CIMAvax-EGF + KRAS G12C Inhibitor for Non-Small Cell Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Must be taking: KRAS G12C inhibitors

Must not be taking: Systemic corticosteroids

Disqualifiers: Active infections, Brain metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 20

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Grace K Dy

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

* Plasma creatinine ≤ 1.5 x institution upper limit of normal (ULN)

* Have at least 6-month life expectancy

* Platelets ≥ 70 x 10\^9/L

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Loading Phase

Patients receive CIMAvax-EGF intramuscularly every 2 weeks for 4 doses

8 weeks

4 visits (in-person)

Maintenance Phase

Patients receive CIMAvax-EGF every 4 weeks for a total of 1 year, with potential adjustments based on antibody titer levels

12 months

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

4 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Adagrasib
• CIMAvax-EGF
• Sotorasib

How Is the Trial Designed?

Group I: Treatment (CIMAvax-EGF and KRAS G12C inhibitor) Experimental Treatment 6 Interventions

LOADING PHASE: Patients receive CIMAvax-EGF IM every 2 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive CIMAvax-EGF IM every 4 weeks for a total of 1 year of treatment, in the absence of disease progression or unacceptable toxicity. Patients who remain on study beyond 12 months and with antibody titer ≥ 1:4000 at the end of the loading phase may receive CIMAvax-EGF IM every 2 months as long as titer levels continue to be maintained \> 1:4000. After the first 6 months of alternate dosing, may receive CIMAvax-EGF IM every 3 months in the absence of disease progression or unacceptable toxicity. Patients also receive sotorasib PO QD or adagrasib PO BID per their physician choice on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI at baseline and as clinically indicated and undergo CT scan and blood sample collection throughout the study.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+