15 Participants Needed

Carfilzomib + Sotorasib for Lung Cancer

Recruiting at 1 trial location
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop chemotherapy, immunotherapy, radiation therapy, KRAS inhibitors, and investigational therapies for a certain period before starting the trial. However, the protocol does not specify about other medications, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug combination Carfilzomib and Sotorasib for lung cancer?

Sotorasib has shown promising anticancer activity in patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC), with a clinically relevant response rate and duration observed in clinical trials. It is approved for use in patients with this specific mutation who have been previously treated, indicating its effectiveness in this context.12345

Is the combination of Carfilzomib and Sotorasib safe for humans?

Sotorasib, also known as Lumakras, has been approved for use in certain lung cancer patients and has a manageable safety profile, with common side effects including diarrhea, muscle pain, nausea, fatigue, liver issues, and cough. However, specific safety data for the combination of Carfilzomib and Sotorasib is not available in the provided research.23456

What makes the drug combination of Carfilzomib and Sotorasib unique for lung cancer treatment?

This drug combination is unique because it includes Sotorasib, the first approved drug specifically targeting the KRAS G12C mutation found in some lung cancers, offering a new option for patients with this specific genetic mutation.12357

What is the purpose of this trial?

This phase I trial tests the safety, side effects, and best dose of carfilzomib in combination with sotorasib in treating patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Carfilzomib is a drug that binds to and inhibits the activity of the protein complex that is responsible for degrading other damaged or unneeded proteins. The inhibition of this protein by carfilzomib can then cause tumor growth inhibition and cell death. Sotorasib is a drug that binds to and inhibits the activity of the KRAS G12C mutant. This may inhibit growth in KRAS G12C-expressing tumor cells. Combining carfilzomib and sotorasib may be a safe and effective treatment option for patients with KRAS G12C-mutated advanced or metastatic NSCLC.

Research Team

Jyoti Malhotra, M.D., M.P.H, Thoracic ...

Jyoti Malhotra, MD

Principal Investigator

City of Hope Medical Center

RS

Ravi Salgia

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adults with advanced or metastatic non-small cell lung cancer that has a specific mutation called KRAS G12C. Participants should have measurable disease and may have had prior treatments, but there are certain criteria they must meet to join.

Inclusion Criteria

Hemoglobin (Hb) β‰₯ 9 g/dL
Measurable disease by RECIST v1.1
Agreement to use effective birth control or abstain from heterosexual activity
See 14 more

Exclusion Criteria

I have HIV with a detectable viral load.
Pregnant or breastfeeding (females only)
I am currently taking antibiotics for an infection.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive carfilzomib IV and sotorasib PO in 28-day cycles

28 days per cycle, repeated until disease progression or unacceptable toxicity
6 visits (in-person) per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

Optional Biopsy

Participants may undergo optional biopsies on study

Treatment Details

Interventions

  • Carfilzomib
  • Sotorasib
Trial Overview The trial is testing the combination of two drugs, Carfilzomib and Sotorasib, to see if they're safe together, what the best dose might be, and how well they work against this type of lung cancer. It includes tests like CT scans, MRIs, biopsies, and heart checks.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (carfilzomib, sotorasib)Experimental Treatment7 Interventions
Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16 of each cycle and sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO at screening and undergo CT or MRI and collection of blood samples at screening and on study. Patients may undergo optional biopsies on study.

Carfilzomib is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Kyprolis for:
  • Multiple myeloma
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Approved in European Union as Kyprolis for:
  • Multiple myeloma
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Approved in Canada as Kyprolis for:
  • Multiple myeloma
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Approved in Japan as Kyprolis for:
  • Multiple myeloma

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Sotorasib is the first commercially available KRASG12C inhibitor, showing promise in improving outcomes for patients with KRASG12C-mutated non-small cell lung cancer (NSCLC), which is prevalent among smokers.
Despite its potential, there are ongoing questions about sotorasib's effectiveness in the brain, optimal dosing, and how it compares to standard treatments, highlighting the need for further research on resistance mechanisms and combination therapies.
An evaluation of sotorasib for the treatment of patients with non-small cell lung cancer with KRASG12C mutations.Strohbehn, GW., Sankar, K., Qin, A., et al.[2022]
In a phase 2 trial involving 126 patients with KRAS p.G12C-mutated advanced non-small-cell lung cancer (NSCLC), sotorasib demonstrated a 37.1% objective response rate, including complete responses in 3.2% of patients, indicating its efficacy in this difficult-to-treat population.
The treatment was associated with a median overall survival of 12.5 months and a median progression-free survival of 6.8 months, with manageable safety profiles, as 69.8% of patients experienced treatment-related adverse events, mostly of grade 3 severity.
Sotorasib for Lung Cancers with KRAS p.G12C Mutation.Skoulidis, F., Li, BT., Dy, GK., et al.[2022]
Sotorasib (LUMAKRASβ„’) is an innovative treatment specifically targeting KRAS G12C mutations in solid tumors, particularly effective for non-small cell lung cancer (NSCLC) and colorectal cancer.
In May 2021, sotorasib received accelerated approval from the US FDA for adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have undergone at least one prior treatment, marking a significant milestone in cancer therapy.
Sotorasib: First Approval.Blair, HA.[2022]

References

An evaluation of sotorasib for the treatment of patients with non-small cell lung cancer with KRASG12C mutations. [2022]
Sotorasib for Lung Cancers with KRAS p.G12C Mutation. [2022]
Sotorasib: First Approval. [2022]
Targeted Therapies for Previously "Undruggable" KRAS-Mutated Non-Small Cell Lung Cancer: A Review of Sotorasib and Adagrasib. [2023]
Sotorasib: A Review in KRAS G12C Mutation-Positive Non-small Cell Lung Cancer. [2022]
FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC. [2022]
Sotorasib as First-Line Treatment for Advanced KRAS G12C-Mutated Non-Small Cell Lung Carcinoma: A Case Report. [2023]
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