Conditions
Small Cell Lung Cancer, Small Cell Lung Cancer
Trial Purpose
The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.
Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.
Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS.
Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.
NATIONAL TRIAL REFERENCE NUMBER
NCT04624204
EudraCT
2019-003616-31
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Resources
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Age Range
18+
Sex
All
About The Trial
All patients who enrol in the trial will receive medication while on the study.
33% of patients will receive pembrolizumab (pembro) along with chemotherapy* and radiation followed by pembro and olaparib placebo
33% of patients will receive pembro along with chemotherapy* and radiation followed by pembro and olaparib
33% of patients will receive pembro placebo along with chemotherapy* and radiation followed by pembro placebo and olaparib placebo
*Your doctor will decide which chemotherapy treatment (cisplatin with etoposide or carboplatin with etoposide) is best for you.
Trial Phase
Trial Phase 3
Tests the medicine or vaccine in large groups of trial participants (from several hundred to several thousand). For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or doctors’ offices.
Trial start and end dates
- Actual study start date 8 December 2020
- Estimated primary completion date 28 October 2027
- Estimated study completion date 28 October 2027
Trial locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
What can you do next?
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about