Trial Information

Phase I/II Trial of Image-Guided, Intensity-Modulated Scanning Beam Proton Therapy (IMPT) With Simultaneous Integrated Boost (SIB) Dose Escalation to the Gross Tumor Volume (GTV) With Concurrent Chemotherapy for Stage II/III Non-Small Cell Lung Cancer (NSCLC)

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study
group based on when you join this study. Up to 4 groups of 3 participants will be enrolled
in the Phase I portion of the study, and up to 25 participants will be enrolled in Phase II.

If you are enrolled in the Phase I portion, the dose of radiation therapy you receive will
depend on when you joined this study. The first group of participants will receive the
lowest dose level of radiation therapy. Each new group will receive a higher dose of
radiation therapy than the group before it, if no intolerable side effects were seen. This
will continue until the highest tolerable dose of radiation therapy is found.

If you are enrolled in the Phase II portion, you will receive radiation therapy at the
highest dose that was tolerated in the Phase I portion.

Radiation Therapy Administration:

You will first go through the standard radiation treatment planning procedure, called the
marking session. This will include a PET/CT or CT scan of the lung. A cradle will then be
made to hold you in the treatment position. After the marking session, a radiation plan
will be made.

Receiving IMPT SIB treatments is very similar to the way a CT scan is performed. You will
lie on a table and the treatment machine rotates around you without touching your body.

You will receive up to 6 weeks of proton therapy given 1 time a day, 5 days a week (Monday
through Friday).

Each daily treatment should take about 20-30 minutes to complete. Most of this time is used
to position you correctly before the machine is turned on. The actual time used to give the
radiation should take about 3-5 minutes each day.

Chemotherapy:

You will also receive chemotherapy as part of the standard of care for the disease. The
drugs you receive will depend on the type of disease and what the study doctor thinks is in
your best interest. You will sign a separate consent form to receive these drugs that
includes their potential risks and benefits, as well as how they are given.

Symptom Questionnaire:

You will complete a symptom questionnaire. This will be done on the following schedule.

- before chemoradiation beings

- each week during chemoradiation

- each week until 16 weeks after chemoradiation is complete

- every other week from Week 16 until 12 weeks after chemoradiation is complete

- at your follow-up visits

The symptom questionnaire should take about 10 minutes to complete each time.

Study Visits:

At least 1 time each week during chemoradiation (chemotherapy and radiation):

- You will have a physical exam.

- You will be asked about any side effects you may have had.

- Blood (about 2 teaspoons) will be drawn for routine tests.

Length of Treatment:

You may continue receiving study treatment for up to 6 weeks. You will no longer be able to
receive the study treatment if the disease gets worse, if intolerable side effects occur, or
if you are unable to follow study directions.

Follow-Up Visits:

After you have completed chemoradiation, the study staff will call you 1 time each month to
ask you about any symptoms you may have until 6 months after chemoradiation. Each phone
call should last about 10 minutes.

You will have your first follow-up visit 4-8 weeks after you have completed chemoradiation.
You will have additional follow-up visits every 3-4 months from then on.

At your first and second follow-up visit:

- Blood (about 1 teaspoon) will be drawn for routine tests.

- You will have PET/CT scans and SPECT scans to check your lungs and heart if the study
doctor thinks it is needed.

The remaining follow-up visits will include standard tests and procedures that the doctor
thinks are needed. For example, PET/CT and SPECT scans will be repeated any time the study
doctor thinks they are needed.

This is an investigational study. Proton therapy by IMPT is delivered using FDA-approved
and commercially available methods. It is investigational to use SIB of IMPT to learn if it
is a better way to give a higher dose of treatment to the tumor while not damaging as much
of the healthy tissue around it.

Up to 55 patients will take part in this multicenter study. Up to 50 will be enrolled at MD
Anderson.