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Pre-Incisional Ketorolac for Lung Cancer

Phase < 1

Recruiting

Led By Viraj Master, MD, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Pathology-proven or suspected stage 1 or 2 NSCLC and Stage 3 tumor stage 3, node stage 0 (T3N0) RCC, that require surgical resection as the treatment of choice

Must not have

Immunocompromised status

History of cancer in the 3 years prior to surgery (except for basal-cell carcinoma of the skin or cervical neoplasia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 1, day 3 (if admitted to hospital), day 7, day 28

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trialwill study if pre-surgery ketorolac can reduce the risk of distant tumor spread, potentially improving survival. 56 patients will get ketorolac, w/ 10 additional patients in a control group. Results will inform future studies on recurrence & survival.

Who is the study for?

This trial is for adults with early-stage non-small cell lung cancer or renal cell carcinoma who need surgery. They should be in good enough health to understand and agree to the study, not have had certain cancers recently, no severe kidney issues, allergies to NSAIDs, bleeding disorders, or be over 80 years old.

What is being tested?

The study tests if giving a drug called Ketorolac before surgery can help reduce inflammation and lower the chance of cancer spreading after tumor removal. Out of 76 patients enrolled, most will receive Ketorolac pre-surgery while about 20 won't as a comparison group.

What are the potential side effects?

Ketorolac may cause stomach ulcers, kidney problems in those already at risk, allergic reactions if sensitive to NSAIDs (like ibuprofen), and increased bleeding due to its blood-thinning effects.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

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My lung or kidney cancer is in an early stage and surgery is recommended.

Exclusion Criteria

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

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My immune system is weakened.

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I haven't had any cancer except for skin or cervical in the last 3 years.

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I am scheduled for or have had a pneumonectomy.

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I cannot take NSAIDs due to allergies, kidney issues, bleeding disorders, stomach ulcers, or being over 80.

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My lung scan shows mostly non-solid spots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 1, day 3 (if admitted to hospital), day 7, day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 1, day 3 (if admitted to hospital), day 7, day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 1, day 3 (if admitted to hospital), day 7, day 28 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Blood Transfusion Among Ketorolac Group

Incidence of Clinically Significant Hematoma Development Among Ketorolac Group

Incidence of Postoperative Morbidity Rate Among Ketorolac Group

+2 more

Secondary study objectives

Change in Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Levels

Change in Interferon (INF)-gamma Levels

Change in Interleukin-1 alpha (IL-1alpha) Levels

+8 more

Other study objectives

Change in Flow Cytometry

Change in Single Cell RNA Sequencing

Change in T-Cell Receptor (TCR) Sequencing

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Preoperative KetorolacExperimental Treatment1 Intervention

Participants randomized to receive ketorolac prior to surgery for stage I/II NSCLC and stage III RCC. Participants will receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia will be administered.

Group II: Control GroupActive Control1 Intervention

Participants randomized to the control group receiving the standard of care during surgery for stage I/II NSCLC and stage III RCC. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia will be administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.

0 / 7Eligibility criteria met