Your session is about to expire
← Back to Search
PD-1 Inhibitor
Tazemetostat + Topotecan + Pembrolizumab for Small Cell Lung Cancer
Phase 1
Recruiting
Led By Anish Thomas
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 70%)
Patients should be class 2B or better on the New York Heart Association Functional Classification.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat small cell lung cancer that has come back after a period of treatment. The drugs work in different ways to stop the growth of tumor cells. The combination of these drugs may shrink or stabilize the cancer.
Who is the study for?
Adults with recurrent small cell lung cancer who've had platinum-based chemotherapy can join. They must have measurable disease, stable brain metastases if present, and adequate organ function. HIV-positive patients on effective therapy are eligible. Participants need to use contraception and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing the combination of Tazemetostat (an enzyme inhibitor), Topotecan (chemotherapy), and Pembrolizumab (immunotherapy) to see if it's safe and effective for treating recurrent small cell lung cancer by targeting tumor growth in various ways.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation, such as inflammation in organs, infusion-related reactions, fatigue, digestive issues like nausea or diarrhea, blood disorders that could affect clotting or immunity levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly self-sufficient and can carry out daily activities.
Select...
My heart condition allows me to perform daily activities with slight limitations.
Select...
I am 18 years old or older.
Select...
My hepatitis B virus load is undetectable with treatment.
Select...
I had hepatitis C but am cured, or I'm being treated with an undetectable viral load.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (expansion cohort)
Maximum tolerated dose (dose-escalation cohort)
Secondary outcome measures
Duration of response
Overall response rate
Overall survival
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tazemetostat, pembrolizumab, topotecan)Experimental Treatment6 Interventions
Patients receive tazemetostat PO BID on days 1-21, pembrolizumab IV over 30 minutes on day 1, and topotecan IV over 30 minutes on days 1-5. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan throughout the study and may also undergo biopsy and collection of blood on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topotecan Hydrochloride
2013
Completed Phase 3
~6120
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,794 Total Patients Enrolled
Anish ThomasPrincipal InvestigatorNational Cancer Institute LAO
1 Previous Clinical Trials
81 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is within the safe range for the trial.Your hemoglobin level is higher than 9 g/dL or 5.6 mmol/L.Your AST and ALT liver enzymes are not more than 2.5 times the normal level.My tests show genetic changes linked to MDS or MPN.I have had T-cell lymphoblastic lymphoma or T-cell acute leukemia in the past.I have small cell lung cancer that has returned, with measurable disease and prior platinum-based treatment.I haven't had certain cancer treatments in the last 2 to 6 weeks.Pregnant women are not allowed to participate in this study because the study drugs may cause harm to the baby. Breastfeeding should also be stopped if the mother is taking these drugs and for 1 week after the last dose of one of the drugs.I have not received a live vaccine within the last 30 days.I do not have any severe ongoing illnesses that could interfere with the study.I agree to use birth control during and up to 6 months after the study.I have treated brain metastasis and have been stable without steroids for over a week.My blood clotting time is normal or near normal, even if I'm on blood thinners.You had allergic reactions to drugs similar to pembrolizumab and tazemetostat.I have had pneumonitis treated with steroids or have it now.You currently have active hepatitis B or hepatitis C.Your absolute neutrophil count must be equal to or greater than 1,500/mcL.I have recovered from side effects of previous cancer treatments.I haven't taken steroids or immunosuppressants in the last week.I am mostly self-sufficient and can carry out daily activities.My blood clotting time is normal or managed if I'm on blood thinners.I have severe blood cell count issues or a history of certain blood cancers.My heart condition allows me to perform daily activities with slight limitations.I am 18 years old or older.I am HIV positive, on effective treatment, with an undetectable viral load and a CD4 count over 250.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.My brain metastases are stable without steroids for at least 7 days.Your bilirubin levels must be within the normal range set by the hospital, or if they are higher, your direct bilirubin levels must still be within the normal range.Your platelet count needs to be at least 100,000 per microliter.Your white blood cell count is higher than 3000 cells per microliter.My hepatitis B virus load is undetectable with treatment.I had hepatitis C but am cured, or I'm being treated with an undetectable viral load.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tazemetostat, pembrolizumab, topotecan)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the preeminent goals of this medical experiment?
"This medical trial aspires to identify the Maximum Tolerable Dose (MTD) within two years. Secondary objectives include a comprehensive assessment of Overall Response Rate (ORR), Progression-Free Survival (PFS), and Duration of Response (DOR). All will be estimated using Kaplan-Meier methodology with 95% confidence intervals presented in results."
Answered by AI
What is the limit on participants in this clinical experiment?
"Affirmative. Clinicaltrials.gov shows that this investigation, which was initially posted on May 12th 2022, is currently accepting participants. At present, the trial needs to recruit 60 individuals from 8 different healthcare facilities."
Answered by AI
How many locations have been approved to undertake this trial?
"At this time, 8 different medical centres are actively enrolling patients to participate in the study. Of these sites, three of them can be found in Bronx, Lexington and Los Angeles with 5 other locations available for patient selection. It is wise for participants to select a clinic close-by so that travelling demands are minimalised."
Answered by AI
Is it possible to register for this clinical experiment at the moment?
"Affirmative, the clinical trial is still open for enrolment. It was initially posted on May 12th 2022 and recently updated on November 17th of that same year. This study seeks to recruit 60 candidates across 8 medical facilities."
Answered by AI
What evidence exists regarding the safety of utilizing Pembrolizumab?
"Taking all available evidence into account, our team decided to give pembrolizumab a score of 1 as this is an early-phase trial with limited data regarding safety and efficacy."
Answered by AI
Who else is applying?
What site did they apply to?
Northwestern University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I'm the patients partner and he'd like to live longer. We just reunited after 30 years apart. We'd like to spend a few yrs together instead of only a few months.
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger