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NCT05853575 · ClinicalTrials.gov registry record · Phase 2
Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)
A Phase 2 study of Advanced Cancer and Metastatic Cancer, sponsored by Mirati Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT05853575: Recruiting Phase 2 study of Advanced Cancer and Metastatic Cancer, sponsored by Mirati Therapeutics.
NCT05853575 is a Phase 2 study of Advanced Cancer and Metastatic Cancer that is actively recruiting participants, run by Mirati Therapeutics. The registered enrollment target is 200 participants, below the 245-participant average among 122 other Advanced Cancer trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 19 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05853575, a Phase 2 study of Advanced Cancer and Metastatic Cancer, is actively recruiting participants, sponsored by Mirati Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.
Primary Outcome
ORR evaluation of subjects treated with adagrasib 600 mg BID without regard to food versus 400 mg BID with food having NSCLC with KRAS G12C mutation (Study Population) will be completed per blinded independent central radiology (BICR) review. Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of adagrasib until last dose of adagrasib.
Conditions Studied
Interventions
- DRUG Adagrasib
Study Locations (20)
Other
- A.C. Camargo Cancer Center - São Paulo
- A.C. Camargo Cancer Center - São Paulo
California
- Local Institution - 101 - Santa Rosa
Illinois
- Local Institution - 104 - Chicago
Minnesota
- Local Institution - 103 - Minneapolis
Missouri
- Kansas City VA Hospital - Kansas City
North Carolina
- Veterans Affairs Medical Center (VAMC) - Durham - Oncology - Durham
Texas
- VA North Texas Healthcare System/Dallas VA Medical Center - Dallas
Estado de Bahia
- Ensino e Terapia de Inovação Clinica AMO-ÉTICA / Ética Pesquisa e Ensino - Salvador
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-02-16 |
| Est. Completion | 2026-07-30 |
| Phase | Phase 2 |
What NCT05853575 shows while recruiting
NCT05853575 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 245-participant average among 122 other Advanced Cancer trials with a reported enrollment target (18% lower).
The record links to 3 conditions, with Advanced Cancer appearing as the primary indexed condition, and to 1 intervention - of which Adagrasib is the first listed.
NCT05853575 names 20 study sites across 19 states, led by Other, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05853575 about?
NCT05853575 is a clinical study titled "Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)". This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.
What is the current status of trial NCT05853575?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2024-02-16. Estimated completion is 2026-07-30.
What conditions does trial NCT05853575 study?
This clinical trial studies the following conditions: Advanced Cancer, Metastatic Cancer, Malignant Neoplasm of Lung.
What interventions are being tested in trial NCT05853575?
The interventions under investigation include: Adagrasib (DRUG).
Who is sponsoring clinical trial NCT05853575?
This trial is sponsored by Mirati Therapeutics, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05853575 being conducted?
This trial has 20 study locations across California, Illinois, Minnesota, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05853575's enrollment target sits among peer trials
200 30th of 122 higher than 90 of 122 other Advanced Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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