NCT04267848From ClinicalTrials.govRecruiting

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])

Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO)

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

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: National Cancer Institute (NCI)
Enrolment target: 1,210
Started: 16 June 2020
Main results due: 31 January 2027
Study sites: 1151
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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 consecutive months)
* Local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)
* Local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only)
* Local testing of PD-L1 immunohistochemistry (IHC) using one of the following assays: DAKO 22C3, DAKO 28-8, EIL3N or SP263
* Completely resected stage IIA, IIB IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) (squamous or non-squamous) with negative margins (complete R0 resection). Patients will be staged according to the 8th edition of the American Joint Committee on Cancer (AJCC) Staging Manual, 2017

  * Note: Patients with pathologic N2 disease, completely resected, are eligible. However, patients known to have N2 disease prior to surgery are not eligible; guidelines do not recommend up-front surgery for this population
* Complete recovery from surgery. Registration to A081801 must be 30-77 days following surgery
* No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis
* No prior allogeneic tissue/solid organ transplant
* Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements
* No current pneumonitis or history of (non-infectious) pneumonitis that required steroids
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
* No active auto-immune disease that has required systemic treatment within the last 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects

  * Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required
* No patients with a "currently active" second malignancy that is progressing or has required active treatment within the last 3 years. Participants with non-melanoma skin cancers, low grade or low-risk cancers, or stage I malignancies not requiring systemic therapy (e.g., prostate cancer requiring only observation or superficial bladder cancer), or carcinoma in situ (e.g., breast carcinoma or cervical cancer in situ) that have undergone potentially curative therapy are eligible
* No hypersensitivity (\>= grade 3) to pembrolizumab and/or any of its excipients
* No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed
* No known hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection or known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive)
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 8 gm/dl
* Calculated (Calc.) creatinine clearance \>= 45 mL/min
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)

What this study is about

In the sponsor’s own words, from the registry.

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. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.

Study sites(1151)

Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Suspended
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Suspended
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Suspended
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Suspended
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Suspended
Anchorage Oncology Centre
Anchorage, Alaska, United States
Suspended
Katmai Oncology Group
Anchorage, Alaska, United States
Suspended
Providence Alaska Medical Center
Anchorage, Alaska, United States
Suspended
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Suspended
Kingman Regional Medical Center
Kingman, Arizona, United States
Suspended
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
Suspended
Banner Boswell Medical Center
Sun City, Arizona, United States
Recruiting
Banner University Medical Center - Tucson
Tucson, Arizona, United States
Active, not recruiting
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Active, not recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
Suspended
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States
Suspended
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
Recruiting
Kaiser Permanente-Anaheim
Anaheim, California, United States
Recruiting
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States
Suspended
PCR Oncology
Arroyo Grande, California, United States
Suspended
Sutter Auburn Faith Hospital
Auburn, California, United States
Recruiting
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Suspended
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States
Recruiting
Kaiser Permanente-Bellflower
Bellflower, California, United States
Recruiting
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Suspended
Mills-Peninsula Medical Center
Burlingame, California, United States
Suspended
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Suspended
Eden Hospital Medical Center
Castro Valley, California, United States
Suspended
John Muir Medical Center-Concord
Concord, California, United States
Active, not recruiting
Sutter Davis Hospital
Davis, California, United States
Suspended
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Active, not recruiting
Epic Care-Dublin
Dublin, California, United States
Active, not recruiting
Kaiser Permanente Dublin
Dublin, California, United States
Recruiting
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Active, not recruiting
Epic Care Partners in Cancer Care
Emeryville, California, United States
Active, not recruiting
Kaiser Permanente-Fontana
Fontana, California, United States
Recruiting
Kaiser Permanente-Fremont
Fremont, California, United States
Recruiting
Palo Alto Medical Foundation-Fremont
Fremont, California, United States
Recruiting
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, United States
Recruiting
Kaiser Permanente-Fresno
Fresno, California, United States
Recruiting
Kaiser Permanente South Bay
Harbor City, California, United States
Recruiting
Kaiser Permanente-Irvine
Irvine, California, United States
Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, United States
Recruiting
Loma Linda University Medical Center
Loma Linda, California, United States
Recruiting
Tibor Rubin VA Medical Center
Long Beach, California, United States
Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Recruiting
Kaiser Permanente West Los Angeles
Los Angeles, California, United States
Recruiting
Contra Costa Regional Medical Center
Martinez, California, United States
Active, not recruiting
Fremont - Rideout Cancer Center
Marysville, California, United States
Recruiting
Memorial Medical Center
Modesto, California, United States
Recruiting
Kaiser Permanente- Modesto MOB II
Modesto, California, United States
Recruiting
Kaiser Permanente-Modesto
Modesto, California, United States
Recruiting
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Recruiting
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Suspended
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Suspended
Bay Area Tumor Institute
Oakland, California, United States
Active, not recruiting
Kaiser Permanente Oakland-Broadway
Oakland, California, United States
Suspended

Showing 60 of 1151 sites — filter to narrow it down. 618 of the 1151 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04267848. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me