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New treatment option for Extensive-stage Small-cell Lung Cancer
Official title A Study of Valemetostat in Combination With Atezolizumab in People With Lung Cancer
ClinicalTrials.gov ID: NCT06807632
What this study is testing
What is Valemetostat?
Valemetostat is an investigational medicine, given as an once-daily, being studied as a potential treatment for extensive-stage small-cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join if
- Any active uncontrolled systemic diseases or other medical conditions considered to be poorly controlled by the investigator including but not...
- 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...
- Receiving concomitant treatment with a moderate or strong inducer of CYP3A within 14 days of first receipt of valemetostat o Consumption of...
- Refractory nausea and vomiting, malabsorption, biliary shunt, significant bowel resection, or any other condition that significantly affects gut...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.