SWOG S1403

Swog S1403:  A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Non-Small Cell Lung Cancer https://clinicaltrials.gov/ct2/show/NCT02438722?term=S1403&rank=1

Sponsor: SWOG

Primary Investigator:  Philip Lowry, MD

Primary Study Coordinator:  Cherokee Helms-Gleason, LPN

Number of Participants:  605

Length of Study:  3 years or until progression

What are Afatinib and Cetuximab?   Afatinib is already FDA-approved for use in advanced non-small lung cancer and cetuximab is FDA-approved for treating other types of cancer, but using them together is considered investigational. 

What type of study is this? S1403 is a phase 2/3 clinical trial for people who are about to start their treatment for non-small cell lung cancer which has spread to other parts of their body.

You may be able to participate in the S1430 trial if you:

  • confirmed diagnosed Stage IV or recurrent non-small cell lung cancer which has spread to other parts of your body
  • EGFR positive
  • must not have received any prior systemic anticancer therapy for advanced or metastatic disease.                     (Prior chemotherapy for non-metastatic disease is allowed)

Why is the S1430 trial being done?  The purpose of this study is to compare any good and bad effects of using afatinib along with cetuximab to using afatinib alone.  The addition of cetuximab to the usual afatinib could shrink your cancer, but it could also cause side effects.  This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

What is involved in the study?   If you eligible and are willing to participate in the S1403 trial, you will be randomly assigned (like flipping a coin) to one of two groups.

  1. You will receive the study drugs afatinib and cetuximab.  The combination of the two drugs is considered investigational.  Once every two weeks you will receive cetuximab which will be given into a vein.  Before receiving cetuximab, you will receive diphenhydramine hydrochloride (Benadryl) to help prevent a hypersensitivity reaction.  You will also take one afatinib tablet every day.  Afatinib is to be taken by mouth on an empty stomach (at least one hour before eating or two hours after a meal).  Every 28 days is considered a "cycle."
  2. You will receive afatinib alone.  You will take one afatinib tablet every day.  Afatinib is to be taken by mouth on an empty stomach (at least one hour before eating or two hours after a meal).  Every 28 days is considered a "cycle."

 What are the costs of the study? The afatinib and cetuximab will be supplied at no charge while you take part in this study whether you are in Group 1 or Group 2.  The cost of getting the cetuximab ready and giving it to you is not paid by the study sponsor so you or your insurance company may have to pay for this. Before you decide to be in the study, you should check with your health plan or insurance company to find out exactly what they will pay for.

 What are the benefits of being in the study?  It is not possible to know at this time if the study drugs/study approach is better than the usual approach so this study may or may not help you. This study will help researchers learn things that will help people in the future.

To inquire about trial eligibility or for additional information, please contact:

UPHS - Marquette Cancer Care: 906-225-3500   toll-free:  1-800-562-9753 ext. 3922

Cherokee Helms-Gleason, LPN:  906-225-7397   toll-free:  1-800-562-9753 ext. 7397

Jodi Nease, RN:  906-225-4687   toll-free: 1-800-562-9753 ext. 4687