PROSPECT-LUNG: A National Clinical Trials Network Trial Advancing Pragmatic Innovation in Cancer Clinical Trials.

By incorporating pragmatic features, including simplified eligibility criteria, streamlined protocol, and data collection, the PROSPECT-Lung trial, CTIU2317-A082304-S2402 Perioperative versus Adjuvant Systemic Therapy in Patients with Resectable NSCLC, paves the way forward as a model for enhancing clinical trial efficiency and feasibility, while maintaining scientific rigor.

通过整合实用特性，包括简化的入选标准、精简的协议和数据收集，PROSPECT-Lung试验，CTIU2317-A082304-S2402围手术期与辅助性全身治疗在可切除NSCLC患者中的研究，开辟了提高临床试验效率和可行性的道路，同时保持了科学严谨性。

Methods

PROSPECT-Lung (CTIU2317-A082304-S2402) is a pragmatic, phase III, open-label, randomized trial comparing 3-year real-world event-free survival and overall survivalusing approved perioperative and adjuvant immunotherapy-based treatment strategies in patients with resectable NSCLC.

PROSPECT-Lung (CTIU2317-A082304-S2402) 是一项实用的、III期、开放标签、随机试验，比较了在可切除的非小细胞肺癌（NSCLC）患者中使用批准的围手术期和辅助免疫治疗策略的3年真实世界无事件生存和总生存。

Protocol length and data collection elements were compared with Alliance A081801, Integration of Immunotherapy into Adjuvant Therapy for Resected NSCLC: ALCHEMIST CHEMO-IO (ClinicalTrials.gov Identifier: NCT04267848), a phase III trial in the same disease setting, to quantify streamlining efforts.

与 Alliance A081801（临床试验注册号：NCT04267848），即在相同疾病背景下进行的III期试验“将免疫治疗整合到切除的NSCLC辅助治疗中：ALCHEMIST CHEMO-IO”相比，比较了方案长度和数据收集元素，以量化简化努力。

Results

Relative to A081801, PROSPECT-Lung achieved major reductions in trial complexity.

与A081801相比，PROSPECT-Lung在试验复杂性方面实现了重大降低。

Protocol length decreased from 88 to 30 pages (65%), and data fields per patient were reduced from 2523 to 438 (82.6%), driven by streamlined summary versus cycle-by-cycle data collection.

方案长度从88页减少到30页（减少了65%），每名患者的数据显示字段从2523个减少到438个（减少了82.6%），这是通过简化总结数据收集而非逐周期收集数据所驱动的。

These efficiencies translate to estimated site workload reductions from 210 hours per patient in A081801 to 36.5 hours in PROSPECT-Lung.

这些效率转化为从A081801的每位患者210小时的估计站点工作量减少到PROSPECT-Lung的36.5小时。

At full accrual, this equates to more than 190,000 hours saved in chart review, data entry, documentation, and quality control.

在完全招满时，这相当于在病历审查、数据录入、文档记录和质量控制方面节省了超过190,000小时。

Conclusions

By broadening eligibility and streamlining logistics, PROSPECT-Lung reduces burden for patients, investigators, and sites while preserving scientific integrity.

通过扩大资格标准和简化物流，PROSPECT-Lung减轻了患者、研究者和试验地点的负担，同时保持了科学的完整性。

This pragmatic approach, when appropriate and possible, provides a replicable model for future cancer trials, promoting efficiency, accessibility, and real-world relevance.

这种实用的方法，在适当和可能的情况下，为未来的癌症试验提供了一个可复制的模型，促进了效率、可及性和现实世界的相关性。

gov_identifier

NCT06632327 (CTIU2317-A082304-S2402).

NCT06632327 (CTIU2317-A082304-S2402).