About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Any active uncontrolled systemic diseases or other medical conditions considered to be poorly controlled by the investigator including but not limited to bleeding diatheses, that could in the investigator's opinion, potentially interfere with completion of study procedures or interpretation of study outcomes.
Patients who receive consolidative chest radiation after completion of initial chemotherapy and immunotherapy.
Patients with treated CNS metastases are allowed on the study if their clinical symptoms are adequately controlled and the daily dose of steroid use is equivalent to or less than 10 mg of prednisone. Patients with untreated asymptomatic CNS metastases off of steroids are allowed.
Receiving concomitant treatment with a moderate or strong inducer of CYP3A within 14 days of first receipt of valemetostat o Consumption of herbs/fruits that may have an influence on PK of valemetostat (strong CYP3A inhibitors or inducers) such as St. John's wort, star fruit, Seville orange or Seville orange-containing foods and beverages, grapefruit or grapefruit-containing food or beverages should be avoided from 14 days prior to the start of the study and throughout the entire study.
Trial design
Single group
Treatments tested in this trial
Valemetostat
DrugDose level -1 100 mg po once daily Dose level 1 150 mg po once daily Dose level 2 200 mg po once daily
Atezolizumab
Drug1680 mg IV q4weeks
Treatment groups
Trial outcomes
Primary outcomes
Determine Phase II dose (RP2D)
The Common Terminology Criteria for Adverse Events (CTCAE) 5.0 will be used to determine all adverse events and dose-limiting toxicities.
Secondary outcomes
Progression-free survival (PFS)
The Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria will be used to determine progression-free survival
Sponsors and contacts
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Memorial Sloan Kettering Cancer Center
Lead sponsor
Daiichi Sankyo
Collaborator