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)

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

2023-503868-16-00 (Registry Identifier)

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)

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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