Phase I Study of Valemetostat and Atezolizumab as Maintenance Therapy for Patients With Extensive-Stage Small Cell Lung Cancer
Memorial Sloan Kettering Cancer Center
Summary
This study will test whether valemetostat in combination with atezolizumab is a safe treatment that causes few or mild side effects in people with extensive-stage small cell lung cancer (SCLC). The researchers will test different doses of valemetostat to find the highest dose that causes few or mild side effects in participants. After the dose is found, researchers will test it in a new group of participants to learn more about the safety of the study treatment and see if it is an effective treatment for extensive-stage SCLC.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Signed informed consent form (ICF) * Ability to comply with the study protocol as per the investigator's judgment * Age ≥ 18 years at the time of signing the ICF * Life expectancy ≥ 12 weeks * ECOG performance status 0 or 1 * Pathologically confirmed diagnosis of newly diagnosed extensive-stage small cell lung cancer. Patients with a diagnosis of combined small cell lung cancer with other histologies may be considered for inclusion if the predominant histology is SCLC and only after discussion with the study PI. * Radiographically documented RECIST version 1.1 stable dis…
Interventions
- DrugValemetostat
Dose level -1 100 mg po once daily Dose level 1 150 mg po once daily Dose level 2 200 mg po once daily
- DrugAtezolizumab
1680 mg IV q4weeks
Locations (7)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering WestchesterHarrison, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York