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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1210
Last updated 2026-05-22
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.
Conditions
- 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
Interventions
- OTHER
-
Observation Activity
Undergo observation
- DRUG
-
Given IV
- BIOLOGICAL
-
Given IV
- DRUG
-
Pemetrexed Disodium
Given IV
- OTHER
-
Questionnaire Administration
Ancillary studies
- DRUG
-
Given IV
- DRUG
-
Given IV
- PROCEDURE
-
Computed Tomography
Undergo CT
- PROCEDURE
-
Echocardiography Test
Undergo ECHO
- DRUG
-
Gemcitabine Hydrochloride
Given IV
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Jacob M Sands · Alliance for Clinical Trials in Oncology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-16
- Primary Completion
- 2027-01-31
- Completion
- 2027-01-31
- FDA Drug
- Yes
Countries
- United States
- Guam
Study Locations
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