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Diclofenac for the Treatment of Patients with Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy

Phase 2

Waitlist Available

Led By Jennifer W Carlisle

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

* Capable of signing informed consent

* Age ≥ 18 years at time of study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from diagnosis to death from any cause up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This phase II trial tests how well diclofenac works in treating patients non-small cell lung cancer (NSCLC) that may have spread from where it first started (primary site) to other places in the body (metastatic) on single agent immunotherapy. Diclofenac, a type of non-steroidal anti-inflammatory (NSAID), blocks the body's production of a substance that causes inflammation and may decrease tumor growth and improve the effectiveness of immunotherapy. Immunotherapy with pembrolizumab, atezolizumab, nivolumab or cemiplimab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving diclofenac may kill more tumor cells in patients with metastatic NSCLC on single agent immunotherapy.

Eligible Conditions

Non-Small Cell Lung Cancer
Lung Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from diagnosis to death from any cause up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from diagnosis to death from any cause up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from diagnosis to death from any cause up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Clinical benefit rate (CBR)

Secondary study objectives

Duration of response (DOR)

Incidence of adverse events (AEs)

Objective response rate (ORR)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (diclofenac, immunotherapy)Experimental Treatment10 Interventions

Patients receive diclofenac PO BID and standard of care immunotherapy with pembrolizumab, atezolizumab, nivolumab or cemiplimab on day 1 of each cycle. Cycles repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and CT, PET, or MRI on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Biospecimen Collection

2004

Completed Phase 3

~2030