Pembrolizumab with Chemotherapy for Non-Small Cell Lung Cancer

Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])

Recruiting Phase 3 Interventional Study
Lung Non-Small Cell Carcinoma Lung Non-Small Cell Squamous Carcinoma Lung Non-Squamous Non-Small Cell Carcinoma Stage II Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,210 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for adults who have had surgery for certain stages of non-small cell lung cancer. Participants will receive a type of drug called pembrolizumab along with their usual chemotherapy treatment to help improve their chances of survival.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been completely removed by surgery.
  • I am fully recovered from my surgery.
  • I have a negative pregnancy test if I can get pregnant.
  • I have good overall health and my performance status is 0-1.

You may not be able to join if

  • I have uncontrolled health issues like serious infections or heart problems.
  • I have a history of severe pneumonia that required steroids.
  • I have had another cancer that is currently active.
  • I am pregnant or nursing.
  • I have a hypersensitivity to pembrolizumab.
  • I have had a live vaccine within the last 30 days.
  • I test positive for certain hepatitis infections.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ch…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * A female of childbearing potential is a sexually mature female who: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutiv…
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