Actively Recruiting
A Study of Valemetostat in Combination With Atezolizumab in People With Lung Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-01
24
Participants Needed
7
Research Sites
100 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Valemetostat in Combination With Atezolizumab in People With Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Able to follow the study plan as judged by the investigator
- Age 18 years or older at consent
- Life expectancy of at least 12 weeks
- ECOG performance status of 0 or 1
- Confirmed diagnosis of newly diagnosed extensive-stage small cell lung cancer
- Stable disease, partial or complete response after 4 cycles of platinum doublet chemotherapy with atezolizumab
- Able to start study treatment within 4 weeks after finishing 4th cycle of chemotherapy and immunotherapy
- Adequate bone marrow function: ANC ≥ 1.5 x 10^9/L, hemoglobin ≥ 9 g/dL, platelets ≥ 100 x 10^9/L
- Adequate kidney function: creatinine clearance ≥ 30 mL/min
- Adequate liver function: AST, ALT, ALP ≤ 3 times upper limit normal (ULN), or ≤ 5 times ULN if liver metastases present
You will not qualify if you...
- Any uncontrolled systemic diseases or poorly controlled medical conditions
- Receiving chest radiation after initial chemotherapy and immunotherapy
- Symptomatic brain metastases
- Use of moderate or strong CYP3A inducers or certain herbs/fruits affecting valemetostat metabolism within 14 days before treatment
- Previous treatment with valemetostat or other EZH2 inhibitors
- Conditions affecting gut absorption of valemetostat
- Radiation therapy within 2 weeks before study or planned during safety evaluation period
- Unresolved toxicities from prior anticancer treatments above Grade 1 except stable Grade 2 neuropathy or endocrinopathies
- Major surgery or significant injury within 4 weeks before study drug start
- Uncontrolled cardiovascular diseases including prolonged QTc, recent heart attack, uncontrolled angina, severe heart failure, or uncontrolled hypertension
- Known allergy to study drug components
- Liver cirrhosis
- Active infections needing IV antibiotics, antiviral, or antifungal treatment within 14 days prior to treatment
- Immunodeficiency including HIV infection
- Active tuberculosis
- Active hepatitis B or C infection
- Prior malignancy within 3 years except certain cured cancers
- Positive pregnancy test or breastfeeding females
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
C
Charles Rudin, MD, PhD
CONTACT
A
Alissa Cooper, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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