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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05091567
Recruitment Status : Active, not recruiting
First Posted : October 25, 2021
Last Update Posted : March 12, 2024
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE October 12, 2021
First Posted Date  ICMJE October 25, 2021
Last Update Posted Date March 12, 2024
Actual Study Start Date  ICMJE November 18, 2021
Estimated Primary Completion Date April 18, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2024)
  • IRF-Assessed Progression-Free Survival (PFS) [ Time Frame: Randomization to the date of first documented disease progression or death, whichever occurs first (up to approximately 60 months) ]
    IRF-assessed progression-free survival (PFS) is defined as the time from randomization to the date of first documented disease progression (as assessed by the IRF according to RECIST v1.1), or death whichever occurs first.
  • Overall Survival (OS) [ Time Frame: Randomization to the date of death from any cause (up to approximately 60 months) ]
    Overall survival (OS) is defined as the time from randomization to the date of death from any cause.
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2021)
  • 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).
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2024)
  • Investigator-Assessed PFS [ Time Frame: Randomization to the first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 60 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).
  • Confirmed Objective Response Rate (ORR) as Determined by the IRF [ Time Frame: Up to approximately 60 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 according to RECIST v1.1.
  • Confirmed Objective Response Rate (ORR) as Determined by the Investigator [ Time Frame: Up to approximately 60 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 Investigator according to RECIST v1.1.
  • Duration of Response (DOR) as Determined by the IRF [ Time Frame: Up to approximately 60 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 according to RECIST v1.1, or death from any cause, whichever occurs first.
  • Duration of Response (DOR) as Determined by the Investigator [ Time Frame: Up to approximately 60 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 investigator according to RECIST v1.1, or death from any cause, whichever occurs first.
  • PFS Rates as Determined by the IRF [ 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 according to RECIST v1.1.
  • PFS Rates as Determined by the Investigator [ 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 investigator according to RECIST v1.1.
  • 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.
  • Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 60 months ]
    Percentage of participants with adverse events.
  • Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab [ Time Frame: Up to approximately 60 months ]
    Percentage of participants with ADAs to atezolizumab after drug administration.
  • Time to Confirmed Deterioration (TTCD) [ Time Frame: Up to approximately 60 months ]
    Time to confirmed deterioration (TTCD) from randomization 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2021)
  • 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).
  • 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.
  • 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).
  • 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.
  • 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.
  • Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 52 months ]
    Percentage of participants with adverse events.
  • 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.
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small-Cell Lung Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Atezolizumab
    • Drug: Lurbinectedin
    • Drug: Carboplatin
    • Drug: Etoposide
  • 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.

    Interventions:
    • Drug: Atezolizumab
    • Drug: Carboplatin
    • Drug: Etoposide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 12, 2021)
690
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 6, 2026
Estimated Primary Completion Date April 18, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany,   Greece,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Poland,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05091567
Other Study ID Numbers  ICMJE GO43104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Jazz Pharmaceuticals
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP