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Clinical Trials in Mexico / NCT04267848
Recruiting Phase 3

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])

NCT04267848 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2020-06-16
Last updated
2026-10-01

Condition(s) studied

Lung Non-Small Cell CarcinomaLung Non-Small Cell Squamous CarcinomaLung Non-Squamous Non-Small Cell CarcinomaStage II Lung Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8

Investigational drug(s) / intervention(s)

Biospecimen CollectionCarboplatin →Cisplatin →Computed TomographyEchocardiography TestGemcitabine Hydrochloride →Magnetic Resonance ImagingObservation ActivityPaclitaxel →Pembrolizumab →Pemetrexed Disodium →Questionnaire Administration

Biospecimen Collection: Undergo blood sample collection

Carboplatin: Given IV

Cisplatin: Given IV

Computed Tomography: Undergo CT

Echocardiography Test: Undergo ECHO

Gemcitabine Hydrochloride: Given IV

Magnetic Resonance Imaging: Undergo MRI

Observation Activity: Undergo observation

Paclitaxel: Given IV

Pembrolizumab: Given IV

Pemetrexed Disodium: Given IV

Questionnaire Administration: Ancillary studies

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (1151)

FacilityCityRegionStatus
Anchorage Associates in Radiation Medicine Anchorage Alaska Suspended
Anchorage Radiation Therapy Center Anchorage Alaska Suspended
Alaska Breast Care and Surgery LLC Anchorage Alaska Suspended
Alaska Oncology and Hematology LLC Anchorage Alaska Suspended
Alaska Women's Cancer Care Anchorage Alaska Suspended
Anchorage Oncology Centre Anchorage Alaska Suspended
Katmai Oncology Group Anchorage Alaska Suspended
Providence Alaska Medical Center Anchorage Alaska Suspended
Fairbanks Memorial Hospital Fairbanks Alaska Recruiting
Banner MD Anderson Cancer Center Gilbert Arizona Suspended
Kingman Regional Medical Center Kingman Arizona Suspended
Cancer Center at Saint Joseph's Phoenix Arizona Suspended
Banner Boswell Medical Center Sun City Arizona Recruiting
Banner University Medical Center - Tucson Tucson Arizona Active Not Recruiting
University of Arizona Cancer Center-North Campus Tucson Arizona Active Not Recruiting
Mercy Hospital Fort Smith Fort Smith Arkansas Suspended
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas Suspended
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas Recruiting
Kaiser Permanente-Anaheim Anaheim California Recruiting
Kaiser Permanente-Deer Valley Medical Center Antioch California Recruiting
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California Suspended
PCR Oncology Arroyo Grande California Suspended
Sutter Auburn Faith Hospital Auburn California Recruiting
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California Suspended
Kaiser Permanente-Baldwin Park Baldwin Park California Recruiting
Kaiser Permanente-Bellflower Bellflower California Recruiting
Alta Bates Summit Medical Center-Herrick Campus Berkeley California Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California Suspended
Mills-Peninsula Medical Center Burlingame California Suspended
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California Suspended
Eden Hospital Medical Center Castro Valley California Suspended
John Muir Medical Center-Concord Concord California Active Not Recruiting
Sutter Davis Hospital Davis California Suspended
City of Hope Comprehensive Cancer Center Duarte California Active Not Recruiting
Epic Care-Dublin Dublin California Active Not Recruiting
Kaiser Permanente Dublin Dublin California Recruiting
Bay Area Breast Surgeons Inc Emeryville California Active Not Recruiting
Epic Care Partners in Cancer Care Emeryville California Active Not Recruiting
Kaiser Permanente-Fontana Fontana California Recruiting
Kaiser Permanente-Fremont Fremont California Recruiting

+ 1111 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More National Cancer Institute (NCI) trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04267848 on ClinicalTrials.gov ↗ ← All trials in Mexico