A trial looking at LY2940680 for small cell lung cancer

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer

Small cell lung cancer

Status:

Closed

Phase:

Phase 1/2

This trial is looking at a new drug called LY2940680 with carboplatin and etoposide chemotherapy for small cell lung cancer that has spread beyond the lungs.

Doctors usually use chemotherapy to treat small cell lung cancer that has spread beyond the lungs (extensive disease). One combination of drugs they use is carboplatin and etoposide. This combination works but researchers are always looking for ways to improve treatment.

LY2940680 is a type of biological therapy called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

In this trial some people will have LY2940680 with carboplatin and etoposide. And some will have a dummy drug (placebo Open a glossary item ) with carboplatin and etoposide.

The aims of this trial are to find out

The best dose of LY2940680 to give with carboplatin and etoposide
How well LY2940680, carboplatin and etoposide works for people with extensive stage small cell lung cancer
What are the side effects of LY2940680, carboplatin and etoposide

Who can enter

You may be able to enter this trial if you

Have small cell lung cancer that has spread beyond the lung (extensive stage)
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Have at least 1 area of cancer that is 20mm in size or more on an ordinary CT scan or, 10mm or more on a spiral CT scan (your doctor can tell you this)
Have adequate blood tests results
Are able to swallow capsules
Are willing to use reliable contraception during treatment and for 6 months afterwards if you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if

You also have non small cell lung cancer (NSCLC)
Your cancer has spread to your brain or spinal cord and you have symptoms or use steroids to control symptoms. If you had radiotherapy for your cancer spread more than 2 weeks ago, have not used steroids for more than a week and your condition is stable, you may be able to take part
You have had a treatment that reaches your whole body (systemic treatment )
You have had radiotherapy to more than a quarter of your bone marrow (your doctor can tell you this)
You have had radiotherapy to all of your chest or all of the area between your hip bones (pelvis)
You have had radiotherapy in the past 2 weeks
You are already taking part in another clinical trial or have done so in the past month
You have already had LY2940680
You have an infection
You have had a heart attack in the past 6 months or have another serious heart problem
You have had a vaccine for yellow fever in the past month
You have had another cancer in the past 5 years apart from carcinoma in situ of the cervix, non melanoma skin cancer or prostate cancer that hasn’t spread to another part of your body
You have a build up of fluid between your chest wall and lungs (pleural effusion) or in your abdomen (ascites) that can’t be controlled
You have lost a lot of weight in the past 6 weeks
You are taking any other cancer medication apart from hormone therapy for prostate cancer that hasn’t spread or hormone therapy for breast cancer
You are taking any other medication that affects body proteins called cytochrome P enzymes (your doctor can tell you this)
You are pregnant or breastfeeding

Trial design

This is a phase 1/2 trial. It will recruit 132 people. The trial is in 2 parts.

In part 1, the first few people will have a low dose of LY2940680 with carboplatin and etoposide. If they don’t have any serious side effects, the next few people will have a higher dose. And so on, until they find the best dose of LY2940680 to give with carboplatin and etoposide. This is called a dose escalation study.

Part 2 is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

The treatment groups are

Carboplatin, etoposide and LY2940680 (you have double the chance of being put into this group)
Carboplatin, etoposide and dummy drug (placebo)

LY2940680 trial diagram

LY2940680 and the dummy drug are capsules. You take them 4 times every day for 3 weeks and then have a week of not taking them. Each 4 week period is called a cycle of treatment.

You have etoposide and carboplatin as an injection into a vein. You have etoposide on the first 3 days of each 4 week cycle of treatment. You have carboplatin on the first day of each cycle. You have 6 cycles of treatment.

After 6 cycles your doctor may talk to you about having radiotherapy to your head to kill off any cancer cells that may have spread to your brain. This is called prophylactic cranial irradiation (PCI). And then they may talk to you about continuing with LY2940680 or the dummy drug. You continue having treatment as long as it is helping you and the side effects aren’t too bad.

The researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item . They will also ask for blood samples and some tiny samples of your skin. They will use these to find out how well the treatment works. You must agree to give these samples if you take part in the trial.

If you take part in the 2nd part of the trial, the trial team will ask you to fill out a questionnaire before you start treatment, every 4 weeks during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.