RecruitingPhase 1NCT06807632

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

Phase I Study of Valemetostat and Atezolizumab as Maintenance Therapy for Patients With Extensive-Stage Small Cell Lung Cancer


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

24 participants

Start Date

Jan 29, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining valemetostat — a drug that targets a protein that regulates gene activity in cancer cells — with atezolizumab (an immunotherapy drug) after initial chemotherapy can help keep extensive-stage small cell lung cancer from returning or progressing. **You may be eligible if...** - You are 18 or older - You have been diagnosed with extensive-stage small cell lung cancer (cancer that has spread beyond one lung) - Your cancer showed stable disease, partial response, or complete response after 4 cycles of initial chemotherapy (platinum-based) combined with atezolizumab - You are in generally good health (ECOG status 0 or 1) - Your blood counts, liver, and kidney function are adequate - You can start the study treatment within 4 weeks of completing your 4th chemotherapy cycle **You may NOT be eligible if...** - You have a life expectancy of less than 12 weeks - Your cancer progressed during initial chemotherapy - You have significant autoimmune disease, serious active infections, or uncontrolled medical problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGValemetostat

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

DRUGAtezolizumab

1680 mg IV q4weeks


Locations(7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06807632


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