PROSPECT-Lung: A Pragmatic Approach to a Vital Question in NSCLC

Immune checkpoint inhibitor (ICI) therapy has transformed how we treat patients with non-small cell lung cancer (NSCLC). For those with resectable, early-stage NSCLC, adding ICIs to chemotherapy is now part of standard treatment. 

But the Food and Drug Administration has approved adjuvant, perioperative, and neoadjuvant chemoimmunotherapy regimens for these patients. And to date, there have been no definitive comparisons to learn which of these approaches is optimal, leading to better outcomes for patients.

Enter PROSPECT-Lung. It pits adjuvant and perioperative chemoimmunotherapy regimens for these patients head-to-head in a phase 3 comparison with dual primary endpoints: real-world event free survival and overall survival.

Co-led by the Alliance and SWOG (with Alliance as administrative lead), the trial was the first to come out of the NCI’s Clinical Trials Innovation Unit. Study chairs are Daniel Morgensztern, MD, for the Alliance and Raid Aljumaily, MD, for SWOG.

Formally titled “Perioperative versus Adjuvant Systemic Therapy in Patients with Resectable Non-Small Cell Lung Cancer” (aka CTIU2317-A082304-S2402), the trial looks to enroll 1,100 patients with resectable stage IIA to IIIB non-small cell lung cancer.

In its highly pragmatic design, the study builds on many of the lessons learned from the success of S2302 Pragmatica-Lung.

• Data collection has been minimized, which should make it easier for community-based sites to take part in the study.
  • Case report forms have been streamlined following electronic medical record standards.
  • Data are collected only on baseline demographics and tumor characteristics, administered treatment, tumor progression and relapse, type of resection, and overall survival.
  • Adverse events need to be reported only when they cause hospitalization, treatment discontinuation, or a patient’s death.
• Patients with performance status from 0 to 2 are eligible, which should ensure an enrolled group representing the full population of patients with the disease.
• The study protocol does not specify individual treatment regimens. Instead, treating physicians can choose a regimen based on the standard of care at the time of enrollment – any regimen approved by the FDA or included in the NCCN guidelines for these patients.
• Surgical resection is performed according to the treating institution’s own guidelines.
• Lab tests and imaging are performed and reviewed locally, and disease response or progression is assessed locally, without the need to use RECIST criteria.

The study is a model of clinical efficiency, and we have the numbers to back up that claim: a recently published analysis compares the trial’s pragmatic features to parallel features in an earlier lung trial, quantifying the benefits using metrics such as workload reduction for enrolling clinical sites.

To learn more about PROSPECT-Lung, check out the FAQs for site staff and investigators, and use this one-slide summary when presenting the trial to staff at your site.

Resources are also available to help you with patient recruitment:

• recruitment flyer/poster for making patients aware of the study (also in Spanish)
• patient information handout (also in Spanish)

Finally, if you still have questions about opening the trial at your site, please reach out to SWOG study chair Dr. Raid Aljumaily via communications@swog.org.  

PROSPECT-Lung tackles an essential question that only the cooperative groups are likely to answer definitively. And it’s redefining what pragmatic clinical trials in cancer can look like. 

Is it open at your site, for your patients with early-stage NSCLC?