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New England Cancer Specialists | Scarborough, ME

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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)

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Roche

Status and phase

Active, not recruiting
Phase 3

Conditions

Small-Cell Lung Cancer

Treatments

Drug: Atezolizumab
Drug: Lurbinectedin
Drug: Carboplatin
Drug: Etoposide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05091567
GO43104

Details and patient eligibility

About

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.

Enrollment

690 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

690 participants in 2 patient groups

Arm A: Atezolizumab+Lurbinectedin
Experimental group
Description:
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.
Treatment:
Drug: Etoposide
Drug: Carboplatin
Drug: Lurbinectedin
Drug: Atezolizumab
Arm B: Atezolizumab
Active Comparator group
Description:
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.
Treatment:
Drug: Etoposide
Drug: Carboplatin
Drug: Atezolizumab

Trial contacts and locations

109

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Central trial contact

Reference Study ID Number: GO43104 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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