Non-Small Cell Lung Cancer Coverage from Every Angle

Neoadjuvant Combination Immunotherapy for Operable Lung Cancer: NEOSTAR Trial Update

By: Noelle Cutter, PhD
Posted: Tuesday, May 25, 2021

In the phase II randomized NEOSTAR trial, single and combined neoadjuvant immune checkpoint inhibitor therapy yielded an improvement in major pathologic response rates in patients with stage I to III non–small cell lung cancer (NSCLC). Boris Sepesi, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues reported an increase in immunologic memory and tumor immune cell infiltration with the combination neoadjuvant therapy of nivolumab plus ipilimumab. The results of the study were published in Nature Medicine.

“The NEOSTAR trial results set the stage for evaluating the role of dual immunotherapy added to neoadjuvant chemotherapy, which we are currently exploring, and expediting the investigation of novel agents in the perioperative setting,” said Tina Cascone, MD, PhD, also of MD Anderson Cancer Center, in an institutional press release.

A total of 44 patients with surgically resectable stage IA to IIIA NSCLC were randomly assigned into two treatment arms: three doses of nivolumab alone or three doses of nivolumab plus one dose of ipilimumab. A total of 41 patients completed the three-dose treatment, 37 had surgery on trial, and 2 underwent surgery off trial. A total of 23 patients received three doses of nivolumab alone, and 21 received three doses of nivolumab plus one dose of ipilimumab. Each arm was compared against historical controls of neoadjuvant chemotherapy.

Among the 37 patients who had surgical resection on the study, higher major pathologic response rates (50% vs. 24%), fewer viable tumor cells (9% vs. 50%), and better pathologic response rates (38% vs. 10%) were reported in the combination arm compared with the monotherapy arm. At a median follow-up of 22 months, median overall survival and lung cancer–related recurrence-free survival were not reached. The investigators noted that toxicities were manageable overall, with no new safety concerns with either drug.

Disclosure: For full disclosures of the study authors, visit

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