Alliance, Allarity Launch Lung Cancer Trials as Phase I Sites Consolidate
Alliance launches Phase III trial for stage I NSCLC immunotherapy; Allarity starts Phase 2 SCLC trial. Phase I NSCLC trial sites consolidate at top U.S. sites, prompting FDA representation concerns.
The Alliance for Clinical Trials in Oncology has launched a new national Phase III trial, Alliance A082302, to evaluate whether the immunotherapy drug atezolizumab can prevent recurrence in patients with stage I non-small cell lung cancer (NSCLC) after surgery. The trial aims to enroll 336 participants who will be randomly assigned to either standard follow-up observation or standard follow-up plus atezolizumab. Atezolizumab works by helping the immune system recognize and destroy cancer cells that may linger after surgery.
Separately, Allarity Therapeutics announced that the first patients have been dosed with stenoparib and temozolomide in a VA-funded investigator-initiated Phase 2 trial for relapsed small cell lung cancer (SCLC). The trial is conducted in collaboration with the U.S. Department of Veterans Affairs and is fully funded through the VA’s Special Emphasis Panel on Precision Oncology. Patient recruitment is ongoing across 11 VA medical centers throughout the United States. The company’s CEO stated that prior studies combining PARP inhibitors and temozolomide were limited by toxicities, but stenoparib is well tolerated and may be ideal for combination.
Meanwhile, a study presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 found that the distribution of Phase I clinical trials for NSCLC is consolidating at top-performing U.S. sites. Between 2020 and 2024, the number of unique U.S. sites conducting such trials decreased by 44%, with trials increasingly concentrated at the top 20 highest-volume sites largely located in major cities. The U.S. Food and Drug Administration (FDA) has been working to improve representation in clinical trials, and the FDA’s Oncologic Drug Advisory Committee (ODAC) has convened meetings to address insufficient enrollment and underrepresentation.
The analysis, which examined interventional, industry-sponsored Phase I trials listed on ClinicalTrials.gov between January 2020 and December 2024, found that 555 trials opened for 8,393 trial instances across 47 countries. The United States accounted for 45% of trial instances, followed by China (11%) and Spain (8%). U.S. trial instances increased from 819 in 2020 to 955 in 2022, then declined to 566 by the end of 2024. The number of unique U.S. trial sites decreased from 395 to 223, while the top 20 sites maintained a median of 7 to 11 trials annually. The top 20 sites were largely in big cities with an average population of more than 1.9 million.
Factors contributing to this consolidation include increasingly complex Phase I trial protocols, safety profiles of new oncology modalities, increased regulatory and compliance burdens, and a competitive landscape that favors established sites with proven track records. The consolidation may result in more limited access to clinical trials.