A Study of Valemetostat and Atezolizumab for Extensive-Stage Small Cell Lung Cancer
This study is looking for people with newly diagnosed extensive-stage small cell lung cancer (SCLC) to test a combination of two drugs: valemetostat and atezolizumab. Researchers want to find a safe dose of valemetostat that causes few or mild side effects when given with atezolizumab. After finding this dose, they will study it further to see how safe and effective it is. You may be able to join if you are at least 18 years old, have a life expectancy of at least 12 weeks, and a good general health status (ECOG performance status 0 or 1). The main goal is to determine the best dose of valemetostat within one year.
- Study design
- This is an interventional study with a planned enrollment of 24 participants. It will test different doses of valemetostat in combination with atezolizumab.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, determining the Phase II dose, is measured at 1 year.
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NCT06807632
A Study of Valemetostat in Combination With Atezolizumab in People With Lung Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~24 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:ValemetostatAtezolizumab
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine Phase II dose (RP2D)
Measured over 1 year
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Jessica Ross, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 disease, partial or complete response after initial treatment with a platinum doublet regimen in combination with atezolizumab for 4 cycles. It is acceptable to have no measurable disease at the start of this study.
Must be able to begin therapy within 4 weeks of completing the fourth cycle of chemotherapy and immunotherapy.
Adequate hematologic and end-organ function, as defined by the following laboratory test results obtained within 14 days prior to initiation of study treatment. Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to screening laboratory tests:
Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (1500/µL)
Hemoglobin ≥ 9 g/dL
Platelets ≥ 100 x 10\^9/L o Adequate renal function as defined by:
Creatinine clearance ≥ 30 mL/min as calculated using the Cockcroft-Gault equation
AST, ALT, and alkaline phosphatase (ALP) ≤ 3 x ULN with the following exception:
Patients with documented liver metastases: AST, ALT and ALP ≤ 5 x ULN
Exclusion
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.
Refractory nausea and vomiting, malabsorption, biliary shunt, significant bowel resection, or any other condition that significantly affects gut motility or absorption and would preclude adequate absorption of valemetostat in the opinion of the treating physician and/or PI.
Currently receiving radiation therapy, or who have received radiation within 2 weeks prior to the initiation of study treatment, or who plan to receive radiation therapy within the safety evaluation period for dose-limiting toxicity during Cycle 1.
Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline.
Chemotherapy-induced neuropathy
Residual toxicities from prior IO treatment: Grade 1 or Grade 2 endocrinopathies which may include:
Hypothyroidism/ hyperthyroidism
Type I diabetes
Hyperglycemia
Adrenal insufficiency
Adrenalitis
Skin hypopigmentation (vitiligo)
Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).
Uncontrolled or significant cardiovascular disease, including the following:
Evidence of prolongation of QT/QTc interval (e.g., repeated episodes of QT corrected for heart rate using Fridericia's method \[QTcF\] \>470 ms). Electrocardiogram must be registered at rest. For any ECG assessment, if the initial ECG shows a prolonged QTc, then two additional ECGs will be obtained, resulting in three specimens taken after a space of 1 minute, and the mean of the 3 ECGs will be used to determine eligibility and for grading of TRAEs.
Myocardial infarction within 6 months prior to screening o Uncontrolled angina pectoris within 6 months prior to screening o New York Heart Association (NYHA) Class 3 or 4 congestive heart failure
Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg)
Have a known hypersensitivity to any of the components of or known hypersensitivity to either the study drug itself or any of the inactive ingredients in the study drug product.
Known liver cirrhosis.
Uncontrolled active infection requiring IV antibiotic, antiviral, or anti-fungal medications within 14 days prior to initiation of study treatment.
Congenital or acquired immunodeficiency, including patients with known history or infection with human immunodeficiency virus (HIV).
Active tuberculosis
Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test followed by a positive HBV RNA test within 28 days prior to the first dose of study drug. Hepatitis B testing (HBV surface antigen and core antibody) is required only if not done previously.
Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test within 28 days prior to the first dose of study drug. Hepatitis C testing (HCV antibody) is required only if not done previously.
Prior malignancy, active within the previous 3 years, except for locally curable cancer that is currently considered as cured or successfully resected, such as basal or squamous cell carcinoma, superficial bladder cancer, gastric cancer or carcinoma in situ of the prostate, cervix, or breast.
Female patients who have a positive serum pregnancy test during screening or a positive urine pregnancy test on Day 1 before first dose of study drug.
Female patients who are lactating and/or plan to breastfeed during the study treatment or at any point leading up to and including 6 months after the last study drug dose.
What this trial measures
- Determine Phase II dose (RP2D)1 year
The Common Terminology Criteria for Adverse Events (CTCAE) 5.0 will be used to determine all adverse events and dose-limiting toxicities.