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Chemotherapy

Chemoradiation + Pembrolizumab/Olaparib for Small Cell Lung Cancer

Phase 3

Waitlist Available

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

Is not expected to require tumor resection during the course of the study

Must not have

Has an active infection requiring systemic therapy

Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 82 months

Awards & highlights

Pivotal Trial

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.

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.

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

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I have been diagnosed with pure Small Cell Lung Cancer.

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I am not expected to need surgery to remove a tumor during the study.

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I have not had any treatment for my small cell lung cancer.

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My small cell lung cancer is in an early stage and can be treated with radiation.

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My scans show no signs of cancer spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for an infection.

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I have a history of HIV, Hepatitis B, or active Hepatitis C.

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I have had lung inflammation that needed steroids.

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I have or might have a blood disorder like MDS or AML.

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I have been treated with olaparib or another PARP inhibitor before.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have been treated for an autoimmune disease in the last 2 years.

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I have been treated with specific immune therapy for cancer.

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I have not had major surgery within the last 4 weeks, except for procedures to place a vascular access.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 82 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~930

Etoposide 100 mg/m^2

2013

Completed Phase 1

~60