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Platinum-based Chemotherapy

Pembrolizumab + Chemoradiation +/- Olaparib for Stage III Lung Cancer

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

Has no evidence of metastatic disease indicating Stage IV NSCLC

Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8

Must not have

Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer

Has received prior therapy with an anti-programmed cell death 1 (ant-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 72 months

Awards & highlights

Pivotal Trial

Summary

This trial will compare the efficacy of three different treatments for unresectable, locally advanced NSCLC. Arm 1 will receive pembrolizumab concurrently with chemoradiation, followed by pembrolizumab with olaparib placebo. Arm 2 will receive the same treatment as Arm 1, but will take olaparib instead of the placebo. Arm 3 will receive concurrent chemoradiation therapy followed by durvalumab. The primary hypothesis is that pembrolizumab with concurrent chemoradiation and olaparib is superior to durvalumab with respect to PFS and OS.

Who is the study for?

This trial is for adults with Stage III NSCLC who haven't had previous treatments for this stage, can't have surgery to cure it, and don’t have metastatic (Stage IV) disease. They should be expected to live at least 6 months, able to perform daily activities with little or no help (ECOG 0-1), and must agree to use contraception.

What is being tested?

The study tests pembrolizumab combined with chemoradiation followed by either pembrolizumab plus olaparib placebo or just olaparib versus chemoradiation followed by durvalumab. It aims to see if the first two methods are better than the third in improving survival without cancer progression.

What are the potential side effects?

Possible side effects include immune system reactions affecting organs, infusion-related reactions, fatigue, nausea, blood cell changes increasing infection risk. Specifics depend on each drug combination but may also involve lung issues like pneumonitis.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer has not spread to other parts of my body.

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My lung cancer is at stage IIIA, IIIB, or IIIC.

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I cannot have surgery to cure my Stage III lung cancer.

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My lung cancer diagnosis was confirmed through lab tests.

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My lung cancer diagnosis is confirmed by lab tests.

Exclusion Criteria

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

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I have had radiation therapy to my chest area before.

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I have been treated with specific immune therapy for cancer.

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

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I am currently being treated for active tuberculosis.

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I cannot swallow pills or have a gut condition affecting drug absorption.

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My lung cancer is of the small cell type or has small cell elements.

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I cannot stop taking aspirin or NSAIDs, except for low-dose aspirin, for 2 days before and after treatment.

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I have received an organ or tissue transplant from another person.

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I am taking strong or moderate drugs that affect liver enzymes and can't stop them for the study.

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I have or had lung inflammation that needed steroids.

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I have a history of Hepatitis B or an active Hepatitis C infection.

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

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I have lost more than 10% of my weight in the last 3 months.

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I have not received a live vaccine within the last 30 days.

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

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I cannot or will not take folic acid, vitamin B12, and dexamethasone with pemetrexed.

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I will need cancer treatment other than the study offers while participating.

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I have not had major surgery within the last 4 weeks, except for vascular access placement.

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I am taking medication that strongly or moderately affects my liver enzyme levels and cannot stop during the study.

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I am currently being treated for an infection.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 72 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 72 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 72 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 (OS)

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Secondary study objectives

Change From Baseline in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score

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

Change From Baseline in Dyspnea Using the EORTC QLQ-C30 Item 8 Score

+13 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

Active Control

Group I: pembrolizumab+chemoradiation→pembrolizumab+olaparib placeboExperimental Treatment8 Interventions

Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year.

Group II: pembrolizumab+chemoradiation→pembrolizumab+olaparibExperimental Treatment8 Interventions

Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year.

Group III: chemoradiation→durvalumabActive Control7 Interventions

Participants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Etoposide

2010

Completed Phase 3

~2960

Cisplatin

2013

Completed Phase 3

~3120