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Pembrolizumab + Olaparib for Squamous Cell Carcinoma of the Lung

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have not received prior systemic treatment for their advanced/metastatic NSCLC

Have not received prior systemic treatment for their advanced/metastatic NSCLC.

Must not have

Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

Pivotal Trial

Summary

This trial will compare two treatments for people with squamous non-small cell lung cancer. One treatment will be pembrolizumab plus maintenance olaparib, and the other will be pembrolizumab plus maintenance olaparib placebo. The study's two primary hypotheses are that pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival and overall survival.

Who is the study for?

This trial is for adults with Stage IV squamous non-small cell lung cancer (NSCLC) who haven't had previous systemic treatment. Participants must have a good performance status, meaning they're relatively active and can care for themselves. They need to provide a tumor tissue sample, have no other progressing cancers or severe health conditions like autoimmune diseases or infections such as HIV, and agree to use contraception.

What is being tested?

The study tests if adding olaparib after initial treatment with pembrolizumab improves progression-free survival (time without cancer worsening) and overall survival compared to using pembrolizumab with a placebo. Patients are randomly assigned to one of these two options.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, allergic responses to medication components, blood disorders like anemia from olaparib, fatigue, nausea from chemotherapy drugs used alongside the main treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had any systemic treatment for my advanced lung cancer.

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I haven't had any systemic treatment for my advanced lung cancer.

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My lung cancer is confirmed to be squamous non-small cell type.

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My condition is Stage IV squamous non-small cell lung cancer.

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My condition is Stage IV squamous non-small cell lung cancer.

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I have provided a sample of my tumor tissue that has not been treated with radiation.

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I have given a sample of my tumor for testing, either from an existing sample or a new biopsy.

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My lung cancer is confirmed to be squamous non-small cell type.

Exclusion Criteria

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

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I have been treated with drugs targeting immune checkpoints like PD-L1 or CTLA-4.

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

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I have lung disease or needed steroids for lung inflammation.

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I am allergic to carboplatin, paclitaxel, nab-paclitaxel, or olaparib.

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I have cancer that has spread to my brain or spinal cord.

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

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My lung cancer is not of the squamous type.

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

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I have another cancer that has worsened in the last 3 years and needs treatment.

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I have an immune system disorder or am on long-term steroids.

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I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years 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 (OS)

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Secondary study objectives

Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score

Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score

Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score

+9 more

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + Carboplatin + Taxane + OlaparibExperimental Treatment5 Interventions

For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.

Group II: Pembrolizumab + Carboplatin + Taxane + Olaparib PlaceboActive Control5 Interventions

For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

Pembrolizumab

2017

Completed Phase 3

~2810