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NCT04613596 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
A Phase 2 study of Metastatic Non Small Cell Lung Cancer and Advanced Non-Small-Cell Lung Cancer, sponsored by Mirati Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 806
- Enrollment target
- 20
- Study locations
NCT04613596: Recruiting Phase 2 study of Metastatic Non Small Cell Lung Cancer and Advanced Non-Small-Cell Lung Cancer, sponsored by Mirati Therapeutics.
NCT04613596 is a Phase 2 study of Metastatic Non Small Cell Lung Cancer and Advanced Non-Small-Cell Lung Cancer that is actively recruiting participants, run by Mirati Therapeutics. The registered enrollment target is 806 participants, above the 356-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (126% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04613596, a Phase 2 study of Metastatic Non Small Cell Lung Cancer and Advanced Non-Small-Cell Lung Cancer, is actively recruiting participants, sponsored by Mirati Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 806 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.
Primary Outcome
Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Adagrasib
Study Locations (20)
California
- Providence - Saint Joseph Home Health - Anaheim - Anaheim
- The Oncology Institute of Hope and Innovation - Corporate Office - Cerritos
- Local Institution - 007-777 - Fountain Valley
- Local Institution - 007-778 - Laguna Hills
- Local Institution - 007-898-B - Long Beach
- MemorialCare - Long Beach Medical Center - Long Beach
- TRIO - Cancer & Blood Specialty Clinic - Los Alamitos - Los Alamitos
- Local Institution - 007-579 - Los Angeles
- Local Institution - Unk045 - Rancho Mirage
- San Francisco Veterans Affairs Medical Center - San Francisco
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
Arizona
- Local Institution - 007-556-A - Goodyear
- USOR - Arizona Oncology - Prescott Valley - Prescott Valley
- Local Institution - 007-568-A - Safford
- Local Institution - 007-568-B - Safford
- Local Institution - 007-568-C - Safford
- Local Institution - 007-568-D - Safford
- Local Institution - 007-568-E - Safford
- Arizona Clinical Research Center - Tucson
Arkansas
- Highlands Oncology Group - Springdale - Springdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 806 participants |
| Start Date | 2020-12-02 |
| Est. Completion | 2029-10-31 |
| Phase | Phase 2 |
What NCT04613596 shows while recruiting
NCT04613596 is an interventional study that assigns participants to a tested intervention. The registered 806 participants enrollment target is mid-sized for trials with a published cap, above the 356-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (126% higher).
The record links to 2 conditions, with Metastatic Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04613596 names 20 study sites across 3 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04613596 about?
NCT04613596 is a clinical study titled "Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7". The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study com...
What is the current status of trial NCT04613596?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 806 participants. The study started on 2020-12-02. Estimated completion is 2029-10-31.
What conditions does trial NCT04613596 study?
This clinical trial studies the following conditions: Metastatic Non Small Cell Lung Cancer, Advanced Non-Small-Cell Lung Cancer.
What interventions are being tested in trial NCT04613596?
The interventions under investigation include: Pembrolizumab (DRUG), Adagrasib (DRUG).
Who is sponsoring clinical trial NCT04613596?
This trial is sponsored by Mirati Therapeutics, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04613596 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04613596's enrollment target sits among peer trials
806 4th of 31 higher than 28 of 31 other Metastatic Non Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
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