OncoMatch/Clinical Trials/NCT07012031
Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation
Is NCT07012031 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Trastuzumab Deruxtecan and Sotorasib for locally advanced lung non-small cell carcinoma.
Treatment: Sotorasib · Trastuzumab Deruxtecan — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: KRAS G12C mutation
KRAS^G12C-mutant NSCLC
Required: HER2 (ERBB2) mutation
Patients must also have ERBB2 (HER2) mutations status identified by tumor tissue or plasma ctDNA profiling; local (i.e., commercial or institutional next generation sequencing [NGS]) molecular testing will be allowed.
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: KRAS inhibitor
previously been treated with a KRAS^G12C inhibitor
Must have received: immune checkpoint inhibitor
previously been treated with ... an immune checkpoint inhibitor (ICI)
Must have received: chemotherapy
previously been treated with ... chemotherapy
Cannot have received: antibody-drug conjugate with a topoisomerase 1 inhibitor payload (sacituzumab govitecan, datopotomab deruxtecan, trastuzumab deruxtecan)
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
Cannot have received: topoisomerase inhibitor
prior treatment with ... a topoisomerase inhibitor
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dL; leukocytes ≥ 3,000/mcL; ANC ≥ 1,500/mcL; platelets ≥ 100,000/mcL; no G-CSF within 1 week prior to screening; no transfusions with red blood cells or platelets within 1 week prior to screening
Kidney function
Creatinine ≤ 1.5 x institutional ULN OR creatinine clearance (CrCL) ≥ 30 mL/min
Liver function
Total bilirubin ≤ 1.5 x institutional ULN (or < 3 x ULN in presence of Gilbert's syndrome or liver metastases); AST/ALT ≤ 3 x ULN (or < 5 x ULN with liver metastases)
Cardiac function
LVEF ≥ 50% by ECHO or MUGA within 28 days before enrollment; QTc ≤ 470 msec for women and ≤ 450 msec for men
Hemoglobin ≥ 9 g/dL ... Platelets ≥ 100,000/mcL ... Total bilirubin ≤ 1.5 x institutional ULN ... AST/ALT ≤ 3 x institutional ULN ... Creatinine ≤ 1.5 x institutional ULN OR CrCL ≥ 30 mL/min ... LVEF ≥ 50% ... QTc ≤ 470 msec for women and ≤ 450 msec for men
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center-International Plaza · Tampa, Florida
- Moffitt Cancer Center - McKinley Campus · Tampa, Florida
- Moffitt Cancer Center · Tampa, Florida
- Moffitt Cancer Center at Wesley Chapel · Wesley Chapel, Florida
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