← Back to Search

Chemotherapy

Chemoradiation + Pembrolizumab/Olaparib for Small Cell Lung Cancer

Phase 3
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has pathologically confirmed Small Cell Lung Cancer (SCLC) excluding mixed tumors with small cell and non-small cell elements
Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 82 months
Awards & highlights

Study Summary

This trial will compare overall survival and progression free survival of two groups of patients with advanced solid tumors - those who receive concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib, and those who receive concurrent chemoradiation therapy alone.

Who is the study for?
This trial is for adults with newly diagnosed, treatment-naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) who have a good performance status and can be treated with radiation. They must not have received any prior treatments for LS-SCLC or have any history of certain diseases like HIV, Hepatitis B/C, or autoimmune disease requiring recent treatment. Participants should not be pregnant, must agree to use contraception, and cannot have participated in another investigational study recently.Check my eligibility
What is being tested?
The trial tests if adding pembrolizumab (an immunotherapy drug) and olaparib (a PARP inhibitor) to standard chemoradiation therapy improves survival without cancer progression compared to chemoradiation alone. Patients are randomly assigned to receive either the new combination of drugs or a placebo alongside their regular cancer treatment.See study design
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs, infusion reactions from the drug entering the body, fatigue, blood disorders that affect how your blood clots or fights infection, digestive issues like nausea or diarrhea, and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with pure Small Cell Lung Cancer.
Select...
I am not pregnant and will follow birth control advice during and after the study.
Select...
I can provide a sample of my tumor before treatment starts.
Select...
I will not breastfeed during and for 4 months after the study if I receive Pembrolizumab, or for 1 week if I receive Olaparib.
Select...
My organs are functioning well.
Select...
I am not expected to need surgery to remove a tumor during the study.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I will not donate sperm during and after the treatment for a specified period.
Select...
I have not had any treatment for my small cell lung cancer.
Select...
My small cell lung cancer is in an early stage and can be treated with radiation.
Select...
I am 18 years old or older.
Select...
My scans show no signs of cancer spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 82 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 82 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival: the time from randomization to death due to any cause
Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first
Secondary outcome measures
Change from Baseline at Cycle 1 in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Change from Baseline at Cycle 1 in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
Change from Baseline at Cycle 1 in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
+15 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BIDExperimental Treatment7 Interventions
Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg Q6W plus olaparib 300 mg BID for 12 months or until specific discontinuation criteria are met.
Group II: Group A - Pembrolizumab 200 mgExperimental Treatment7 Interventions
Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg every 6 weeks (Q6W) plus olaparib matching placebo twice daily (BID) for 12 months or until specific discontinuation criteria are met.
Group III: Group C (Pembrolizumab and Olaparib Matching Placebos)Placebo Group6 Interventions
Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab placebo (saline) Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab placebo (saline) Q6W plus olaparib matching placebo for 12 months or until specific discontinuation criteria are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab 200 mg
2013
Completed Phase 3
~720
Etoposide 100 mg/m^2
2013
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,868 Previous Clinical Trials
5,051,327 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,242 Total Patients Enrolled
Medical Director, MDStudy DirectorMerck Sharp & Dohme LLC
76 Previous Clinical Trials
15,572 Total Patients Enrolled

Media Library

Etoposide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04624204 — Phase 3
Small Cell Lung Cancer Research Study Groups: Group C (Pembrolizumab and Olaparib Matching Placebos), Group A - Pembrolizumab 200 mg, Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID
Small Cell Lung Cancer Clinical Trial 2023: Etoposide Highlights & Side Effects. Trial Name: NCT04624204 — Phase 3
Etoposide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04624204 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the usual reason that doctors recommend Standard Thoracic Radiotherapy?

"Standard Thoracic Radiotherapy, a type of cancer treatment, is most often used to treat malignant melanoma of the skin. However, it can also be used to manage other conditions, such as merkel cell cancer, recurrent cervical cancer, and refractory, relapsed mediastinal large b-cell lymphoma."

Answered by AI

Is it legal to administer Standard Thoracic Radiotherapy?

"There is both historical data and recent data supporting the safety of Standard Thoracic Radiotherapy, so it received a score of 3."

Answered by AI

Is this research project happening in multiple states?

"There are 29 sites participating in this clinical trial. The sites are located in cities including Houston, Montréal, and Trois-Rivieres. If you are considering participating in the trial, it is best to choose a location that is nearest to you to minimize travel demands."

Answered by AI

What other medical studies have been completed that use Standard Thoracic Radiotherapy?

"As of now, there are 1588 distinct clinical trials researching Standard Thoracic Radiotherapy. Of those, 280 are in Phase 3. Most of the research for Standard Thoracic Radiotherapy is centered in Houston, Texas, but there are 71273 locations running trials for this treatment globally."

Answered by AI

Does this research project have any current openings for participants?

"This is accurate. The aforementioned website lists this trial as currently looking for participants. This study was initially posted on December 8th, 2020, and was most recently edited on November 7th, 2022. A total of 672 patients will be enrolled at 29 different hospitals."

Answered by AI
Recent research and studies
~344 spots leftby Oct 2027