CIMAvax-EGF with KRAS G12C Inhibitor for Advanced Lung Cancer
This study is testing a combination of treatments for advanced non-small cell lung cancer (NSCLC) that has a specific change in the KRAS gene, called KRAS G12C. You would receive CIMAvax-EGF, a vaccine that may help your body's immune system fight cancer, along with a KRAS G12C inhibitor like Adagrasib. These inhibitors block signals that help cancer cells grow. Researchers want to see how long people live without their cancer growing (progression-free survival) and if the treatment is safe. To join, you must be at least 18 years old, have advanced NSCLC with the KRAS G12C mutation, and meet other health criteria. The study plans to enroll 29 participants.
- Study design
- This is an interventional study, meaning you will receive a specific treatment. It plans to enroll 29 participants.
- What's involved
- You would receive CIMAvax-EGF injections every 2-4 weeks for at least a year, and take Adagrasib pills daily. You will also have blood samples collected, CT scans, and MRI scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will track how long you live without your cancer growing or until death, for up to 12 months. They will also monitor for side effects for up to 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07543172
CIMAvax-EGF With KRAS G12C Inhibitor for the Treatment of Advanced, KRAS G12C Mutated Non Small Cell Lung Cancer
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentRoswell Park Cancer InstituteInvestigator-initiated
~29 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:AdagrasibBiospecimen CollectionComputed TomographyMagnetic Resonance ImagingRecombinant Human EGF-rP64K/Montanide ISA 51 VaccineSotorasib
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS)
Measured over From enrollment to the loading phase and documentation of disease progression or death, at 12 months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Grace K Dy · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Documented KRAS G12C mutation. Testing will occur by standard of care next generation sequencing (NGS) testing and results will be available in the medical record
Have at least 6-month life expectancy
Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L
Platelets ≥ 70 x 10\^9/L
Hemoglobin ≥ 9 g/dL
Plasma creatinine ≤ 1.5 x institution upper limit of normal (ULN)
ALT (alanine aminotransferase) and aspartate aminotransferase (AST) ≤ 3 x ULN (ALT and AST ≤ 5 x ULN is acceptable if liver metastases are present)
Total plasma bilirubin ≤ 1.5 x ULN. For patients with well documented Gilbert's syndrome, total bilirubin ≤ 3 x ULN with direct bilirubin within normal range
Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Participant agrees to provide blood samples at the start of treatment and at multiple times during the study as well as research specimen allocation at the time of standard of care rebiopsy at the time of disease progression
Exclusion
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
Leptomeningeal involvement regardless of treatment status
Active, clinically serious infections or other serious uncontrolled medical conditions (exception allowed: patients taking prophylactic anti-viral, anti-fungal or antibiotics. Patients on long-term treatment for acid-fast or fungal organisms must have been on stable dosing of ant-infective regimen for at least 4 weeks of uninterrupted treatment and without associated common toxicity criteria (CTC) grade 2 or higher drug-related lab abnormalities within 4 weeks of study enrollment)
Had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery
Currently receiving or has received systemic corticosteroids within 4 weeks prior to starting study drug for management of brain metastases, or who have not fully recovered from side effects of such treatment. Steroids for endocrine replacement or receipt of short course of steroids during this preceding 4-week period as supportive medication such as for drug allergy, anti-emetic, etc. is allowed
Pregnant or nursing female participants
Patients diagnosed with a secondary invasive cancer within 2 years prior to starting protocol therapy with the following exceptions: non-melanoma skin cancers, in-situ cancers, and prostate cancer Gleason ≤ to 6 (under surveillance or treated), early-stage node-negative estrogen receptor (ER) +/ progesterone receptor (PR) + breast cancer with Oncotype Dx score \< 25 (adjuvant hormonal therapy allowed)
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to:
Myocardial infarction or arterial thromboembolic events within 30 days prior to enrollment or with severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease
Patient has known hypersensitivity to the components of the study drugs or any analogs
What this trial measures
- Progression free survival (PFS)From enrollment to the loading phase and documentation of disease progression or death, at 12 months
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)Up to 3 years