Efficacy and Safety of Pembrolizumab With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage IIB or IIIA Non-small Cell Lung Cancer

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by blinded central pathologist or by imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by blinded independent central review (BICR); and 2) overall survival (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 chemotherapy and pembrolizumab before surgery and pembrolizumab only after surgery
  • 50% will receive chemotherapy and placebo before surgery and placebo only after surgery

Neither you nor the study doctor will know what you are getting. In case of a health emergency, the study doctor can get this information.

Trial Purpose
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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

NCT03425643 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.
Early-stage Non-small Cell Lung Cancer

Age range

18 — no age maximum

Gender(s)

All

Trial Purpose

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by blinded central pathologist or by imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by blinded independent central review (BICR); and 2) overall survival (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
  • Gilbert, Arizona, United States, 85234
    Recruiting
  • Goodyear, Arizona, United States, 85338
    Recruiting
  • Anaheim, California, United States, 92801
    Recruiting
  • Monterey, California, United States, 93940
    Recruiting
  • Santa Monica, California, United States, 90404
    Recruiting
  • Santa Rosa, California, United States, 95403
    Recruiting
  • Stanford, California, United States, 94305
    Recruiting
  • Newark, Delaware, United States, 19713
    Recruiting
  • Jacksonville, Florida, United States, 32224
    Recruiting
  • Newnan, Georgia, United States, 30265
    Recruiting
  • Elk Grove Village, Illinois, United States, 60007
    Recruiting
  • Harvey, Illinois, United States, 60426
    Recruiting
  • Fort Wayne, Indiana, United States, 46845
    Recruiting
  • Iowa City, Iowa, United States, 52242
    Recruiting
  • Ashland, Kentucky, United States, 41101
    Recruiting
  • Worcester, Massachusetts, United States, 01655
    Recruiting
  • Detroit, Michigan, United States, 48202
    Recruiting
  • Lansing, Michigan, United States, 48912
    Recruiting
  • Rochester, Minnesota, United States, 55905
    Recruiting
  • Billings, Montana, United States, 59102
    Recruiting
  • Omaha, Nebraska, United States, 68198-7680
    Recruiting
  • Albany, New York, United States, 12208
    Recruiting
  • Bronx, New York, United States, 10461
    Recruiting
  • Stony Brook, New York, United States, 11794-9447
    Recruiting
  • White Plains, New York, United States, 10601
    Recruiting
  • Tulsa, Oklahoma, United States, 74133
    Recruiting
  • Harrisburg, Pennsylvania, United States, 17109
    Recruiting
  • Philadelphia, Pennsylvania, United States, 19124
    Recruiting
  • Pittsburgh, Pennsylvania, United States, 15232
    Recruiting
  • Pittsburgh, Pennsylvania, United States, 15240
    Recruiting
  • Charlottesville, Virginia, United States, 22903
    Recruiting
  • Fairfax, Virginia, United States, 22031
    Recruiting
  • Pittsburgh, Pennsylvania, United States, 15212
    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-671

Official title

A description of the clinical trial that the trial sponsor and clinicians use to identify a specific trial and its purpose.
A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage IIB or IIIA Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

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.