OncRef

Clinical Trial: NCT04267848

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])

Status:

RECRUITING

Phase:

Phase 3

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-20

Study Overview

Brief 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.

Official Title

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

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

Intervention / Treatment

  • Procedure: Biospecimen Collection
  • Drug: Carboplatin
  • Drug: Cisplatin
  • Procedure: Computed Tomography
  • Procedure: Echocardiography Test
  • Drug: Gemcitabine Hydrochloride
  • Procedure: Magnetic Resonance Imaging
  • Other: Observation Activity
  • Drug: Paclitaxel
  • Biological: Pembrolizumab
  • Drug: Pemetrexed Disodium
  • Other: Questionnaire Administration

Other Study ID Numbers

  • NCI-2020-00751
  • NCI-2020-00751
  • A081801
  • A081801
  • U10CA180821

Start Date (Actual)

2020-06-16

Primary Completion Date (Estimated)

2030-01-31

Study Completion Date (Estimated)

2030-01-31

Enrollment (Estimated)

1210

Study Type

Interventional

Phase

Phase 3