alatorre-Alexander J, Leal T, Cheng Y, Lee JS, Lam S, McCleland M, Deng Y, Phan S, Horn L. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021 Feb 20;39(6):619-630. doi: 10.1200/JCO.20.01055. Epub 2021 Jan 13.

    PubMed 33439693

  • Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.

    PubMed 30280641

  • Dingemans AC, Fruh M, Ardizzoni A, Besse B, Faivre-Finn C, Hendriks LE, Lantuejoul S, Peters S, Reguart N, Rudin CM, De Ruysscher D, Van Schil PE, Vansteenkiste J, Reck M; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up☆. Ann Oncol. 2021 Jul;32(7):839-853. doi: 10.1016/j.annonc.2021.03.207. Epub 2021 Apr 20. No abstract available.

    PubMed 33864941

  • Yang S, Zhang Z, Wang Q. Emerging therapies for small cell lung cancer. J Hematol Oncol. 2019 May 2;12(1):47. doi: 10.1186/s13045-019-0736-3.

    PubMed 31046803

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab, Carboplatin and Etoposide in people with Extensive Stage Small Cell Lung Cancer (ES-SCLC), run by Gruppo Oncologico Italiano di Ricerca Clinica at 25 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrea Ardizzoni, MD (0039-051-2142206, andrea.ardizzoni@aosp-bo.itt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06663098, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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