Non⁠–⁠small cell lung cancer (NSCLC)

RESULTS FOR A TREATMENT PLAN WITH KEYTRUDA For early-stage NSCLC that can be removed by surgery

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KEYTRUDA can be used as part of a treatment plan that may help prevent early-stage NSCLC from coming back after surgery

KEYTRUDA may be used in combination with chemotherapy medicines before surgery when you have early-stage non–small cell lung cancer, which can be removed by surgery, and then continued alone after surgery to help prevent lung cancer from coming back.

Results from a clinical trial with KEYTRUDA

A clinical trial of 797 people with early-stage non–small cell lung cancer compared the following 2 groups receiving different treatments:

Group 1 (KEYTRUDA + chemotherapy)

200 mg of KEYTRUDA every 3 weeks plus chemotherapy before surgery

Then: 200 mg of KEYTRUDA alone every 3 weeks after surgery

Group 2 (chemotherapy alone)

Placebo* every 3 weeks plus chemotherapy before surgery

Then: Placebo alone every 3 weeks after surgery

*Placebo = an inactive treatment given instead of an active treatment.

Related topics
Side effects
How does KEYTRUDA work?
Is KEYTRUDA right for you for early-stage NSCLC?

More people lived longer

100%
0%
72%
64%
287 out of 397 people were alive
256 out of 400 people were alive

KEYTRUDA + chemotherapy,† then KEYTRUDA alone

Placebo + chemotherapy,† then placebo alone

†Cisplatin and either pemetrexed or gemcitabine

More people did not have their cancer get worse or come back

100%
0%
65%
49%
258 out of 397 people did not have their lung cancer get worse or come back
195 out of 400 people did not have their lung cancer get worse or come back

KEYTRUDA + chemotherapy,† then KEYTRUDA alone

Placebo + chemotherapy,† then placebo alone

†Cisplatin and either pemetrexed or gemcitabine

The phrase “cancer did not get worse or come back” refers to event-free survival (EFS), which is the length of time once treatment begins and a person survives until experiencing certain complications or events. These may include cancer growing or spreading that would prevent surgery, or cancer growing or returning after surgery.

More people who received KEYTRUDA + chemotherapy had no cancer cells found at the time of surgery compared to people who received chemotherapy alone

In the clinical trial, 18.1% (72 out of 397) of patients treated with KEYTRUDA in combination with chemotherapy that contains platinum and another chemotherapy medicine before surgery had no cancer cells found at the time of surgery compared to 4.0% (16 out of 400) of patients treated with chemotherapy alone before surgery.

More people who received KEYTRUDA + chemotherapy had less than or equal to 10% of cancer cells found at the time of surgery compared to people who received chemotherapy alone

In the clinical trial, 30.2% (120 out of 397) of patients treated with KEYTRUDA in combination with chemotherapy that contains platinum and another chemotherapy medicine before surgery had less than or equal to 10% of cancer cells found at the time of surgery compared to 11.0% (44 out of 400) of patients treated with chemotherapy alone before surgery.

Understanding different types of results

There’s a lot to learn about your diagnosis. Your doctor may use several terms to talk about your treatment goals, and it’s important you understand them.

Living longer

One way your doctor may determine which medicine to choose is overall survival (OS). This is a measurement of time from the start of treatment and measures the length of time a person is alive.

Time without the cancer getting worse or coming back

Your doctor may look at the length of time, once treatment begins, until a person experiences certain complications or events. This is called event-free survival (EFS). These may include cancer growing or spreading that would prevent surgery, or cancer growing or returning after surgery.

Pathologic complete response

The phrase “no live cancer cells found at the time of surgery” refers to pathologic complete response (pCR), which is measured at the time of surgery. This is when the cancer could no longer be found when lung tissue and lymph nodes were examined under a microscope.

Major pathologic response

The phrase “less than or equal to 10% of live cancer cells found at the time of surgery” refers to major pathologic response (mPR), which is measured at the time of surgery. This is when less than or equal to 10% of live cancer cells can be found when lung tissue and lymph nodes were examined under a microscope.

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Is KEYTRUDA right for you for early-stage NSCLC?
About KEYTRUDA
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Side effects

FDA-Approved Indications

KEYTRUDA is a prescription medicine used to treat a kind of lung cancer called non–small cell lung cancer (NSCLC).

  • KEYTRUDA may be used with the chemotherapy medicines pemetrexed and a platinum as your first treatment when your lung cancer has spread (advanced NSCLC) and is a type called “nonsquamous” and your tumor does not have an abnormal “EGFR” or “ALK” gene.
  • KEYTRUDA may be used with the chemotherapy medicines carboplatin and either paclitaxel or paclitaxel protein-bound as your first treatment when your lung cancer has spread (advanced NSCLC), and is a type called “squamous.”
  • KEYTRUDA may be used alone as your first treatment when your lung cancer has not spread outside your chest (stage III) and you cannot have surgery or chemotherapy with radiation, or your NSCLC has spread to other areas of your body (advanced NSCLC), and your tumor tests positive for “PD-L1” and does not have an abnormal “EGFR” or “ALK” gene.
  • KEYTRUDA may also be used alone for advanced NSCLC if you have tried chemotherapy that contains platinum and it did not work or is no longer working and, your tumor tests positive for “PD-L1” and if your tumor has an abnormal “EGFR” or “ALK” gene, you have also received an “EGFR” or “ALK” inhibitor medicine that did not work or is no longer working.
  • KEYTRUDA may be used in combination with chemotherapy that contains platinum and another chemotherapy medicine before surgery when you have early-stage NSCLC, which can be removed by surgery, and then continued alone after surgery to help prevent your lung cancer from coming back.
  • KEYTRUDA may be used alone as a treatment in adults for your lung cancer to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery and you have received platinum-based chemotherapy, and you have stage IB and your tumor(s) is 4 cm or greater in size, stage II, or stage IIIA NSCLC.

PD-L1 = programmed death ligand 1; EGFR = epidermal growth factor receptor; ALK = anaplastic lymphoma kinase.

Important Safety Information

KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen any time during treatment or even after your treatment has ended.

Call or see your health care provider right away if you develop any signs or symptoms of the following problems or if they get worse. These are not all of the signs and symptoms of immune system problems that can happen with KEYTRUDA:

Lung problems: cough, shortness of breath, or chest pain.

Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; or severe stomach-area (abdomen) pain or tenderness.

Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); or bleeding or bruising more easily than normal.

Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.

Kidney problems: decrease in the amount of your urine; blood in your urine; swelling of your ankles; loss of appetite.

Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or in your nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes.

Problems can also happen in other organs and tissues. Signs and symptoms of these problems may include: chest pain; irregular heartbeat; shortness of breath; swelling of ankles; confusion; sleepiness; memory problems; changes in mood or behavior; stiff neck; balance problems; tingling or numbness of the arms or legs; double vision; blurry vision; sensitivity to light; eye pain; changes in eyesight; persistent or severe muscle pain or weakness; muscle cramps; low red blood cells; bruising.

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feeling like passing out, fever, and back pain.

Rejection of a transplanted organ or tissue. Your health care provider should tell you what signs and symptoms you should report and they will monitor you, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA. Your health care provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your health care provider will check you for these problems during treatment with KEYTRUDA. They may treat you with corticosteroid or hormone replacement medicines. They may also need to delay or completely stop treatment with KEYTRUDA if you have severe side effects.

Before you receive KEYTRUDA, tell your health care provider if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ or tissue transplant, including corneal transplant, or have had or plan to have a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic); have had radiation treatment in your chest area; have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.

If you are pregnant or plan to become pregnant, tell your health care provider. KEYTRUDA can harm your unborn baby. If you are able to become pregnant, you will be given a pregnancy test before you start treatment. Use effective birth control during treatment with KEYTRUDA and for 4 months after your last dose of KEYTRUDA. Tell them right away if you think you may be pregnant or you become pregnant during treatment with KEYTRUDA.

Tell your health care provider if you are breastfeeding or plan to breastfeed. It is not known if KEYTRUDA passes into your breast milk. Do not breastfeed during treatment with KEYTRUDA and for 4 months after your last dose of KEYTRUDA.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Common side effects of KEYTRUDA when used alone include feeling tired; pain, including pain in muscles; rash; diarrhea; fever; cough; decreased appetite; itching; shortness of breath; constipation; bones or joints and stomach-area (abdominal) pain; nausea; and low levels of thyroid hormone.

In children, when KEYTRUDA is used alone, fever, vomiting, headache, stomach area (abdominal) pain, and low levels of white blood cells and red blood cells (anemia) are more common than in adults.

Common side effects of KEYTRUDA when given with certain chemotherapy medicines include feeling tired or weak; nausea; constipation; diarrhea; decreased appetite; rash; vomiting; cough; trouble breathing; fever; hair loss; inflammation of the nerves that may cause pain, weakness, and paralysis in the arms and legs; swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina; mouth sores; headache; weight loss; stomach-area (abdominal) pain; joint and muscle pain; trouble sleeping; bleeding, blisters, or rash on the palms of your hands and soles of your feet; urinary tract infection; and low levels of thyroid hormone.

Common side effects of KEYTRUDA when given with chemotherapy with radiation therapy medicines include feeling tired or weak; nausea; constipation; diarrhea; decreased appetite; rash; vomiting; cough; trouble breathing; fever; hair loss; inflammation of the nerves that may cause pain, weakness, and paralysis in the arms and legs; swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina; mouth sores; headache; weight loss; stomach-area (abdominal) pain; joint and muscle pain; trouble sleeping; bleeding, blisters, or rash on the palms of your hands and soles of your feet; urinary tract infection; and low levels of thyroid hormone.

Common side effects of KEYTRUDA when given with enfortumab vedotin include rash; tingling or numbness of the arms or legs; feeling tired; itching; diarrhea; hair loss; weight loss; decreased appetite; dry eye; nausea; constipation; changes in sense of taste; and urinary tract infection.

Common side effects of KEYTRUDA when given with chemotherapy and bevacizumab include tingling or numbness of the arms or legs; hair loss; low red blood cell count; feeling tired or weak; nausea; low white blood cell count; diarrhea; high blood pressure; decreased platelet count; constipation; joint aches; vomiting; urinary tract infection; rash; low levels of thyroid hormone; and decreased appetite.

Common side effects of KEYTRUDA when given with axitinib include diarrhea; feeling tired or weak; high blood pressure; liver problems; low levels of thyroid hormone; decreased appetite; blisters or rash on the palms of your hands and soles of your feet; nausea; mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina; hoarseness; rash; cough; and constipation.

These are not all the possible side effects of KEYTRUDA. Talk to your health care provider for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for KEYTRUDA and discuss it with your doctor. The physician Prescribing Information also is available.

About KEYTRUDA

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