Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer ALCHEMIST Chemo-IO Study
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- STATUS
- Recruiting
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- participants needed
- 1263
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- sponsor
- National Cancer Institute (NCI)
Summary
This phase III ALCHEMIST trial compares the addition of
Description
PRIMARY OBJECTIVES:
I. To compare the disease free survival (DFS) and overall survival (OS) (dual primary
endpoints) between combination
II. To compare the DFS and OS (dual primary endpoints) between sequential
SECONDARY OBJECTIVES:
I. To compare the DFS and OS between combination
II. To compare the adverse event rates and drug discontinuation rates due to adverse events
with the addition of
III. To compare the DFS and OS between
IV. To compare the DFS and OS between
QUALITY OF LIFE OBJECTIVES:
I. To compare patient-reported quality of life (QOL) one year after randomization as assessed
by the European Organization for the Research and Treatment of
II. To compare patient reported QOL one year after randomization as assessed by EORTC QLQ-C30
between patients randomized to receive
III. To compare patient-reported QOL at completion of
IV. To present longitudinal trajectories by arm of patient-reported
CORRELATIVE SCIENCE OBJECTIVES:
I. To compare the DFS and OS with the addition of
II. To compare the DFS and OS with the addition of
III. To identify a
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM A:
INITIAL THERAPY: Patients receive 1 of 4
CONTINUANCE THERAPY: Patients then undergo observation.
ARM B:
INITIAL THERAPY: Patients receive 1 of 4
CONTINUANCE THERAPY: Patients then receive
ARM C:
INITIAL THERAPY: Patients receive 1 of 4
CONTINUANCE THERAPY: Patients then receive
*ACCEPTABLE REGIMENS: DOUBLET I: Patients receive
DOUBLET II: Patients receive
DOUBLET III: Patients receive
DOUBLET IV: Patients receive
After completion of study treatment, patients are followed up at 6 weeks, then every 3 months for 2 years from randomization, every 6 months for years 2-4, and then annually for up to 10 years from randomization.
Details
Condition |
Lung Non-Small Cell Carcinoma, Stage IB |
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Age | 18years - 100years |
Clinical Study Identifier | NCT04267848 |
Sponsor | National |
Last Modified on | 19 February 2024 |
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Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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