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Small Cell Lung CarcinomaPhase 3MAURISNCT04028050

A Study of Atezolizumab in Combination With Carboplatin Plus Etoposide to Investigate Safety and Efficacy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

A Phase 3 study testing Atezolizumab, Carboplatin and Etoposide in people with Small Cell Lung Carcinoma, run by Hoffmann-La Roche at 25 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase IIIB, single-arm, single-country, multicenter study of the safety and efficacy of atezolizumab in combination with carboplatin plus etoposide in patients who have ES-SCLC and are chemotherapy-naive for their extensive-stage disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Carcinoma
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
155 participants
Where
25 sitesItaly
Study dates
12 Aug 2019to 13 Jul 2023
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Histologically or cytologically confirmed ES-SCLC per the Veterans Administration Lung Study Group (VALG) staging system
  • Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) from 0 to 2
  • Life expectancy > 12 weeks
  • No prior systemic treatment for ES-SCLC
  • Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle from diagnosis of ES-SCLC
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  • Patients where thoracic radiotherapy (consolidation RT) is clinically indicated could be enrolled providing they receive RT between the completion of induction phase and the beginning of maintenance phase
  • Patients with Paraneoplastic syndromes can be enrolled if an autoimmune origin can be excluded
  • Adequate hematologic and end organ function
  • Negative human immunodeficiency virus (HIV) test at screening
  • Negative hepatitis B surface antigen (HBsAg) test at screening
  • Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
  • Negative 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 will be performed only for patients who have a positive HCV antibody test.
  • For women of childbearing potential: agreement to remain abstinent or use of contraception
  • For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm

Who cannot join

  • Symptomatic or actively progressing central nervous system (CNS) metastases. Asymptomatic patients with treated or untreated CNS lesions are eligible, provided that all of the following criteria are met: (1) Measurable disease, per RECIST v1.1, must be present outside the CNS. (2) Patient has no history of intracranial hemorrhage or spinal cord hemorrhage. (3) Patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment. (4) Patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted. Metastases are limited to the cerebellum or the supratentorial region. (5) There is no evidence of interim progression between completion of CNS directed therapy and initiation of study treatment. (6) Asymptomatic patients with CNS metastases newly detected at screening are allowed at Investigator's discretion with no need to repeat the screening brain scan.
  • History of leptomeningeal disease
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. Patients with indwelling catheters are allowed regardless of drainage frequency.
  • Uncontrolled or symptomatic hypercalcemia
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
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  • Active tuberculosis
  • Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
  • Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  • History of malignancy other than SCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
  • Prior allogeneic stem cell or solid organ transplantation treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
  • Current treatment with anti-viral therapy for HBV
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Italy25 sites

  • Ospedali Riuniti Di Ancona; Oncology

    Ancona, The Marches, 60121

  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

    Avellino, Campania, 83100

  • Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B

    Aviano, Friuli Venezia Giulia, 33081

  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

    Bologna, Emilia-Romagna, 40138

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy, 25123

  • ASL 3 Genovese

    Genoa, Liguria, 16125

  • Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica

    Lecce, Apulia, 73044

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

    Meldola, Emilia-Romagna, 47014

  • Ospedale San Raffaele S.r.l.

    Milan, Lombardy, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

  • Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

    Milan, Lombardy, 20141

  • Az. Osp. Monaldi; 2 Pneumologia-Chemioterapia E Day Hospital-Pneumoncologia

    Naples, Campania, 80131

  • Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

    Naples, Campania, 80131

  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • A.O.U. Maggiore della Carità

    Novara, Piedmont, 28100

  • Azienda Ospedaliera Vincenzo Cervello

    Palermo, Sicily, 90127

  • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

    Pisa, Tuscany, 56124

  • Ist. Ricovero e Cura a Carattere Scientifico-Centro Rif. Oncologico della Basilica

    Rionero in Vulture (PZ), Basilicate, 85028

  • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

    Rome, Lazio, 00128

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 151

  • Azienda Unita Sanitaria Locale N1 Sassari; Unita Operativa Di Oncologia Medica

    Sassari, Sardinia, 07100

  • Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica

    Taormina, Sicily, 98039

  • ULSS2 Marca Trevigiana; UOC Oncologia Medica - Distretto di Treviso

    Treviso, Veneto, 31100

  • Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia

    Verona, Veneto, 37126

Other trials in Italy

About this study

Official title: A Phase IIIB, Single Arm, Multicenter Study of Atezolizumab (Tecentriq) in Combination With Carboplatin Plus Etoposide to Investigate Safety and Efficacy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer - MAURIS

This is a phase IIIB, single-arm, single-country, multicenter study of the safety and efficacy of atezolizumab in combination with carboplatin plus etoposide in patients who have ES-SCLC and are chemotherapy-naive for their extensive-stage disease.

Read the detailed description

Induction treatment will be administered on a 21-day cycle for four/six cycles. Following the induction phase, participants will continue maintenance therapy with atezolizumab. Maintenance with atezolizumab will continue until disease progression (PD), unacceptable toxicity or loss of clinical benefit.

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 MPDL3280A, RO5541267, Tecentriq

    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After the induction phase, participants will begin maintenance therapy with atezolizumab every 3 weeks.

  • CarboplatinDrug

    Carboplatin will be administered after completion of atezolizumab by IV infusion over 30-60 minutes to achieve an initial target AUC of 5 mg/mL/min (Calvert formula dosing) with standard anti-emetics per local practice guidelines.

  • EtoposideDrug

    Etoposide will be administered by IV infusion over 60 minutes following carboplatin administration, during the induction phase on Day 1 through 3 of each cycle. On Days 2 and 3, patients will receive etoposide alone.

Study groups in NCT04028050
Study groupRoleWhat they receive
Atezolizumab + Carboplatin + EtoposideExperimentalParticipants will receive intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min), followed by intravenous infusion of etoposide 100 milligrams per square meter (mg/m^2) on days 1 through 3 of each cycle during the induction phase (21-day cycle for four/six cycles). On Days 2 and 3, participants will receive etoposide alone. After the induction phase, participants will begin maintenance therapy with atezolizumab every 3 weeks until PD, unacceptable toxicity, loss of clinical benefit or study termination by the Sponsor.
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. Incidence of Serious Adverse Events

    Measured: 4 weeks after last dose of study treatment

  2. Incidence of Serious and Non-Serious Immune Mediated Adverse Events

    Measured: 4 weeks after last dose of study treatment

Secondary outcomes (7)

  1. Overall Survival (OS) Rate at 1 Year

    OS at 1 year, defined as the proportion of participants remaining alive at 1 year after initiation of study treatment.

    Measured: 1 Year

  2. Overall Survival (OS) Rate at 2 Years

    OS at 2 years, defined as the proportion of participants remaining alive at 2 years after initiation of study treatment.

    Measured: 2 Years

  3. Overall Survival (OS) Rate at 3 Years

    OS at 3 years, defined as the proportion of participants remaining alive at 3 years after initiation of study treatment.

    Measured: 3 Years

  4. Overall Survival (OS) Rate

    OS, defined as the time from initiation of study treatment to death from any cause

    Measured: Up to approximately 54 months

  5. Progression-Free Survival (PFS)

    PFS, defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

    Measured: Up to approximately 54 months

  6. Objective response rate (ORR)

    ORR, defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.

    Measured: Up to approximately 54 months

  7. Duration of Response (DOR)

    Duration of response (DOR), defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study. Duration of response will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.

    Measured: Up to approximately 54 months

Timeline

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

  1. First posted22 Jul 2019
  2. Study start12 Aug 2019
  3. Primary completion13 Jul 2023
  4. Study completion13 Jul 2023

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04028050
Sponsor's protocol ID
ML41118
Acronym
MAURIS
Status last verified
Jul 2024
First submitted
19 Jul 2019
Last updated
16 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Publications

  • Bria E, Morgillo F, Garassino MC, Ciardiello F, Ardizzoni A, Stefani A, Verderame F, Morabito A, Chella A, Tonini G, Gilli M, Del Signore E, Berardi R, Mencoboni M, Bearz A, Delmonte A, Migliorino MR, Gridelli C, Pazzola A, Iero M, De Marinis F. Atezolizumab Plus Carboplatin and Etoposide in Patients with Untreated Extensive-Stage Small-Cell Lung Cancer: Interim Results of the MAURIS Phase IIIb Trial. Oncologist. 2024 May 3;29(5):e690-e698. doi: 10.1093/oncolo/oyad342.

    PubMed 38377176

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Carboplatin and Etoposide in people with Small Cell Lung Carcinoma, run by Hoffmann-La Roche 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 15 inclusion and 14 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: finished, as of the sponsor's last update on 16 Jul 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Serious Adverse Events (time frame: 4 weeks after last dose of study treatment). The study lists 2 primary outcomes in all. 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 NCT04028050, which also lists 1 linked publication.

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 16 Jul 2024.

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