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Prostacyclin Analogue

Iloprost for Preventing Lung Cancer in Former Smokers

Phase 2

Waitlist Available

Led By Seema Khan

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Former smokers (> 12 months abstinent and confirmed by serum cotinine) with at least a 30 pack-year cigarette history

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Must not have

Taking any antiplatelet agent

A biopsy on baseline bronchoscopy with a dysplasia score of 7 or 8 (carcinoma in situ or invasive cancer)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Summary

This trial will test whether the drug iloprost can prevent lung cancer in former smokers. Iloprost has been shown to reduce abnormal lung cells in former smokers, so it may help lower the risk of developing cancer.

Who is the study for?

This trial is for former smokers who have been smoke-free for over a year, with a history of heavy smoking (at least 30 pack-years), and either COPD or abnormal lung cells. They must be disease-free lung cancer survivors, at least 50 years old, able to undergo bronchoscopy safely, and meet certain health criteria like adequate blood counts.

What is being tested?

The study tests if oral Iloprost can prevent lung cancer in ex-smokers by reducing abnormal lung cells. Participants will receive either Iloprost or a placebo and undergo various assessments including questionnaires, biopsies during bronchoscopy, and biospecimen collection to evaluate the drug's effectiveness.

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions similar to those seen in other trials involving Iloprost such as headache, flushing, jaw pain or nausea. The procedure-related risks involve bleeding from biopsy sites or discomfort from bronchoscopy.

Eligibility Criteria

Inclusion Criteria

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

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I quit smoking over a year ago after smoking for 30 or more years.

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I am mostly self-sufficient and can carry out daily activities.

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I have chronic obstructive pulmonary disease (COPD).

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I am at least 50 years old.

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I can safely have a bronchoscopy procedure.

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My lung biopsy shows early signs of abnormal cells.

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I had a lung biopsy showing moderate to severe abnormal cells.

Exclusion Criteria

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

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I am currently taking medication to prevent blood clots.

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My biopsy shows early or invasive cancer with a score of 7 or 8.

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I survived stage III NSCLC or any stage SCLC treated with the intent to cure.

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I am currently on hormone or immune therapy, including BCG.

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I am taking blood thinners other than aspirin.

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I have cancer that has spread to other parts of my body.

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I have had radiation therapy on my chest or head/neck, or received immunotherapy.

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I need extra oxygen (4 liters/min) to keep my oxygen levels above 90%.

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I am not pregnant or breastfeeding while receiving iloprost treatment.

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I am not currently on experimental drugs nor have I used iloprost before.

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I have a known bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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

Bronchoscopy

Secondary study objectives

Change in the average WHO score of all biopsy sites with a baseline score of 4 or greater

Incidence of adverse events with oral iloprost

Other study objectives

Change in glass opacity (GGOs) volume

Histologic response by alternative criteria

In vitro response of bronchial epithelial progenitor cells cultured at the air-liquid interface

+3 more

Side effects data

From 2020 Phase 2 trial • 28 Patients • NCT02230189

Pregnancy identified during study enrollment

Increased systolic blood pressure post-bronchoscopy

Respiratory infection post-bronchoscopy

100%

80%

60%

40%

20%

Study treatment Arm

Allergic Asthmatics(AA)

Allergic Non-Asthmatics(ANA)

Non-Allergic Non-Asthmatics(NANA)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (iloprost)Experimental Treatment5 Interventions

Patients receive Iloprost PO BID for a 180 days in the absence of unacceptable toxicity. Patients undergo bronchoscopy with biopsies and brushings at day 180.

Group II: Arm II (placebo)Placebo Group5 Interventions

Patients receive placebo PO BID for a 180 days in the absence of unacceptable toxicity. Patients undergo bronchoscopy with biopsies and brushings at day 180.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Iloprost

2010

Completed Phase 4

~1180

Bronchoscopy

2002

Completed Phase 2

~2300