2018 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Type: Poster Session
Time: Sunday June 3, 8:00 AM to 11:30 AM
Location: Hall A
Nivolumab plus cisplatin/pemetrexed or cisplatin/gemcitabine as induction in resectable NSCLC.
Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
2018 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #187a)
J Clin Oncol 36, 2018 (suppl; abstr TPS8582)
Author(s): Nathaniel R. Evans, Scott Cowan, Charalambos Solomides, D. Craig Hooper, Larry Harshyne, Grace L. Lu-Yao, Hushan Yang, Linda Phan, Dawn Poller, Benjamin Leiby, Maria Werner-Wasik, Bo Lu, Jennifer Maria Johnson, Rita Susan Axelrod, Athanassios Argiris, Ralph Zinner; Thomas Jefferson University, Philadelphia, PA; Department of Pathology, Thomas Jefferson University, Philadelphia, PA; Thomas Jefferson University, Department of Neurological Surgery, Philadelphia, PA; Sidney Kimmel Cancer Center at Jefferson, Philadelphia, PA; The Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA; Thomas Jefferson University, Department of Pharmacology and Experimental Therapeutics, Philadelphia, PA, US; Thomas Jefferson University Hospital, Philadelphia, PA; Vanderbilt University Medical Center, Nashville, TN; Thomas Jefferson University, Department of Medical Oncology, Philadelphia, PA; Thomas Jefferson University, Department of Otolaryngology, Philadelphia, PA; Hygeia Hospital, Athens, Greece
Background: For patients (pts) with stage IB (≥4cm)-IIIA Non-small-cell lung cancer (NSCLC), multi-modality therapy yields a modest improvement in 5 year post-surgical overall survival (OS), with comparable benefit for induction and postoperative adjuvant chemotherapy (chemo). Induction can speed the discovery of promising regimens by using pathologic response as a surrogate for OS. About 20% of pts treated with induction chemo have major pathologic response (MPR) ( < 10% viable tumor) at primary and lymph nodes while pathologic complete responses (pCR) average 4%. MPR was strongly associated with improved OS (Hellmann MD, Lancet, 2014). PD-1 checkpoint inhibitors (CI), nivolumab (nivo), pembrolizumab (pembro), and the PD-L1 CI, atezolizumab, are established in advanced NSCLC as 2nd line therapy, and pembro is approved as a single agent as 1st line treatment of pts with PD-L1 high expressing tumors. In a phase III 1st line NSCLC study, pts with high mutational burden tumors had superior OS with nivo plus ipilimumab compared to doublet chemo. Pembro plus carboplatin with pemetrexed (P) was approved as 1st line therapy based on a randomized phase II study in advanced NSQ NSCLC showing improved clinical response and PFS compared to chemo alone with no increase in grade III toxicity. We therefore hypothesize that the addition of nivo to induction cisplatin (C) P or C gemcitabine (G) will increase the MPR rate over induction chemo alone compared to historical controls. Methods: This is an investigator initiated trial for pts with newly diagnosed clinical stage I-IIIA (stage I ≥ 4cm) SQ and NSQ NSCLC. Induction is C 75mg/m2 IV q 3w x 3 plus either P 500 mg/m2 IV q 3wks x 3 or G 1250mg/m2 IV d1, d8 q 3 wks x 3 plus nivo 360mg IV q 3w x 3. Surgery is planned 3 wks after the last dose. The primary outcome is MPR. Secondary outcomes include safety, pCR, overall clinical response rate, clinical CR, 1 year PFS, OS and exploratory outcomes assessing markers of immune bias. Enrollment will be 34 pts. Clinical trial information: NCT03366766