Protocol S2433, Randomized Phase III Study of Second-Line Chemotherapy with or without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma

This study is being done to answer the following question: 

• Does the combination of panitumumab, a targeted therapy, with the usual chemotherapy help 
  people with advanced or metastatic pancreatic cancer and tumors without KRAS mutations live 
  longer compared to the usual chemotherapy alone?

Targeted therapy is a type of cancer treatment that focuses on specific changes in cancer cells to 
stop them from growing, unlike chemotherapy, which affects all fast-growing cells. Panitumumab 
is a targeted therapy that works by blocking a protein called EGFR, which helps cancer cells grow. 
By attaching to EGFR, it can slow or stop the growth of certain cancers, like colorectal cancer, 
while mostly affecting cancer cells instead of healthy ones.

We are doing this study because we want to find out if this combination is better or worse than the 
usual approach for advanced pancreatic cancer without KRAS mutations. The usual approach, 
which is chemotherapy alone, is defined as the care most people get for advanced or metastatic 
pancreatic cancer.

For more information, visit: https://clinicaltrials.gov/study/NCT06998940

8081 Innovation Park Drive
Fairfax, VA 22031

• Participant must be ≥ 18 years old at the time of randomization.
• Participants must have a histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of the pancreas.
• Participants must have previously documented KRAS wild type (i.e., absence of any KRAS mutation) and BRAF V600E wild type (i.e., absence of a BRAF V600E mutation) status determined by tumor tissue-based NGS assay. The testing must be done within a laboratory with CLIA, ISO/IEC, CAP, or similar certification status
• Participants must have Zubrod Performance Status of 0-2 
• Participants must have a complete medical history and physical exam within 28days prior to randomization.
• Participants must have received only one line of prior systemic cytotoxic chemotherapy for locally advanced or metastatic PDA, and have radiographically progressed, refractory, or intolerant to this therapy. 

• Participants must not have known mutations in PTEN, NRAS, EGFR extracellular domain exons 1-16, no amplifications of HER2 and MET, and no gene fusions of RET, NTRK1, and ALK by tumor tissue-based NGS analysis.
• Participants must not have known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 28 days before randomization
• Participants must not have prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
• Participants must not have prior treatment with an EGFR tyrosine kinase inhibitor (e.g., erlotinib).
• Participants must not have received any pancreatic anticancer therapy (e.g., standard of care or investigational chemotherapy, molecularly targeted therapy, or radiation) within 14 days prior to randomization.
• Participants must not have a known contraindication to receiving chosen chemotherapy backbone at the planned doses in accordance with the local approved label.