A Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Participants With Untreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC).

Stopped early · Phase 1

Conditions studied: Small Cell Lung Cancer

In brief

A study consisting of a dose-escalation phase and a dose-expansion phase to evaluate the safety, tolerability, pharmacokinetics, and efficacy of venetoclax in combination with atezolizumab, carboplatin, and etoposide.

Key facts

Study ID

NCT04422210

Run by

Hoffmann-La Roche

People needed

2

Starts

2020-09-22

Expected to finish

2020-11-06

Last updated by the study team

2021-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Dose Escalation, Maintenance Arm A:
• Participants with ES-SCLC who have completed 4-6 cycles of carboplatin and etoposide induction chemotherapy, with or without atezolizumab, as their first-line therapy for extensive-stage disease and have responded (CR or PR) or have Stable Disease (SD) are eligible for the maintenance arm of the study.
• All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline.
• A maximum of 8 weeks (56 days) is allowed between last chemotherapy dose (Cycle 4, Day 3) given in induction and the start of maintenance therapy.
• Dose Escalation, Induction Arm B:
• Participants with no prior systemic treatment for ES-SCLC are eligible for this study.
• ANC >= 1,500 cells/µL without granulocyte colony-stimulating factor support.
• Dose Expansion, Maintenance-Only:
• Participants with ES-SCLC who have completed 4 cycles of carboplatin and etoposide induction chemotherapy and at least 3 cycles of atezolizumab as their first-line therapy for extensive-stage disease and have responded (CR or PR) or have SD are eligible for the maintenance arm of the study.
• Dose Escalation (Arms A and B) and Dose Expansion:
• Ability to comply with the study protocol, in the investigator's judgement.
• ECOG performance status of 0 or 1.
• Participants must be able to swallow pills.
• Histologically or cytologically confirmed diagnosis of ES-SCLC per the Veterans Administration Lung Study Group (VALG) staging system.
• Participants who received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy or chemoradiotherapy cycle prior to diagnosis of ES-SCLC.
• Participants with a history of treated CNS metastases that are currently asymptomatic.
• Measurable disease, as defined by RECIST v1.1. Baseline measurements and evaluation of all sites of disease must be obtained =<4 weeks prior to enrollment.
• Eligible to receive a carboplatin-based chemotherapy regimen.
• Adequate hematologic and end-organ function.
• Participants must submit a pre-treatment tumor tissue sample.
• Participants must submit a blood sample for exploratory biomarker research before treatment, on-study, and following progression of disease.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use non-hormonal contraceptive methods and refrain from donating eggs.
• Women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug.
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm.

You may not qualify if…

• Use of non-protocol-specified anti-cancer therapies or other combination partners with carboplatin/etoposide during induction.
• Symptomatic or actively progressing CNS metastases.
• Pregnant or breastfeeding, or intending to become pregnant during the study.
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 1 week prior to enrollment.
• Leptomeningeal disease.
• Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (once a month or more frequently).
• Uncontrolled or symptomatic hypercalcemia.
• History of malignancy other than SCLC within 5 years prior to enrollment.
• History of autoimmune disease.
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
• Positive HIV infection.
• Active Hepatitis B and C infection (HBV/HCV).
• Active Tuberculosis infection.
• Known infection with human T-cell leukemia virus 1.
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization.
• Significant cardiovascular disease.
• Major surgical procedure within 28 days prior to enrollment or anticipation of need for major surgical procedure during the course of the study.
• Prior allogenic bone marrow transplantation or solid organ transplant.
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications.
• Illnesses or conditions that interfere with their capacity to understand, follow, and/or comply with study procedures.
• Treatment with investigational therapy with therapeutic intent within 28 days prior to enrollment.
• Administration of a live, attenuated vaccine within 4 weeks before enrollment or anticipation that such a live attenuated vaccine will be required during the study.
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
• Treatment with systemic immunosuppressive medications within 1 week prior to enrollment.
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.

Where it is running

• Emory University — Atlanta, Georgia, United States
• Rigshospitalet; Onkologisk Klinik — København Ø, Denmark
• Severance Hospital, Yonsei University Health System — Seoul, South Korea
• ICO I Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet ICO — L'Hospitalet de Llobregat, Barcelona, Spain
• START Madrid. Centro Integral Oncologico Clara Campal; CIOCC — Madrid, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.