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History of Changes for Study: NCT05091567
A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer (IMforte)
Latest version (submitted September 16, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 12, 2021 None (earliest Version on record)
2 October 25, 2021 Study Status and Study Identification
3 December 7, 2021 Recruitment Status, Study Status and Contacts/Locations
4 December 17, 2021 Study Status
5 January 13, 2022 Study Status and Contacts/Locations
6 February 9, 2022 Study Status and Contacts/Locations
7 March 1, 2022 Study Status and Contacts/Locations
8 March 28, 2022 Study Status and Contacts/Locations
9 April 18, 2022 Study Status and Contacts/Locations
10 May 17, 2022 Study Status and Contacts/Locations
11 June 13, 2022 Contacts/Locations and Study Status
12 July 6, 2022 Study Status and Contacts/Locations
13 July 29, 2022 Study Status and Contacts/Locations
14 August 25, 2022 Contacts/Locations and Study Status
15 September 16, 2022 Contacts/Locations and Study Status
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Changes (Merged) for Study: NCT05091567
January 13, 2022 (v5) -- July 6, 2022 (v12)

Changes in: Study Status and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: GO43104
Brief Title: A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer (IMforte)
Official Title: A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab as Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy With Carboplatin, Etoposide and Atezolizumab
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2022 July 2022
Overall Status: Recruiting
Study Start: November 18, 2021
Primary Completion: March 6 April 18, 2026 2025 [Anticipated]
Study Completion: March 6, 2026 [Anticipated]
First Submitted: October 12, 2021
First Submitted that
Met QC Criteria:
October 12, 2021
First Posted: October 25, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
January 13, 2022 July 6, 2022
Last Update Posted: January 18 July 7, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party: Sponsor
Collaborators: Jazz Pharmaceuticals
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.
Detailed Description:
Open or close this module Conditions
Conditions: Small-Cell Lung Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 690 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm A: Atezolizumab+Lurbinectedin

Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles.

Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle.

Drug: Atezolizumab
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.
Other Names:
  • Tecentriq, RO5541267
Drug: Lurbinectedin
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.
Other Names:
  • PM01183/JZP712
Drug: Carboplatin
Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Drug: Etoposide
Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Active Comparator: Arm B: Atezolizumab

Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles.

Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle.

Drug: Atezolizumab
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.
Other Names:
  • Tecentriq, RO5541267
Drug: Carboplatin
Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Drug: Etoposide
Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. IRF-Assessed Progression-Free Survival (PFS)
[ Time Frame: Randomization to the first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 52 months) ]

IRF-assessed progression-free survival (PFS) is defined as the time from randomization to the first occurrence of disease progression as determined by the IRF according to RECIST v1.1, or death from any cause (whichever occurs first).
2. Overall Survival (OS)
[ Time Frame: Randomization to death from any cause (up to approximately 52 months) ]

Overall survival (OS) is defined as the time from randomization to death from any cause.
Secondary Outcome Measures:
1. Investigator-Assessed PFS
[ Time Frame: Randomization to the first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 52 months) ]

Investigator-assessed PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).
2. Confirmed Objective Response Rate (ORR)
[ Time Frame: Up to approximately 52 months ]

Confirmed objective response rate (ORR) is defined as the proportion of randomized participants with a CR or PR on two consecutive occasions >= 4 weeks apart after randomization, as determined by the IRF and the investigator according to RECIST v1.1.
3. Duration of Response (DOR)
[ Time Frame: Up to approximately 52 months ]

Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response after randomization until disease progression as determined by the IRF and the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).
4. PFS Rates
[ Time Frame: 6 months and 12 months after randomization ]

PFS rates at 6 months and 12 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months and 12 months after randomization, as determined by the IRF and the investigator according to RECIST v1.1.
5. OS Rates
[ Time Frame: 12 months and 24 months after randomization ]

OS rates at 12 months and 24 months is defined as the proportion of participants who have not experienced death from any cause at 12 months and 24 months after randomization.
6. Percentage of Participants With Adverse Events
[ Time Frame: Up to approximately 52 months ]

Percentage of participants with adverse events.
7. Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
[ Time Frame: Up to approximately 52 months ]

Percentage of participants with ADAs to atezolizumab after drug administration.
8. Time to Confirmed Deterioration (TTCD)
[ Time Frame: Maintenance phase baseline ]

