2019 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Metastatic
Type: Poster Session
Time: Sunday June 2, 8:00 AM to 11:00 AM
Location: Hall A
MS201944-0170: A phase IIa study to investigate the clinical activity and safety of avelumab in combination with cetuximab plus gemcitabine and cisplatin in patients with advanced squamous NSCLC.
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #441b)
J Clin Oncol 37, 2019 (suppl; abstr TPS9123)
Author(s): Fortunato Ciardiello, Manuel Cobo Dols, Oscar Juan Vidal, Luis G. Paz-Ares, Javier de Castro Carpeño, Enriqueta Felip, Rosario Garcia Campelo, Gyorgy Losonczy, Zsuzsanna Szalai, David Vicente, Andreas Schröder, Frank Beier, Prasad Bhandge, Gabriella Galffy; Università Degli Studi della Campania Luigi, Naples, Italy; Hospital Regional Universitario de Malaga, Málaga, Spain; Hospital Universitari i Politécnic La Fe, Valencia, Spain; Hospital Universitario 12 de Octubre, Madrid, Spain; Hospital Universitario HM Madrid Sanchinarro, Madrid, Spain; Hospital Universitari Vall d'Hebron, Barcelona, Spain; Complejo Hospitalario Universitario A Coruña, Coruna, Spain; Semmelweis Egyetem, Budapest, Hungary; Petz Aladar Megyei Oktato Korhaz, Gyor, Hungary; Hospital Universitario Virgen Macarena, Seville, Spain; Merck KGaA, Darmstadt, Germany; Pulmonology Hospital Torokbalint, Torokbalint, Hungary
Background: Preclinical studies have demonstrated that cetuximab plus chemotherapy results in immunogenic cell death and an increase in CD8+ T cells in the tumor microenvironment. Avelumab (an anti–PD-L1 antibody) has previously shown antitumor activity in NSCLC. We hypothesize that the combination of cetuximab with platinum-based chemotherapy and avelumab may have synergistic antitumor activity. Methods: This phase IIa, single-arm, multicenter study is investigating the clinical activity and safety of avelumab in combination with cetuximab plus gemcitabine and cisplatin in patients with advanced squamous NSCLC who are treatment naive in the advanced setting (NCT03717155). Eligibility criteria include histologically confirmed stage IV, metastatic or recurrent NSCLC with squamous histology, with no prior systemic therapy for metastatic NSCLC, no prior therapy with any antibody/drug targeting T-cell coregulatory proteins, and ECOG PS of 0 to 1. Patients with a tumor harboring an activating EGFR mutation or ALK rearrangement are excluded. Patients will receive doublet chemotherapy (cisplatin 75 mg/m2 on day 1, gemcitabine 1250 mg/m2 on days 1 and 8), cetuximab on days 1 (250 mg/m2) and 8 (500 mg/m2), and avelumab 800 mg on days 1 and 8 for a total of four 3-week cycles. Thereafter, avelumab (800 mg) and cetuximab (500 mg/m2) will be administered as maintenance treatment Q2W until disease progression, unacceptable toxicity, or withdrawal. Enrollment in a safety run-in, which will evaluate the safety and tolerability of avelumab in combination with cetuximab plus gemcitabine and cisplatin, is planned for the first 6 patients. Enrollment began on October 30, 2018. Study enrollment will continue until approximately 40 evaluable patients have been recruited. The primary endpoint is confirmed best overall response per RECIST 1.1 by investigator assessment. Secondary endpoints include safety (NCI CTCAE v5.0) and tolerability of the combination, duration of response, survival, and tumor biomarkers. The study is ongoing at sites in Hungary and Spain. Clinical trial information: NCT03717155