Extensive-stage Small-cell Lung CancerPhase 1NCT06807632
A Study of Valemetostat in Combination With Atezolizumab in People With Lung Cancer
A Phase 1 study testing Valemetostat and Atezolizumab in people with Extensive-stage Small-cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- What is being tested?
- Valemetostat and Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- 29 Jan 2025to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- o Adequate bone marrow function as defined by:
- 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
- o Adequate hepatic function as defined by:
- 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
Who cannot join
- 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.
- Prior exposure to valemetostat or other inhibitors of enhancer of zeste homologue-2 (EZH2)
- 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.
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- 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.
- o NOTE: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade >2 for at least 3 months prior to enrollment and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of the following:
- 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).
- o NOTE: Procedures such as a percutaneous biopsy, pleural catheter insertion, placement of a central venous catheter or other minor procedures are permitted.
- 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.
- o Infections controlled on concurrent anti-microbial agents and anti-microbial prophylaxis per institutional guidelines are acceptable.
- Congenital or acquired immunodeficiency, including patients with known history or infection with human immunodeficiency virus (HIV).
- o NOTE: HIV-positive patients who are taking anti-retroviral therapy are still ineligible due to potential PK interactions with valemetostat.
- 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.
- o Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study.
- 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.
- o The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mark Awad, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Jessica Ross, MD, 646-608-4422
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Jessica Ross, MD, 646-608-4422
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Jessica Ross, MD, 646-608-4422
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Jessica Ross, MD, 646-608-4422
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Jessica Ross, MD, 646-608-4422
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Jessica Ross, MD, 646-608-4422
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Jessica Ross, MD, 646-608-4422
About this study
Official title: Phase I Study of Valemetostat and Atezolizumab as Maintenance Therapy for Patients With Extensive-Stage Small Cell Lung Cancer
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
- Extensive-stage Small-cell Lung Cancer
- Being tested
- Valemetostat, Atezolizumab
- Keywords
- Valemetostat, Atezolizumab, Maintenance therapy, 24-290
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValemetostatDrug
Dose level -1 100 mg po once daily
Dose level 1 150 mg po once daily
Dose level 2 200 mg po once daily
AtezolizumabDrug
1680 mg IV q4weeks
| Study group | Role | What they receive |
|---|---|---|
| Valemetostat in Combination With Atezolizumab | Experimental | This is a single institution phase 1 study to assess the safety of valemetostat when used in combination with atezolizumab for the treatment of extensive-stage SCLC patients. We will begin enrollment at a valemetostat dose of 150 mg once daily (dose level 1), with atezolizumab given per standard of care 1680 mg intravenously every four weeks. The study will have two phases, a dose finding phase and an expansion phase. Receives: Drug: Valemetostat; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Progression-free survival (PFS)
The Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria will be used to determine progression-free survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start29 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single institution phase 1 study to assess the safety of valemetostat when used in combination with atezolizumab for the treatment of extensive-stage SCLC patients.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
- Investigators
- Jessica Ross, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807632
- Sponsor's protocol ID
- 24-290
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Valemetostat and Atezolizumab as Maintenance Therapy for Patients With Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06807632
- Acronym / sponsor ID
- 24-290
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Keywords
- Valemetostat, Atezolizumab, Maintenance therapy, 24-290
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Daiichi Sankyo
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single institution phase 1 study to assess the safety of valemetostat when used in combination with atezolizumab for the treatment of extensive-stage SCLC patients.
| Arm | Type | Receives |
|---|---|---|
| Valemetostat in Combination With Atezolizumab | Experimental | Drug: Valemetostat, Drug: AtezolizumabThis is a single institution phase 1 study to assess the safety of valemetostat when used in combination with atezolizumab for the treatment of extensive-stage SCLC patients. We will begin enrollment at a valemetostat dose of 150 mg once daily (dose level 1), with atezolizumab given per standard of care 1680 mg intravenously every four weeks. The study will have two phases, a dose finding phase and an expansion phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (37 listed)
- 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.
- Prior exposure to valemetostat or other inhibitors of enhancer of zeste homologue-2 (EZH2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValemetostatDose level -1 100 mg po once daily Dose level 1 150 mg po once daily Dose level 2 200 mg po once daily | Drug | Valemetostat in Combination With Atezolizumab |
| Atezolizumab1680 mg IV q4weeks | Drug | Valemetostat in Combination With Atezolizumab |
Primary outcome
Determine Phase II dose (RP2D)
Time frame: 1 year
The Common Terminology Criteria for Adverse Events (CTCAE) 5.0 will be used to determine all adverse events and dose-limiting toxicities.
1 secondary outcome
Progression-free survival (PFS)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Awad, MD contact
Jessica Ross, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Valemetostat and Atezolizumab in people with Extensive-stage Small-cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Ross, MD (646-608-4422, stuartj1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Phase II dose (RP2D) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.