A Study of Valemetostat in Combination With Atezolizumab in People With Lung Cancer

NCT06807632 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 24-290
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Extensive-stage Small-cell Lung Cancer

Keywords

Valemetostat; Atezolizumab; Maintenance therapy; 24-290

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Progression-free survival (PFS)

  1 year

Study Arms (1)

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.

Drug: Valemetostat; Drug: Atezolizumab

Interventions

Valemetostat DRUG

Dose level -1 100 mg po once daily Dose level 1 150 mg po once daily Dose level 2 200 mg po once daily

Valemetostat in Combination With Atezolizumab

Atezolizumab DRUG

1680 mg IV q4weeks

Valemetostat in Combination With Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:

You may not qualify if:

• 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.
• Symptomatic CNS metastases
• 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.
• 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.
• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Daiichi Sankyo: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Charles Rudin, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Rudin, MD, PhD

CONTACT

646-608-3788; rudinc@mskcc.org

Alissa Cooper, MD

CONTACT

646-608-4322

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: January 29, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (7)