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NCT07012031 · ClinicalTrials.gov registry record · Phase 1
Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation
A Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 4
- Study locations
NCT07012031 is a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (62% lower). The trial reports 4 study locations across 1 state.
The verdict
NCT07012031, a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase I/II trial tests the safety, side effects and best dose of sotorasib with trastuzumab deruxtecan and how well the combination works in treating patients with KRAS G12C mutated non-small cell lung cancer that has spread to nearby tissues or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Sotorasib blocks a protein made by the mutated KRAS gene (KRAS p.G12C), which may help keep tumor cells from growing and may kill them. It is a type of targeted therapy. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving sotorasib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or effective in treating patients with locally advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- PROCEDURE Echocardiography Test
Study Locations (4)
Florida
- Moffitt Cancer Center-International Plaza - Tampa
- Moffitt Cancer Center - McKinley Campus - Tampa
- Moffitt Cancer Center - Tampa
- Moffitt Cancer Center at Wesley Chapel - Wesley Chapel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2026-08-07 |
| Est. Completion | 2027-06-14 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07012031
The ClinicalTrials.gov registry entry for NCT07012031 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (62% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07012031 reports 4 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT07012031 about?
NCT07012031 is a clinical study titled "Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation". This phase I/II trial tests the safety, side effects and best dose of sotorasib with trastuzumab deruxtecan and how well the combination works in treating patients with KRAS G12C mutated non-small cell lung cancer that has spread to nearby tissues or lymph nodes (locally advanced) or that has spread...
What is the current status of trial NCT07012031?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2026-08-07. Estimated completion is 2027-06-14.
What conditions does trial NCT07012031 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Locally Advanced Lung Non-Small Cell Carcinoma.
What interventions are being tested in trial NCT07012031?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE).
Who is sponsoring clinical trial NCT07012031?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07012031 being conducted?
This trial has 4 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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