This phase II trial tests how well giving CIMAvax-EGF with KRAS G12C inhibitor (sotorasib or adagrasib) for the treatment of patients with KRAS G12C mutated non small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Vaccines, such as CIMAvax-EGF, made from specific peptides or antigens may help the body build an effective immune response to kill tumor cells. Sotorasib and adagrasibare in a class of medications called kinase inhibitors. They work by blocking the signals that cause tumor cells to multiply. This helps to stop the spread of tumor cells. Giving CIMAvax-EGF with a KRAS G12C inhibitor may be effective for treating advanced, KRAS G12C mutated non small cell lung cancer.
Age ≥ 18 years old
Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at the time of study treatment initiation
Have pathologically (cytology or histology) confirmed diagnosis of NSCLC. Non-small cell carcinoma diagnosis without specific tissue of origin confirmation may be eligible with approval from primary investigator (PI) review
Must be eligible for treatment with standard of care KRAS G12C inhibitors
Receipt of anticancer chemotherapy within 4 weeks before the first administration of study drug (see exception allowed for #2)
Previously treated with KRAS G12C inhibitor (exception allowed for patients who started KRAS G12C inhibitor within 4 weeks of study enrollment)
Prior radiotherapy or gamma knife within 2 weeks of study treatment for non-brain metastasis. Subjects must have recovered from all radiation related toxicities
Active/untreated brain metastasis. Whole brain radiation or gamma knife radiosurgery performed less than 2 weeks prior to first administration of study drug. Previously treated brain metastasis allowed as long as not requiring steroids
Single group
Adagrasib
DrugGiven PO
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT scan
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine
Biological/VaccineGiven IM
Sotorasib
DrugGiven PO
Progression free survival (PFS)
Will be calculated as the binomial proportion of patients who have not experienced a PFS event within 12 months of study enrollment. The 95% confidence intervals for 12-month PFS will be estimated using Jeffreys method.
Dose limiting toxicity (Safety lead in)
Objective response rate (ORR)
Will be based on Response Evaluation Criteria in Solid Tumors. Will be calculated as the number of patients with a confirmed complete or partial response divided by the total number of patients. The 95% confidence intervals for ORR will be estimated using Jeffreys method.
Progression free survival (PFS)
Will also be presented using Kaplan-Meier product limit estimators.
Median PFS
Will also be presented using Kaplan-Meier product limit estimators.
Overall survival
Will also be presented using Kaplan-Meier product limit estimators.
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