Phase III Study of Gemcitabine, Erlotinib, and Nab-paclitaxel for Advanced Basal-like Pancreatic Adenocarcinoma Compared to Standard Triplet Therapy for Classical Pancreatic Adenocarcinoma

What this Trial Is About

Researchers are evaluating whether adding a low dose of EGFR blocking drugs to the standard chemotherapy combination of gemcitabine and nab-paclitaxel GnP is safe, tolerable, and helpful for people with advanced pancreatic cancer. The study focuses on tumors classified as either basal-like or classical using the PurIST tool. Participants with basal-like tumors will receive the combination of GnP plus erlotinib in Phase I to find the safest dose. In Phase II, basal-like patients will be randomly assigned to receive either GnP alone or GnP with erlotinib, with possible testing of new drug combinations if approved during the study. Classical tumor patients will receive standard treatments recommended by their doctors or participate in other clinical trials. Participants with basal-like tumors will be treated with gemcitabine 1000 mgm2 intravenously on days 1 and 15, nab-paclitaxel 125 mgm2 intravenously on days 1 and 15, and erlotinib 50 mg orally daily during Phase I and possibly Phase II. Those with classical tumors will receive treatments such as NALIRIFOX or Folfirinox as decided by their physicians. The study may include up to about 52 basal-like patients in Phase I, about 82 basal-like patients in Phase II, and at least 52 classical patients, with the option to enroll more if needed. Participants will be screened using the PurIST classifier to determine tumor type before treatment. Researchers will monitor adverse events, dose-limiting toxicities, overall survival, progression-free survival, and tumor response over two years. Safety is assessed from the first day of treatment through 28 days after the last dose. The study also tracks long-term outcomes such as survival time and tumor progression. Participation involves regular treatment visits, medical evaluations, and follow-up assessments to understand the effects of the treatments tested.

Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel