Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBindu R Potugari
About this trial
The goal of this clinical trial is to learn if the combination of sacituzumab govetican (SG) and atezolizumab/durvalumab is effective in controlling cancer tumor growth in adults with extensive stage small cell lung cancer. These drugs are FDA approved individually in different cancers. This combination is evaluated in breast cancer and showed promising combination.
The effectiveness of this treatment combination will be measured by changes in tumor size and appearance of new tumors.
Participants in the trial will:
* receive treatment SG and immunotherapy every 21 days for up to 2 years or until it is no longer works for the patient. * CT scans at 6weeks for first 6 cycles and then every 9-12 weeks and MRI brain every 12 weeks. * provide tissue (optional) and blood for additional testing (learn about the cancer).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is willing and able to give informed consent for participation in the trial.
Male or Female aged 18 years or above.
Participants must have a histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) and extensive stage at diagnosis or locally advanced disease and unable to receive curative intent radiation.
Participants must have received at least four cycles of platinum plus etoposide and at least 2-3 cycles of atezolizumab/ Durvalumab.
Disqualifiers
Significant renal impairment requiring dialysis or hepatic impairment with end-stage liver disease.
Participants with leptomeningeal disease.
Participants with a recent diagnosis of heart failure and acute coronary disease within 3 months.
Participants who are unable to receive immunotherapy with chemotherapy for induction will be excluded, or those immunotherapy was discontinued to manage immune-related adverse events
Trial design
Design model
Single group
Treatments tested in this trial
Sacituzumab govitecan
DrugSacituzumab govitecan 10 mg/kg via IV infusion on Day 1 and Day 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment)
Atezolizumab
DrugAtezolizumab 1200mg via IV infusion on Day 1 of a 21-day cycle (ie, once every 3 weeks)
Durvalumab
DrugDurvalumab 1500mg via IV infusion on Day 1 of a 21-day cycle (ie, once every 3 weeks)
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: SG and atezolizumab/durvalumabExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Disease Control
To evaluate the rate of disease control at 12 weeks for patients with extensive stage small cell lung cancer treated with Sacituzumab govitecan (SG) plus atezolizumab or durvalumab as maintenance therapy after induction treatment with chemotherapy and immunotherapy. Disease Control at 12 weeks is defined as a best response by RECIST 1.1 of CR, PR, non-CR, non-PR, or stable disease assessed by RECIST 1.1 and reported within 12 weeks (+/- 2 weeks) from the initiation of study therapy. Participants not known to have disease control at 12 weeks will be coded as lacking disease control.
Time frame
12 weeks from study enrollmentSecondary outcomes
1
Overall Survival
Overall Survival (OS): OS is defined as the duration from study registration to death due to any cause. Patients last known to be alive will be censored at the date of last contact.
Time frame
Through study completion, an average of 1 year2
Progression Free Survival
Progression-free survival (PFS): PFS is defined as the duration from study registration to progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free will be censored at the date of \[last contact or disease assessment\].
Time frame
Through study completion, an average of 1 year3
Combination therapy toxicity
To measure the frequency and severity of toxicity by incidence of treatment-emergent adverse events (TEAEs) and clinical laboratory abnormalities.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov