Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI) -Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO®] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS.

Status:

Recruiting

Phase 3 Icon

Trial Phase

The investigational immunotherapy is being studied in a large group of patients to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the investigational immunotherapy to be used safely.

Eligibility

About the Trial

All patients who enroll in the trial will receive medication while on the study.

  • 50% will receive pembrolizumab along with pemetrexed and carboplatin* or cisplatin*
  • 50% will receive placebo along with pemetrexed and carboplatin* or cisplatin*

*Your doctor will decide which chemotherapy treatment (carboplatin or cisplatin) is best for you. 

Neither you nor the study doctor will know what group you are assigned. You will not know if you are receiving pembrolizumab or placebo.

In case of a health emergency, the study doctor can get this information.

Trial Purpose
17

US Trial Locations

Clinical trial sites are places such as hospitals or clinics where the trial is being conducted.

See Locations

National Trial Reference Number

NCT03515837 Read More at clinicaltrials.gov

What Can You Do Next?

If you would like to learn about this clinical trial or see if you can participate, you can:

Contact Our Trial Info Center

To learn more, call 1-888-577-8839

Discuss With Your Doctor

Print this page or Email it to your doctor to discuss at your next visit

Tip: To help with understanding of some clinical terms used on the page, select an underlined term to see what they mean.

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

Condition

The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Non-small Cell Lung Cancer

Age range

18 — no age maximum

Gender(s)

All

Trial Purpose

The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO®] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS.

Important information

Participating in a clinical trial is an important decision. Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.

Trial Locations

    Location
    Status
  • Monterey, California, United States, 93940
    Recruiting
  • Orange, California, United States, 92868
    Recruiting
  • Santa Rosa, California, United States, 95403
    Recruiting
  • Evanston, Illinois, United States, 60201
    Recruiting
  • Sioux City, Iowa, United States, 51101
    Recruiting
  • Edina, Minnesota, United States, 55435
    Recruiting
  • Lake Success, New York, United States, 11042
    Recruiting
  • White Plains, New York, United States, 10601
    Recruiting
  • Portland, Oregon, United States, 97213
    Recruiting
  • Portland, Oregon, United States, 97227
    Recruiting
  • Dallas, Texas, United States, 75390
    Recruiting
  • Salt Lake City, Utah, United States, 84106
    Recruiting
  • Charlottesville, Virginia, United States, 22903
    Recruiting
  • Milwaukee, Wisconsin, United States, 53226
    Recruiting
  • New York, New York, United States, 10022
    Recruiting
  • Kansas City, Missouri, United States, 64111
    Recruiting
  • Dallas, Texas, United States, 75235
    Recruiting

How to Learn More

When speaking to your doctor, please have the trial reference number available. You can also call 1-888-577-8839 for more information.

Print or email this page.

Trial reference number

A unique identification code given to each clinical trial registered on clinicaltrials.gov.

Keynote number

A unique identification code used by the sponsor to identify a specific trial.
Keynote-789

Official title

A description of the clinical trial that the trial sponsor and clinicians use to identify a specific trial and its purpose.
A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)

Call 1-888-577-8839 to contact our trial information center

Clinical Trials: Important Information to Consider

There is a lot to consider when deciding whether to participate in a clinical study. Any clinical study includes risks, which the study doctor will review with you. Make sure you understand the risks before participating.