First-Line Camrelizumab Versus Placebo Plus Chemotherapy With or Without Radiotherapy for Brain Metastases in NSCLC: The CTONG 2003 Randomized Placebo-Controlled Trial.

To our knowledge, CTONG 2003 is the first randomized controlled trialto evaluate camrelizumab for untreated BM of NSCLC.

据我们所知，CTONG 2003 是首个评估卡瑞利珠单抗用于未经治疗的非小细胞肺癌脑转移的随机对照试验。

Methods

CTONG 2003 is a multicenter, randomized, double-blind, placebo-controlledtrial. Treatment-naïve NSCLC with BM, negative for EGFR mutations and ALK fusions, were randomized 1:1 to receive either camrelizumab or placebo, plus platinum-doublet chemotherapy for four to six cycles, followed by maintenance therapy with camrelizumab or placebo with or without pemetrexed for up to 31 cycles.

CTONG 2003 是一个多中心、随机、双盲、安慰剂对照试验。治疗前未接受过治疗的非小细胞肺癌伴有脑转移，且 EGFR 突变和 ALK 融合均为阴性的患者，按照 1:1 的比例随机接受卡瑞利珠单抗或安慰剂治疗，同时接受 4 至 6 个周期的铂类双药化疗，之后根据情况最多进行 31 个周期的卡瑞利珠单抗或安慰剂维持治疗，可联合或不联合培美曲塞。

Radiotherapy was administered for BM, if necessary, within 42 days of the first treatment dose.

如果需要，脑转移的放射治疗在首次治疗剂量后的 42 天内进行。

The co-primary endpoints were intracranial progression-free survival(iPFS) and progression-free survival(PFS).

主要终点是颅内无进展生存期(iPFS)和无进展生存期(PFS)。

The planned enrollment included 200 patients, but recruitment was terminated early because of therapeutic paradigm shifts globally.

原计划招募200名患者，但由于全球治疗范式的转变，提前终止了招募。

Results

Between May 28, 2021, and July 21, 2023, 60 patients were randomized, with 32 assigned to the camrelizumab group and 28 to the placebo group.

2021年5月28日至2023年7月21日期间，共有60名患者被随机分配，其中32名被分配到卡瑞利珠单抗组，28名被分配到安慰剂组。

The median iPFS was 12.7 months (95% confidence interval[CI]: 7.1-25.3) for camrelizumab versus 9.9 months (95% CI: 6.3-14.6) for placebo (hazard ratio= 0.45, 95% CI: 0.21-0.96).

卡瑞利珠单抗组的中位无进展生存期（iPFS）为12.7个月（95%置信区间[CI]: 7.1-25.3），而安慰剂组为9.9个月（95% CI: 6.3-14.6）（风险比=0.45，95% CI: 0.21-0.96）。

The median PFS was 9.7 months (95% CI: 6.6-14.0) for camrelizumab versus 6.7 months (95% CI: 4.1-8.6) for placebo (hazard ratio= 0.57, 95% CI: 0.29-1.11).

卡瑞利珠单抗的中位无进展生存期为9.7个月（95%置信区间：6.6-14.0），而安慰剂组为6.7个月（95%置信区间：4.1-8.6）（风险比=0.57，95%置信区间：0.29-1.11）。

Grade 3 or higher treatment-related adverse events occurred in 65.6% and 46.4% of the respective groups, mainly neutrophil count decrease and anemia.

分别有65.6%和46.4%的患者出现了3级或更高级别的治疗相关不良事件，主要为中性粒细胞计数减少和贫血。

Conclusions

Despite early termination, camrelizumab demonstrated a trend toward improved iPFS and PFS in the BM of NSCLC with an acceptable safety profile.

尽管早期终止，卡瑞利珠单抗在非小细胞肺癌脑转移中显示出改善的iPFS和PFS的趋势，并具有可接受的安全性剖面。

trial_registration

ClinicalTrials.gov Identifier: NCT04768075.

ClinicalTrials.gov 注册号：NCT04768075。