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.

Learn More on ClinicalTrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT04624204

When speaking to your doctor, please have the trial identifier number available.

About The Study

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.

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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 physician offices.

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Dates

  • Actual study start date 8 December 2020
  • Estimated primary completion date 28 October 2027
  • Estimated study completion date 28 October 2027

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

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Conditions

Small Cell Lung Cancer

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Age Range

18 - No Age Maximum

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Sex

All

Trial locations

Locations provided may not reflect the most current site information. Please call the number provided in the location results to confirm.