A 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

Phase 1

• Conditions: Small-Cell Lung Cancer; MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-001930-20-DE
• Lead Sponsor: F.Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-22
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 690

Inclusion Criteria

• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• Histologically or cytologically confirmed ES-SCLC (per the VALG staging system)
• No prior systemic treatment for 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
• Submission of pre-induction therapy tumor sample for exploratory biomarker research
• Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening
• Remain abstinent or use contraception and refrain from donating eggs (women) or donating sperm (men)

Inclusion Criteria for the Maintenance Phase
• ECOG performance status (PS) of 0 or 1
• Ongoing response or stable disease per RECIST v1.1 after completion of the induction therapy
• Randomized within 5 weeks (35 days) from last dose of induction therapy, or if receiving PCI, randomized within 9 weeks (63 days) from last dose of induction therapy
• Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade 1 or better
• Adequate hematologic and end-organ function
• For participants not receiving therapeutic anticoagulation: INR and aPTT <= 1.5 x ULN
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 310
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 380

Exclusion Criteria

• Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the final dose of study treatment
• Presence or history of CNS metastases
• Planned consolidative chest radiation
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures
• Active or history of autoimmune disease or deficiency
• Clinically significant liver disease
• 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

Exclusion Criteria for the Maintenance Phase
• Presence or history of CNS metastases
• Receiving consolidative chest radiation
• Lesions that require palliative radiotherapy
• Severe infection within 2 weeks prior to randomization into maintenance phase
• Major surgical procedure, other than for diagnosis, within 4 weeks prior to randomization
• Treatment with therapeutic oral or IV antibiotics at the time of randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified