Clinical Trial Summary (S2433)

Studying Chemotherapy With or Without Panitumumab for Advanced Pancreatic Cancer Without KRAS Mutations

What is the purpose of this clinical trial?

This trial is for people with advanced pancreatic cancer that doesn’t have a mutation (change) in a gene called KRAS. The study asks whether the medicine panitumumab can help chemotherapy work better for this group of patients.

The study will compare 2 treatment approaches:

          New treatment approach
                                                                            vs.
      chemotherapy + panitumumab

      Usual treatment approach

             chemotherapy

This trial is set up to find out:

  • If adding panitumumab to chemotherapy helps people live longer
  • If adding panitumumab to chemotherapy helps keep the cancer from growing or spreading
  • What side effects this treatment approach might cause

Why is this trial important?

Pancreatic cancer can be very hard to treat. But past studies have found that some pancreatic cancer treatments may work better in people who have cancer without a KRAS gene change. This study is looking at a possible new treatment approach for these patients: adding panitumumab to standard treatment with chemotherapy.

Panitumumab blocks a protein called EGFR to help keep cancer cells from growing. Studies have shown that adding other EGFR-blocking drugs to chemotherapy may help this group of patients live longer. This study will help researchers find out if that’s true when panitumumab is added to chemotherapy.

Who can be in this trial?

This trial is for adults age 18 or older who have pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer.

This trial may be for people who:

  • Don’t have a KRAS or BRAF V600E gene change
  • Have cancer that has spread outside the pancreas or can’t be treated with surgery
  • Received chemotherapy as part of their first treatment for the cancer

This trial is not for people who:

  • Were previously treated with an anti-EGFR antibody (like panitumumab or cetuximab) or an EGFR tyrosine kinase inhibitor (like erlotinib)
  • Have cancer that has spread to the brain or have cranial epidural disease (unless it’s be1enof 2 treated and is stable)
  • Are pregnant or breastfeeding

Talk to your doctor to learn more about who can join the study.

What treatments will I get?

A computer will randomly assign you to one of 2 study groups. Your doctor won’t have control over which group you’re assigned to. This helps make sure the study results are fair and reliable.

Group 1: chemotherapy + panitumumab

  • You’ll get a combination of chemotherapy drugs that are approved by the Food and Drug Administration (FDA) for treating advanced pancreatic cancer.
  • You’ll also get panitumumab. Panitumumab is approved by the FDA for treating other types of cancer.

Group 2: chemotherapy

  • You’ll get a combination of chemotherapy drugs that are approved by the FDA for treating advanced pancreatic cancer.

You and your doctor will decide which combination of chemotherapy drugs you’ll get during the study. You’ll choose from 3 different combinations.

You’ll get the chemotherapy drugs and panitumumab through an IV (a needle placed into a vein in your arm). Many of the drugs are given once every 2 weeks. Talk to your doctor to find out exactly when you’ll get each drug.

How long will I be in the trial?

You’ll have visits with your study doctor for 3 years from the time you start the study so they can see how you’re feeling and if the cancer has gotten worse. During this time, you’ll keep receiving the study treatment unless the cancer grows or spreads or the side effects become so bad that you decide to stop.

Are there costs? Will I get paid?

Panitumumab is provided for free in the study. To learn more about what costs will and won’t be covered, talk to your health care provider and insurance provider.

You will not be paid for joining the study.

Where can I find more information about this trial?

  • Talk with your health care provider
  • Call the National Cancer Institute at 1-800-4-CANCER
  • Go to www.ClinicalTrials.gov and search the national clinical trial number: NCT06998940
  • For a list of trial locations, visit swog.org/NCI-S2433

Key Information

Information your doctor or trial navigator may need to help you.

Protocol Number
S2433
NCT Number
NCT06998940
Full Trial Title
Randomized Phase III Study of Second-Line Chemotherapy with or without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Trial Sponsors
SWOG Cancer Research Network
Publication Date