This phase III, randomized, placebo-controlled, double-blind study determined whether motesanib improved progression-free survival (PFS) compared with placebo in combination with paclitaxel and carboplatin (P/C) in East Asian patients with stage IV/recurrent nonsquamous non–small-cell lung cancer.

Patients were randomly assigned (1:1) to receive oral motesanib 125 mg or placebo once daily plus paclitaxel 200 mg/m² IV and carboplatin area under the concentration-time curve 6 mg/mL ⋅ min IV for up to six 3-week cycles. Random assignment was stratified by epidermal growth factor receptor status, region, and weight loss in the 6 months before assignment. The primary end point was PFS, the key secondary end point was overall survival, and other secondary end points were objective response rate, time to tumor response, duration of response, and adverse events (AEs).

Four hundred one patients were assigned to receive motesanib plus P/C (n = 197) or placebo plus P/C (n = 204). Median PFS was 6.1 v 5.6 months for motesanib versus placebo (stratified log-rank test P = .0825; stratified hazard ratio, 0.81; 95% CI, 0.64 to 1.03; P = .0820); median overall survival was not reached versus 21.6 months (P = .5514). In secondary analyses, the objective response rate was 60.1% v 41.6% (P < .001); median time to tumor response, 1.4 v 1.6 months, and median duration of response, 5.3 v 4.1 months. Incidence of grade ≥ 3 AEs (86.7% v 67.6%) and AEs that led to drug discontinuation (32.7% v 14.2%) were higher with motesanib than with placebo. AEs reported more frequently with motesanib were GI disorders, hypertension, and gallbladder related.

Motesanib plus P/C did not significantly improve PFS versus placebo plus P/C in East Asian patients with stage IV/recurrent nonsquamous non–small-cell lung cancer.

这项III期随机，安慰剂对照，双盲研究确定了在东亚IV期/复发性非鳞状非肿瘤患者中，与安慰剂联合紫杉醇和卡铂（P / C）相比，莫替沙尼能否改善无进展生存期（PFS）。 –小细胞肺癌。

患者被随机分配（1：1）接受口服莫替沙尼125 mg或安慰剂，每天一次，再加上紫杉醇200 mg / m ² IV和浓度-时间曲线下6 mg / mL⋅min IV的卡铂面积，最多连续6个3周周期。随机分配按分配前6个月的表皮生长因子受体状态，区域和体重减轻进行分层。主要终点为PFS，关键次要终点为总体生存，其他次要终点为客观缓解率，对肿瘤缓解的时间，缓解持续时间和不良事件（AE）。

401名患者被分配接受莫替沙尼加P / C（n = 197）或安慰剂加P / C（n = 204）。莫替沙尼vs安慰剂的中位PFS为6.1 v 5.6个月（分层对数秩检验P = .0825；分层危险比为0.81； 95％CI为0.64至1.03；P = .0820）；与21.6个月相比，未达到中位总体生存期（P = .5514）。在次要分析中，客观回应率为60.1％对41.6％（P <.001）；位时间为肿瘤响应，1.4 v 1.6个月，和响应的时间中位数，5.3 v 4.1个月。≥3级AE发生率（86.7％v莫替沙尼组比安慰剂组高（67.6％）和导致药物停用的不良事件（32.7％vs 14.2％）。据报道，使用莫替沙尼的AE更频繁地与胃肠道疾病，高血压和胆囊有关。

在东亚IV期/复发性非鳞状非小细胞肺癌东亚患者中，Motesanib加P / C与安慰剂加P / C相比，PFS并未显着改善。