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NCT04933695 · ClinicalTrials.gov registry record · Phase 2
A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT04933695 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 42 participants.
The verdict
NCT04933695, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) \< 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 \< 1% and in a subgroup of participants with STK11 co-mutation.
Interventions
- DRUG Sotorasib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-01-28 |
| Est. Completion | 2025-05-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04933695
The ClinicalTrials.gov registry entry for NCT04933695 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sotorasib is the first listed.
NCT04933695 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04933695 about?
NCT04933695 is a clinical study titled "A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment". The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor...
What is the current status of trial NCT04933695?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2022-01-28. Estimated completion is 2025-05-27.
What interventions are being tested in trial NCT04933695?
The interventions under investigation include: Sotorasib (DRUG).
Who is sponsoring clinical trial NCT04933695?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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