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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: Recruiting Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Will be defined as an adverse event (AE) that is at least possibly related to the study treatment. Severity will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

Conditions Studied

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

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

FieldValue
Enrollment Target 37 participants
Start Date 2026-08-07
Est. Completion 2027-06-14
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What NCT07012031 shows while recruiting

NCT07012031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (62% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Stage IV Lung Cancer AJCC v8

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 NCT07012031's enrollment target sits among peer trials

37 41st of 81 higher than 40 of 81 other Stage IV Lung Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07012031

Source: ClinicalTrials.gov NCT07012031, the US trial registry maintained by the National Library of Medicine. NCT07012031 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.