Time to confirmed deterioration (TTCD) from maintenance baseline in participant-reported physical functioning and global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria for the Induction Phase:

  • ECOG PS of 0 or 1
  • No prior systemic therapy for ES-SCLC
  • Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
  • Histologically or cytologically confirmed ES-SCLC
  • Adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab
  • Measurable disease, as defined by RECIST v1.1
  • Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening

Exclusion Criteria for the Induction Phase:

  • CNS metastases
  • Active or history of autoimmune disease or deficiency
  • History of malignancies other than SCLC within 5 years prior to enrollment
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Treatment with investigational therapy within 28 days prior to enrollment

Inclusion Criteria for the Maintenance Phase:

  • ECOG PS of 0 or 1
  • Ongoing response or stable disease per RECIST 1.1 after 4 cycles of induction therapy
  • Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade <=1
  • Adequate hematologic and end-organ function

Exclusion Criteria for the Maintenance Phase:

  • CNS metastases
  • Receiving consolidative chest radiation
  • Severe infection within 2 weeks prior to randomization into the maintenance
  • Treatment with therapeutic oral or IV antibiotics at the time of randomization
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: GO43104 https://forpatients.roche.com/
Telephone: 888-662-6728 (U.S. and Canada)
Email: global-roche-genentech-trials@gene.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations: United States, Alabama
Alabama Oncology
[Recruiting]
Birmingham, Alabama, United States, 35205
United States, Georgia
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
[Recruiting]
Marietta, Georgia, United States, 30060
United States, Illinois
Illinois Cancer Care
[ Recruiting Active, not recruiting]
Peoria, Illinois, United States, 61615
United States, Louisiana
Hematology Oncology Clinic
[Recruiting]
Baton Rouge, Louisiana, United States, 70809
United States, Maine
New England Cancer Specialists
[Recruiting]
Scarborough, Maine, United States, 04074
United States, Massachusetts
Dana Farber Cancer Institute
[Recruiting]
Boston, Massachusetts, United States, 02215
United States, Michigan
Cancer & Hematology Centers of Western Michigan; Spectrum Health Butterworth Research Pharmacy
[Recruiting]
Grand Rapids, Michigan, United States, 49503
United States, Nevada
Optum Health Care
[Recruiting]
Las Vegas, Nevada, United States, 89102
United States, New York
Clinical Research Alliance
[Recruiting]
Westbury, New York, United States, 11590
United States, Ohio
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
[Recruiting]
Columbus, Ohio, United States, 43219
United States, Tennessee
Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street
[Recruiting]
Chattanooga, Tennessee, United States, 37404
West Clinic
[Recruiting]
Germantown, Tennessee, United States, 38138
Tennessee Oncology; Sarah Cannon Research Institute
[Recruiting]
Nashville, Tennessee, United States, 37203
United States, Texas
Michael E. DeBakey VA Medical Center
[Recruiting]
Houston, Texas, United States, 77030
Belgium
Institut Jules Bordet
[Recruiting]
Anderlecht, Belgium, 1070
UZ Leuven Gasthuisberg
[Recruiting]
Leuven, Belgium, 3000
CHU UCL Mont-Godinne
[Recruiting]
Mont-godinne, Belgium, 5530
Germany
Klinikum Chemnitz gGmbH
[Recruiting]
Chemnitz, Germany, 09116
Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH
[Recruiting]
Essen, Germany, 45136
LungenClinic Großhansdorf GmbH
[Recruiting]
Großhansdorf, Germany, 22927
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
[Recruiting]
Halle, Germany, 06120
Fachklinik für Lungenerkrankungen
[Recruiting]
Immenhausen, Germany, 34376
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
[Recruiting]
Lübeck, Germany, 23538
Asklepios Klinik München-Gauting
[Recruiting]
München-Gauting, Germany, 82131
Greece
Diavalkaniko Hospital
[Recruiting]
Thessaloniki, Greece, 570 01
Italy, Emilia-Romagna
AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
[Recruiting]
Ravenna, Emilia-Romagna, Italy, 48121
Italy, Lombardia
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
[Recruiting]
Milano, Lombardia, Italy, 20141
Korea, Republic of
Chungbuk National University Hospital
[Recruiting]
Cheongju-si, Korea, Republic of, 28644
Samsung Changwon Hospital
[Recruiting]
Gyeongsangnam-do, Korea, Republic of, 51353
Seoul National University Bundang Hospital
[Recruiting]
Seongnam-si, Korea, Republic of, 13605
Samsung Medical Center
[Recruiting]
Seoul, Korea, Republic of, 06351
Ulsan University Hosiptal
[Recruiting]
Ulsan, Korea, Republic of, 44033
Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
[Recruiting]
Guadalajara, Mexico, 44280
Mexico, Mexico CITY (federal District)
Health Pharma Professional Research
[Recruiting]
Cdmx, Mexico CITY (federal District), Mexico, 03100
Mexico, Nuevo LEON
Christus Muguerza Clinica Vidriera
[Recruiting]
Monterrey, Nuevo LEON, Mexico, 64570
Mexico, Oaxaca
Centro de Investigacion Clinica de Oaxaca
[Recruiting]
Oaxaca de Juárez, Oaxaca, Mexico, 68020
Poland
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
[Recruiting]
Gdańsk, Poland, 80-214
Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddział Onkologiczny
[Recruiting]
Kraków, Poland, 31-202
Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
[Recruiting]
Olsztyn, Poland, 10-357
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Oddzial III Chorob Pluc
[Recruiting]
Otwock, Poland, 05-400
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu; Oddzial Onkologii Klinicznej
[Recruiting]
Poznan, Poland, 60-569
Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie; Klinika Nowotworow Pluca i Klatki Piersiowej
[Recruiting]
Warszawa, Poland, 02-781
Spain
Hospital del Mar; Servicio de Oncologia
[Recruiting]
Barcelona, Spain, 08003
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
[Recruiting]
Barcelona, Spain, 08041
Hospital Universitario 12 de Octubre; Servicio de Oncologia
[Recruiting]
Madrid, Spain, 28041
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
[Recruiting]
Sevilla, Spain, 41013
Spain, LA Coruña
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
[Recruiting]
A Coruña, LA Coruña, Spain, 15006
Taiwan
E-DA Hospital; Chest
[Recruiting]
Kaohsiung, Taiwan, 824
Taichung Veterans General Hospital; Dept of Internal Medicine
[Recruiting]
Taichung, Taiwan, 407
National Cheng Kung University Hospital; Oncology
[Recruiting]
Tainan, Taiwan, 00704
Taiwan
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
[Recruiting]
Taipei, Taiwan, 112
Turkey
Adana Baskent University Hospital; Medical Oncology
[Recruiting]
Adana, Turkey, 01120
Gülhane Eğitim Ve Araştırma Hastanesi
[Recruiting]
Ankara, Turkey, 06010
Ankara City Hospital; Oncology
[Recruiting]
Ankara, Turkey, 06800
Uludag Uni Hospital; Oncology
[Recruiting]
Bursa, Turkey, 16059
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
[Recruiting]
Edirne, Turkey, 22030
Bağcılar Medipol Mega Üniversite Hastanesi; Oncology
[Recruiting]
Istanbul, Turkey, 34214
Kocaeli University Faculty of Medicine; Medical oncology
[Recruiting]
Izmit, Turkey, 31380
TC Necmettin Erbakan University Meram Medical Faculty Hospital
[Recruiting]
Konya, Turkey, 42080
Acıbadem Altunizade Hastanesi; Oncology
[Recruiting]
Üsküdar, Turkey, 34662
United Kingdom
Blackpool Victoria Hospital
[Recruiting]
Blackpool, United Kingdom, FY3 8NR
Christie NHS Foundation Trust
[Recruiting]
GB Manchester, United Kingdom, M20 4BX
Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
[Recruiting]
Hull, United Kingdom, HU16 5JQ
Leicester Royal Infirmary
[Recruiting]
Leicester, United Kingdom, LE1 5WW
University College London Hospital
[Recruiting]
London, United Kingdom, NW1 - 2PG
Guy's Hospital; Oncology & Haematology Clinical Trials (OHCT) Unit. GI/Urology Research Office
[Recruiting]
London, United Kingdom, SE1 9RT
Open or close this module IPDSharing
Plan to Share IPD: Yes
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical 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).
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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