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

Area of Science:

• Oncology
• Clinical Trial Design
• Translational Research

Background:

• Traditional clinical trials face inefficiencies due to extensive data collection, restrictive eligibility, and lengthy protocols.
• These factors increase costs, hinder patient accrual, and are exacerbated by staffing shortages and operational burdens.
• There is a need for more efficient and feasible clinical trial designs without compromising scientific rigor.

Purpose of the Study:

• To evaluate the PROSPECT-Lung trial as a model for enhancing clinical trial efficiency and feasibility in resectable non-small cell lung cancer.
• To compare the protocol length and data collection elements of PROSPECT-Lung with a traditional trial (Alliance A081801) in the same disease setting.
• To quantify the streamlining efforts and their impact on trial complexity and site workload.

Main Methods:

• PROSPECT-Lung is a pragmatic, phase III, open-label, randomized trial comparing immunotherapy-based treatment strategies.
• The trial focuses on 3-year event-free survival and overall survival in patients with resectable non-small cell lung cancer.
• Protocol length and data fields were compared against Alliance A081801 to assess streamlining.

Main Results:

• PROSPECT-Lung achieved significant reductions in trial complexity compared to A081801.
• Protocol length decreased by 65% (88 to 30 pages), and data fields per patient were reduced by 82.6% (2523 to 438).
• Estimated site workload reduced from 210 hours per patient to 36.5 hours, saving over 190,000 hours at full accrual.

Conclusions:

• The PROSPECT-Lung trial demonstrates that broadening eligibility and streamlining logistics reduce burden for patients, investigators, and sites.
• This pragmatic approach maintains scientific integrity and offers a replicable model for future cancer trials.
• The PROSPECT-Lung model promotes efficiency, accessibility, and real-world relevance in oncology research.