RecruitingPhase 3NCT06998940

Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations

Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma

Sponsor

SWOG Cancer Research Network

Enrollment

94 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Unresectable Pancreatic Adenocarcinoma Locally Advanced Pancreatic Adenocarcinoma Metastatic Pancreatic Adenocarcinoma

Summary

This phase III trial compares the effect of adding panitumumab to standard chemotherapy (with nanoliposomal Irinotecan, leucovorin, and 5-fluorouracil \[5-FU\] or irinotecan, leucovorin, and 5-FU or nab-paclitaxel and gemcitabine) versus standard chemotherapy alone in treating patients with KRAS wild type (WT) pancreatic ductal adenocarcinoma that cannot be removed by sugery (unresectable) or that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as nanoliposomal irinotecan, leucovorin, 5-FU, irinotecan, nab-paclitaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding panitumumab to standard chemotherapy may be effective in treating patients with unresectable, locally advanced, or metastatic KRAS WT pancreatic ductal adenocarcinoma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding panitumumab — a targeted antibody that blocks a protein called EGFR — to standard chemotherapy improves outcomes in patients with pancreatic cancer that has spread or cannot be removed and whose tumors do not have a KRAS mutation (which makes them potentially responsive to EGFR-targeted therapy). **You may be eligible if...** - You are 18 or older with confirmed ductal adenocarcinoma of the pancreas - Your tumor has been tested and does NOT have a KRAS mutation or BRAF V600E mutation (KRAS wild type) - Your cancer is unresectable (cannot be surgically removed) or has spread to other organs - You have received exactly one prior chemotherapy regimen for your advanced cancer - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - You have brain metastases that are active or unstable - You have previously received anti-EGFR therapy (such as cetuximab or panitumumab) or EGFR-blocking pills - You are pregnant or breastfeeding - You have another active cancer that could interfere with this study - You have certain other genetic mutations in your tumor (PTEN, NRAS, EGFR, HER2, MET, etc.) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT scan

DRUGFluorouracil

Given IV

DRUGGemcitabine

Given IV

DRUGIrinotecan

Given IV

DRUGIrinotecan Sucrosofate

Given IV

DRUGLeucovorin

Given IV

DRUGNab-paclitaxel

Given IV

BIOLOGICALPanitumumab

Given IV

OTHERQuestionnaire Administration

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