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Ketorolac before Surgery for the Treatment of Stage I-II Non-small Cell Lung Cancer or Stage III Renal Cell Cancer

Cancer Type
Lung Cancer
Trial Phase
Phase I
18 - 80 Years, Male and Female
Study Type
Protocol IDs
WINSHIP4977-20 (primary)
Study Sponsor
Emory University Hospital/Winship Cancer Institute


This phase I trial studies the side effects of ketorolac before surgery in treating patients with stage I-II non-small cell lung cancer or stage III renal cell cancer. Surgical trauma increases the production of prostaglandins and thromboxanes, which have tumor-promoting and immunosuppressive activities and reduce the activity of natural killer cells, which impairs the ability of the immune system to keep cancer cells in check. However, if given just before tissue injury, non-steroidal anti-inflammatory drugs, such as ketorolac, may be able to block the production of prostaglandins/thromboxanes and boost the activity of natural killer cells, thereby decreasing the risk of cancer coming back.


I. To test the safety of a single pre-incisional dose of 30 mg ketorolac in patients undergoing surgery for stage I/II non-small cell lung cancer (NSCLC) and stage III renal cell cancer (RCC), as these are the stages of cancer most likely to develop a recurrence while still noting a benefit from the ketorolac.

I. To evaluate blood and tissue samples pre- and post-operatively to assess the impact of ketorolac on key inflammatory biomarkers using a standard cytokine panel.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ketorolac intravenously (IV) prior to standard of care surgery. Patients additionally undergo blood sample collection throughout the study.

ARM II: Patients undergo standard of care surgery. Patients additionally undergo blood sample collection throughout the study.

After completion of study treatment, patients are followed up for 90 days and then renal cell cancer patients are followed up at 1 and 2 years post surgery.


  1. Age = 18 years and = 80 years
  2. Pathology-proven or suspected stage 1 or 2 NSCLC and stage 3 T3N0 RCC, that require surgical resection as the treatment of choice
  3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  4. Ability to understand and the willingness to sign an informed written consent

Treatment Sites in Georgia

Emory Clinic

1365 Clifton Road NE
Atlanta, GA 30322

Emory University Hospital - Atlanta

1364 Clifton Road NE
Atlanta, GA 30322

Emory University Hospital - Midtown

550 Peachtree Street NE
Atlanta, GA 30308

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.