A clinical trial to look at how well venetoclax plus atezolizumab, carboplatin and etoposide work to reduce certain signs of extensive-stage small cell lung cancer and how safe venetoclax is at different doses.

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).

  • Cancer
  • Lung Cancer
  • Small Cell Lung Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Terminated

This trial runs in
Cities
  • Atlanta
  • København
  • L'Hospitalet de Llobregat
  • Madrid
  • Seoul
Trial Identifier:

NCT04422210 2019-004487-22 GO41864

      Show trial locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      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.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT04422210,GO41864,2019-004487-22 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      How does the GO41864 clinical trial work?
      This clinical trial is recruiting people who have a type of disease called small cell lung cancer (SCLC). In order to take part, patients must have extensive-stage small cell lung cancer (ES-­SCLC).

      The purpose of this clinical trial is to find the best dose of venetoclax and to test the safety of venetoclax in combination with atezolizumab, carboplatin and etoposide. 

      How do I take part in this clinical trial?
      To be able to take part in this clinical trial, you must have been diagnosed with ES-SCLC. You cannot join the trial if you are pregnant or breastfeeding. 

      If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

      You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

      Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part. 

      While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons. 

      What treatment will I be given if I join this clinical trial? 
      Everyone who joins this clinical trial will be enrolled into one of two parts; these parts are called the Dose-Escalation Phase and the Dose-Expansion Phase.

      Dose-Escalation Phase
      If you are enrolled into this Phase you will then be placed into one of two groups: Group A or Group B. Group A will be tested first. If patients in Group A are able to take the treatment without any serious side effects, Group B will be opened. 

      Group A – venetoclax plus atezolizumab 

      • Patients who have completed 4−6 rounds of chemotherapy with carboplatin and etoposide will be placed in Group A.
        • Venetoclax given as a tablet to take each day for a 3-week cycle 
          • If patients are able to take venetoclax without serious side effects, the dose of venetoclax will be increased for the next set of patients
        • Atezolizumab given as an infusion into the vein every 3 weeks

      OR

      Group B – venetoclax, atezolizumab, carboplatin and etoposide 

      • Patients who have not received any previous treatment for ES-SCLC will be placed in Group B.
        • 4 rounds of treatment with venetoclax, atezolizumab, carboplatin and etoposide
          • Venetoclax is given as a tablet to take each day for 7 days of a 3-week cycle
            • If patients are able to take venetoclax without serious side effects, the dose of venetoclax will be increased for the next set of patients
          • Atezolizumab and carboplatin are given as infusions into the vein every 3 weeks
          • Etoposide is given as an infusion into the vein for the first 3 days 
        • You will then receive venetoclax plus atezolizumab 
          • Venetoclax is given as a tablet to take each day based on the safe dose that was found in Group A
          • Atezolizumab is given as an infusion into the vein every 3 weeks

      Dose-Expansion Phase
      Once the Dose-Escalation Phase has established the most effective and safe dose of venetoclax, more patients will be included in the study in the Dose-Expansion Phase. New patients will be added to Group A or Group B, depending on what the results from the Dose-Escalation Phase showed.

      How often will I be seen in follow-up appointments and for how long?
      You will be given the clinical trial treatment venetoclax, atezolizumab, carboplatin and etoposide OR venetoclax plus atezolizumab for as long as it can help you. During treatment, you will be seen by the clinical trial doctor every 3 weeks to see how you are responding to the treatment and any side effects that you may be having. You are free to stop this treatment at any time. After stopping treatment, you will still be seen in clinic or contacted via telephone regularly by the clinical trial doctor every 3 months.

      What happens if I am unable to take part in this clinical trial?
      If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

      For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04422210?term=NCT04422210&draw=2&rank=1

      Trial Summary

      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.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT04422210,GO41864,2019-004487-22 Trial Identifier
      Venetoclax, Atezolizumab, Carboplatin, Etoposide Treatments
      Small Cell Lung Cancer Condition
      Official Title

      A Phase Ib Dose-Escalation and Dose-Expansion Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Patients With Untreated Extensive-Stage Small Cell Lung Cancer.

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      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.
      Exclusion Criteria
      • 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.
      • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation.
      • History of allergic reactions to carboplatin or etoposide or to any of its excipients (etoposide).
      • Known hypersensitivity to venetoclax or to any of its excipients.
      • Administration of Steroid therapy for anti-neoplastic intent, strong or moderate CYP3A inhibitors or strong or moderate CYP3A inducers within 7 days prior to the first dose of study drug.
      • Consumption of grapefruit, grapefruit products, Seville oranges (including marmalade-containing Seville oranges), or starfruit (carambola) within 3 days prior to the first dose of study drug.
      • Malabsorption syndrome or other condition that would interfere with enteral absorption.
      • Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgement.
      • Inability or unwillingness to swallow a large number of tablets.
      • History of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or active bowel inflammation (e.g., diverticulitis).

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