INCREASE STUDY: Immunotherapy Plus Chemoradiotherapy for Operable NSCLC

By: Vanessa A. Carter, BS
Posted: Monday, December 2, 2024

Idris Bahce, MD, PhD, of Amsterdam University Medical Center, and colleagues conducted the phase II INCREASE study to evaluate whether neoadjuvant chemoradiotherapy combined with ipilimumab plus nivolumab is a viable treatment option for patients with resectable and borderline-resectable non–small cell lung cancer (NSCLC). Published in the Journal for ImmunoTherapy of Cancer, the results of this trial suggest this treatment is well tolerated, with an acceptable safety profile and anticancer activity.

“This study revealed that the use of neoadjuvant dual immunotherapy with chemoradiotherapy in T3–4N0–2 NSCLC resulted in enhanced pathological complete response and major pathological response with acceptable surgical morbidity,” the investigators concluded. “Patients with pathological complete response demonstrated higher proliferation and activation rates of CD8-positive T cells and lower rates in proliferative regulatory T cells; these observations warrant further investigation.”

This single-arm trial enrolled 30 patients with operable T3–4N0–2 NSCLC who did not harbor oncogenic drivers. Participants received platinum-doublet concurrent chemoradiotherapy, 1 mg/kg of ipilimumab, and 360 mg of nivolumab on day 1 of treatment, followed by nivolumab plus chemotherapy 3 weeks later. Thoracic radiotherapy was administered in once-daily doses of 2 Gy, up to a total of 50 or 60 Gy; resection was performed 6 weeks after radiotherapy was completed.

Approximately 70% of patients reported treatment-related adverse events of grade 3 to 4, and one patient reported grade 5 pneumonitis. There was one death attributed to COVID-19 infection that did not appear to be related to treatment. Pathologic complete response was achieved in 50% of patients, and 63% attained a major pathologic response; 58% and 73% of patients who underwent resection achieved these responses, respectively. All 26 patients who underwent surgery had a pathologic complete resection. Of note, one patient who did not achieve a pathologic complete response developed postoperative melanoma.

Disclosure: For full disclosures of the study authors, visit jitc.bmj.com.

Journal for ImmunoTherapy of Cancer

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