A phase II study of durvalumab (MEDI4736) immediately after completion of chemoradiotherapy in unresectable stage III non–small cell lung cancer: TORG1937 (DATE study).

Authors

null

Shinji Nakamichi

Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan

Shinji Nakamichi , Kaoru Kubota , Toshihiro Misumi , Shuji Murakami , Tetsuro Kondo , Isamu Okamoto , Koichi Minato , Daijiro Harada , Kazutoshi Isobe , Hidetoshi Itani , Saori Takata , Hiroshi Wakui , Yuki Misumi , Satoshi Ikeda , Tetsuhiko Asao , Takeo Inoue , Shinobu Hosokawa , Yumiko Kobayashi , Yuichi Takiguchi , Hiroaki Okamoto

Organizations

Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan, Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan, Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan, Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan, Department of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota, Japan, Department of Thoracic Oncology and Medicine, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan, Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo, Japan, Department of Respiratory Medicine, Japanese Red Cross Ise Hospital, Ise, Japan, Department of Respiratory Medicine, Kyorin University School of Medicine, Tokyo, Japan, Division of Respiratory Diseases, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan, Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan, Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan, Department of Respiratory Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan, Department of Internal Medicine, Division of Respiratory Medicine, St. Marianna University School of Medicine, Kawasaki, Japan, Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan, Department of Pulmonary Medicine, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan, Department of Medical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan

Research Funding

Pharmaceutical/Biotech Company

Background: Concurrent chemoradiotherapy followed by durvalumab maintenance for up to 12 months is the standard of care for patients with unresectable stage III non-small cell lung cancer (NSCLC). However, the best timing of starting durvalumab after completion of chemoradiation has not been identified. Progression-free survival (PFS) and overall survival (OS) were better in the subgroup of patients administered durvalumab within 14 days after last radiation to randomization according to the PACIFIC study (Antonia SJ, et al. 2017, 2018 NEJM). Methods: This study was a prospective, single-arm, multicenter, phase II clinical trial. Eligibility criteria included patients with unresectable stage III NSCLC, ECOG PS 0-1, age < 75 years old. Patients who did not have disease progression after definitive concurrent chemoradiotherapy (CCRT) (chemotherapy: 2 cycles of platinum-based doublet chemotherapy, radiotherapy: 60 Gy/30 Fr) received durvalumab (10 mg/kg, every 2 weeks for up to 12 months) from the next day (allowed up to 5 days) after last radiation. The primary endpoint was 1-year PFS rate from registration assessed by an independent review committee. The planned sample size was 47 with a threshold value of 50% based on results of the PACIFIC study, an expected value of 63%, one-sided alpha of 20% and power of 80% in 1-year PFS rate. Results: From January 2020 to August 2020, 50 patients were enrolled from 16 institutions and 47 patients were evaluable for efficacy and safety. Forty-two patients received durvalumab maintenance therapy. Patient characteristics were: male/female 41/6; median age 65 (range 42-75); ECOG PS 0/1 28/19; IIIA/IIIB/IIIC 19/21/7. The 1-year PFS rate from registration was 75.0% (60% CI: 69.0 to 80.0). The 1-year OS rate from registration was 97.7% (95%CI: 84.6 to 99.7). ORR, median PFS and median OS were 78.7%, 14.2 months (95%CI: 13.4 to not reached (NR)) and NR, respectively. Grade 3/4 adverse events were pneumonitis (4.3%), neutropenia (44.7%), febrile neutropenia (4.3%). There was no treatment-related death. Conclusions: Our study met the primary endpoint. Durvalumab can be safely administered immediately after completion of CCRT for patients with unresectable stage III NSCLC, no additional or unexpected toxicity occurred as a reference to the PACIFIC study. Clinical trial information: jRCTs031190117.

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Local-Regional Non–Small Cell Lung Cancer

Clinical Trial Registration Number

jRCTs031190117

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 8536)

DOI

10.1200/JCO.2022.40.16_suppl.8536

Abstract #

8536

Poster Bd #

163

Abstract Disclosures