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Trial record 1 of 1 for:    NCT05091567
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05091567
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : May 30, 2023
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Small-Cell Lung Cancer Drug: Atezolizumab Drug: Lurbinectedin Drug: Carboplatin Drug: Etoposide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 18, 2021
Estimated Primary Completion Date : April 18, 2025
Estimated Study Completion Date : March 6, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Name: 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 Name: 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.


Outcome Measures
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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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

  • Presence or history of 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:

  • Presence or history of 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05091567


Contacts
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Contact: Reference Study ID Number: GO43104 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Jazz Pharmaceuticals
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05091567    
Other Study ID Numbers: GO43104
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: May 30, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
 Etoposide
Atezolizumab
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immune Checkpoint Inhibitors
Antineoplastic Agents, Immunological