1200 Participants Needed

Sotorasib for Solid Cancers

Recruiting at 103 trial locations
AC
Overseen ByAmgen Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a medication called sotorasib. It is aimed at adults who have advanced solid tumors with a specific genetic mutation known as KRAS p.G12C. Sotorasib works by blocking this mutation, which can help slow down or stop the growth of the cancer. Sotorasib is the first targeted agent approved for this specific mutation in patients who have previously received treatment.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is sotorasib safe for humans?

Sotorasib has been shown to have a manageable safety profile in clinical trials, with common side effects including diarrhea, muscle pain, nausea, fatigue, liver issues, and cough. It is important to discuss potential risks and benefits with a healthcare provider.12345

What makes the drug Sotorasib unique for treating solid cancers?

Sotorasib is unique because it is the first drug specifically targeting the KRAS G12C mutation, which is common in certain solid tumors like non-small cell lung cancer. It works by binding irreversibly to the mutated protein, blocking signals that promote cancer cell growth, and is taken orally, making it more convenient than some other treatments.12367

What data supports the effectiveness of the drug Sotorasib for solid cancers?

Sotorasib has shown promising results in treating non-small cell lung cancer (NSCLC) with KRAS G12C mutations, with a significant number of patients responding to the treatment and experiencing a median progression-free survival of almost 7 months. It has been approved for use in patients with this specific mutation who have already tried other treatments.12389

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced solid tumors that have a specific mutation called KRAS p.G12C. Participants must have their condition confirmed by certain lab tests. People with primary brain tumors, recent heart attacks, or issues that prevent taking oral meds can't join.

Inclusion Criteria

My cancer is advanced or has spread, and tests show a KRAS mutation.

Exclusion Criteria

I have a primary brain tumor.
I have not had a heart attack in the last 6 months.
I do not have active brain issues related to my cancer.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Exploration

Participants receive sotorasib in combination with other therapies to determine the optimal dose

12 months

Dose Expansion

Participants continue to receive the determined dose to further evaluate safety and efficacy

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Sotorasib
Trial Overview The trial is testing the safety of sotorasib in combination with various cancer treatments like chemotherapy and targeted drugs (atezolizumab, carboplatin, etc.) in patients with a particular genetic change in their tumor cells.
How Is the Trial Designed?
14Treatment groups
Experimental Treatment
Group I: Sotorasib MonotherapyExperimental Treatment1 Intervention
Group II: Sotorasib + trametinib + panitumumabExperimental Treatment3 Interventions
Group III: Sotorasib + pembrolizumabExperimental Treatment2 Interventions
Group IV: Sotorasib + panitumumab +/- chemotherapyExperimental Treatment3 Interventions
Group V: Sotorasib + palbociclibExperimental Treatment2 Interventions
Group VI: Sotorasib + everolimusExperimental Treatment2 Interventions
Group VII: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumabExperimental Treatment3 Interventions
Group VIII: Sotorasib + atezolizumabExperimental Treatment2 Interventions
Group IX: Sotorasib + afatinibExperimental Treatment2 Interventions
Group X: Sotorasib + TNO155Experimental Treatment2 Interventions
Group XI: Sotorasib + RMC-4630Experimental Treatment2 Interventions
Group XII: Sotorasib + MVASI® (bevacizumab-awwb)+ ChemotherapyExperimental Treatment4 Interventions
Group XIII: Sotorasib + BI 1701963Experimental Treatment2 Interventions
Group XIV: Sotorasib + AMG 404Experimental Treatment2 Interventions

Sotorasib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Lumakras for:
🇪🇺
Approved in European Union as Lumakras for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

Sotorasib (LUMAKRAS™) 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]
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 is a first-in-class oral medication that specifically targets the KRAS G12C mutation in non-small cell lung cancer (NSCLC), showing a clinically relevant objective response rate in patients during the CodeBreaK 100 trial.
The drug has a manageable safety profile, allowing for dose adjustments to handle any side effects, making it a valuable treatment option for patients with advanced KRAS G12C mutation-positive NSCLC who have already undergone other therapies.
Sotorasib: A Review in KRAS G12C Mutation-Positive Non-small Cell Lung Cancer.Lee, A.[2022]

Citations

Sotorasib: First Approval. [2022]
Sotorasib for Lung Cancers with KRAS p.G12C Mutation. [2022]
Sotorasib: A Review in KRAS G12C Mutation-Positive Non-small Cell Lung Cancer. [2022]
An evaluation of sotorasib for the treatment of patients with non-small cell lung cancer with KRASG12C mutations. [2022]
Sotorasib Edges Closer to Approval. [2021]
FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC. [2022]
Targeted Therapies for Previously "Undruggable" KRAS-Mutated Non-Small Cell Lung Cancer: A Review of Sotorasib and Adagrasib. [2023]
Remarkable Intracranial Response to Sotorasib in a Patient With KRAS G12C-Mutated Lung Adenocarcinoma and Untreated Brain Metastases: A Case Report. [2022]
Rapid Response to Sotorasib of a Patient With KRAS G12C-Mutated Lung Cancer With Cancer-Associated Disseminated Intravascular Coagulation: A Case Report. [2023]
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