RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Sotorasib for Locally Advanced Lung Non-Small Cell Carcinoma

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.

Official registry: https://clinicaltrials.gov/study/NCT07012031 · National Cancer Institute (NCI) · enrollment listed as 37

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Computed Tomography. The registry lists allocation as na. 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).

They plan to enroll about 37 people at 9 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of Sotorasib Plus Trastuzumab Deruxtecan in Patients With Advanced Non-Small Cell Lung Cancer With a KRASG12C Mutation

Interventions: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Echocardiography Test, Magnetic Resonance Imaging, Multigated Acquisition Scan, Sotorasib, Trastuzumab Deruxtecan

Primary outcome (registry wording): Dose-limiting toxicities of combined trastuzumab deruxtecan (DS-8201a) and sotorasib (AMG-510) treatment (Phase I)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Data must be available for which prior KRAS\^G12C inhibitor treatment the patient has received and the dates that they received it (type of KRAS\^G12C inhibitor used and start and end dates must be collected prior to enrollment)
Because no dosing or adverse event data are currently available on the use of sotorasib (AMG-510) in combination with trastuzumab deruxtecan (DS-8201a) in patients \< 18 years of age, children are excluded from this study
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Hemoglobin ≥ 9 g/dL (within 14 days of enrollment)
Leukocytes ≥ 3,000/mcL (within 14 days of enrollment)
Absolute neutrophil count ≥ 1,500/mcL (within 14 days of enrollment)
No administration of granulocyte colony stimulating factor (G-CSF) is allowed within 1 week prior to screening assessment

Who the registry excludes

Patients who have had chest radiation therapy within 4 weeks (2 weeks for palliative stereotactic body radiation therapy). These patients will be excluded because trastuzumab deruxtecan (DS-8201a) and sotorasib (AMG-510) are known to increase the risk of developing pneumonitis
Patients who have had a major surgery and are not yet fully healed from surgical incisions
Patients who have had prior treatment with an antibody drug conjugate with a topoisomerase 1 inhibitor payload (i.e., sacituzumab govitecan, datopotomab deruxtecan, or trastuzumab deruxtecan) or with a topoisomerase inhibitor
Patients with a history of significant lung disease requiring systemic corticosteroids treatment (\> 10 mg of prednisone daily) within the last six months of registration
Based on pre-clinical data, trastuzumab deruxtecan (DS-8201a) is associated with corneal disease. Patients with clinically significant corneal disease, in the opinion of the investigator, will be excluded from this study
Patients with spinal cord compression, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms
Patients with an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

9 listed

University of California Davis Comprehensive Cancer Center — Sacramento, California (recruiting)
Moffitt Cancer Center-International Plaza — Tampa, Florida (recruiting)
Moffitt Cancer Center - McKinley Campus — Tampa, Florida (recruiting)
Moffitt Cancer Center — Tampa, Florida (recruiting)
Moffitt Cancer Center at Wesley Chapel — Wesley Chapel, Florida (recruiting)
Case Western Reserve University — Cleveland, Ohio (recruiting)
Ohio State University Comprehensive Cancer Center — Columbus, Ohio (recruiting)
UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania (recruiting)
University of Virginia Cancer Center — Charlottesville, Virginia (recruiting)

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FAQ about this NCT record

Is NCT07012031 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07012031?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07012031?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary