European journal of cancer (Oxford, England : 1990) · 2025
Atezolizumab with carboplatin plus nab-paclitaxel combination therapy for TTF-1 negative advanced nonsquamous non-small cell lung cancer: A multicenter, single-arm phase 2 trial (F1NE TUNE, LOGiK 2102).
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Shiraishi Yoshimasa, Shimose Takayuki, Tachihara Motoko, Tsuchiya-Kawano Yuko, Morinaga Ryotaro, Inoue Hiroyuki, Toi Yukihiro, Yamada Tadaaki, Yamaguchi Masafumi, Kashiwabara Kosuke, Tobino Kazunori, Ishii Hidenobu, Sakata Yoshihiko, Inaba Megumi, Nakashima Kazuhisa, Chibana Kenji, Fukui Tomoya, Izumi Miiru, Saito Ryota, Ishii Hiroshi, Omori Shota, Ogusu Shinsuke, Furuyama Kazuto, Miura Satoru, Harada Taishi, Okamoto Isamu
Аннотация
BACKGROUND: Individuals with thyroid transcription factor-1 (TTF-1)-negative nonsquamous non-small cell lung cancer (NSCLC) have a poor prognosis. There have been no prospective studies targeting TTF-1-negative nonsquamous NSCLC.
METHODS: This multicenter, single-arm phase 2 study enrolled chemotherapy-naïve individuals with TTF-1-negative advanced nonsquamous NSCLC to receive four cycles of atezolizumab in combination with carboplatin plus nab-paclitaxel, followed by atezolizumab alone. The primary endpoint was progression-free survival (PFS).
RESULTS: Between June 2022 and March 2024, 52 patients (41 male and 11 female) with a median age of 68.0 years were enrolled. Thirty-three patients had adenocarcinoma and 19 had nonadenocarcinoma. Nineteen, 30, and 3 patients were current, former, and never-smokers, respectively. The PD-L1 tumor proportion score was < 1 % in 22 cases, 1-49 % in 18 cases, ≥ 50 % in 11 cases, and unknown in 1 case. The median PFS was 4.9 months (80 % confidence interval [CI], 4.3-5.9 months). The lower limit of the 80 % CI did not exceed the prespecified threshold of 4.5 months; therefore, the study did not meet its primary endpoint. The median overall survival was 13.2 months (95 % CI, 10.3-27.2 months). The response rate was 56.9 % (95 % CI, 43.3-69.5 %). There were no new safety signals.
CONCLUSIONS: This first prospective study of individuals with TTF-1-negative advanced nonsquamous NSCLC has provided evidence for the efficacy and safety of the combination of carboplatin plus nab-paclitaxel with atezolizumab in such patients. The prognosis of TTF-1-negative advanced nonsquamous NSCLC remains poor, however, warranting further treatment development.
METHODS: This multicenter, single-arm phase 2 study enrolled chemotherapy-naïve individuals with TTF-1-negative advanced nonsquamous NSCLC to receive four cycles of atezolizumab in combination with carboplatin plus nab-paclitaxel, followed by atezolizumab alone. The primary endpoint was progression-free survival (PFS).
RESULTS: Between June 2022 and March 2024, 52 patients (41 male and 11 female) with a median age of 68.0 years were enrolled. Thirty-three patients had adenocarcinoma and 19 had nonadenocarcinoma. Nineteen, 30, and 3 patients were current, former, and never-smokers, respectively. The PD-L1 tumor proportion score was < 1 % in 22 cases, 1-49 % in 18 cases, ≥ 50 % in 11 cases, and unknown in 1 case. The median PFS was 4.9 months (80 % confidence interval [CI], 4.3-5.9 months). The lower limit of the 80 % CI did not exceed the prespecified threshold of 4.5 months; therefore, the study did not meet its primary endpoint. The median overall survival was 13.2 months (95 % CI, 10.3-27.2 months). The response rate was 56.9 % (95 % CI, 43.3-69.5 %). There were no new safety signals.
CONCLUSIONS: This first prospective study of individuals with TTF-1-negative advanced nonsquamous NSCLC has provided evidence for the efficacy and safety of the combination of carboplatin plus nab-paclitaxel with atezolizumab in such patients. The prognosis of TTF-1-negative advanced nonsquamous NSCLC remains poor, however, warranting further treatment development.