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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a combination of a vaccine called CIMAvax-EGF and a KRAS G12C inhibitor (either sotorasib or adagrasib) to treat advanced non-small cell lung cancer. The researchers aim to determine if this combination can help the immune system fight cancer by blocking signals that promote cancer cell growth. Individuals with non-small cell lung cancer featuring a specific mutation called KRAS G12C, especially those experiencing disease progression, might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to potentially benefit from an innovative therapy.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have received anticancer chemotherapy within 4 weeks before starting the study drug, and certain conditions apply if you are on corticosteroids or have had recent surgery.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CIMAvax-EGF is generally safe for patients, having been tested in over 5,000 people with non-small cell lung cancer (NSCLC). The most common side effects are mild, including reactions at the injection site, fever, and chills, and are usually easy to manage.

Studies indicate that adagrasib is well tolerated in patients with a specific type of NSCLC called KRAS G12C mutation. While most side effects are mild, some patients needed to adjust their dose due to these effects. Recent research has not identified any new safety concerns.

Sotorasib is considered safe and has received FDA approval for treating advanced NSCLC with KRAS G12C mutations. Studies have shown it has a manageable safety profile, with no new safety issues reported. Common side effects include liver-related problems, which are generally controllable.

Overall, these treatments appear safe based on available studies, though each may have mild side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination treatment of CIMAvax-EGF with KRAS G12C inhibitors like adagrasib or sotorasib for non-small cell lung cancer because it targets a specific mutation that many standard therapies do not directly address. CIMAvax-EGF is an active immunotherapy that stimulates the body's immune response against cancer cells by targeting the epidermal growth factor (EGF). Meanwhile, KRAS G12C inhibitors specifically target a genetic mutation in cancer cells that is notoriously difficult to treat. This dual approach not only aims to enhance the immune system's response but also directly inhibits a key driver of tumor growth, offering a potentially more effective treatment strategy compared to conventional chemotherapies or radiation.

What evidence suggests that this trial's treatments could be effective for advanced non-small cell lung cancer?

Research has shown that CIMAvax-EGF can aid individuals with advanced non-small cell lung cancer (NSCLC) by enhancing the immune system's ability to combat cancer cells. Studies found that patients using CIMAvax-EGF had a 3-year survival rate of up to 29%, and it is considered safe. In this trial, participants will receive CIMAvax-EGF combined with a KRAS G12C inhibitor.

Adagrasib, one of the KRAS G12C inhibitors studied in this trial, has shown promise in treating this lung cancer. It increased the time patients lived without cancer progression from 3.8 months to 5.5 months.

Sotorasib, another KRAS G12C inhibitor under investigation in this trial, demonstrated cancer-fighting effects, with a 2-year survival rate of 32.5% in patients who had previous treatments for NSCLC. It also caused tumor shrinkage in 37% of patients.23678

Who Is on the Research Team?

GK

Grace K Dy

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced non-small cell lung cancer that has a KRAS G12C mutation. Participants need to have good organ function, be able to care for themselves most of the time, and have at least a 6-month life expectancy.

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
See 7 more

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

Trial Overview

The study is testing whether combining CIMAvax-EGF vaccine with a KRAS G12C inhibitor (either sotorasib or adagrasib) works better for treating advanced lung cancer with this specific mutation. Patients are monitored using scans and lab tests.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (CIMAvax-EGF and KRAS G12C inhibitor)Experimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+

Citations

Adagrasib in Non–Small-Cell Lung Cancer Harboring a ...

As of October 15, 2021, a total of 116 patients with KRASG12C-mutated NSCLC had been treated (median follow-up, 12.9 months); 98.3% had ...

KRAS G12C Inhibitor Outcomes in Advanced Non-Small ...

Among KRAS G12C NSCLC patients, a never or light smoking history of less than 10 pack-year is associated with worse clinical outcomes on KRAS ...

Adagrasib Plus Pembro Beneficial in KRAS G12C-Mutated ...

Disease-free survival was significantly reduced in those who did not receive ADT (HR, 0.56; 95% CI, 0.38–0.83); however, the reduction in those ...

Adagrasib for KRAS G12C mutated advanced non-small- ...

The primary outcome was progression-free survival, which improved from a median of 3·8 months for patients receiving docetaxel to 5·5 months for ...

Advances in the treatment of KRAS G12C mutant non–small ...

In summary, adagrasib demonstrated improvement in both PFS and ORR compared to docetaxel in patients with previously treated KRAS G12C NSCLC.

An updated overview of K-RAS G12C inhibitors in advanced ...

Clinical trials have shown that KRAS G12C inhibitors improved objective response rates and progression-free survival compared with standard treatments. These ...

KRAS G12C | KRAZATI® (adagrasib) for NSCLC

Learn more about the KRAS G12C mutation in NSCLC and why advanced treatment may be appropriate. Please see indications and important safety information.

mutated non-small-cell lung cancer (KRYSTAL-12): a ...

Adagrasib demonstrated a statistically significant improvement in progression-free survival over docetaxel in patients with previously treated ...