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Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer (NSCLC) is a common type of lung cancer, which may often be diagnosed in later stages due to its subtle early symptoms. Some of these early symptoms may include persistent cough, shortness of breath, chest pain, fatigue, and weight loss, affecting daily life. If you have been diagnosed with non-small cell lung cancer, consider whether you might be interested in volunteering to participate in a research study. If you think you might be interested, you can learn more about this study below and complete the pre-screener if you wish.

About the NSCLC Study

The purpose of this clinical study is to investigate the safety and effectiveness of an investigational IV infusion medication (a method of delivering medication or fluids directly into a vein using a needle or syringe) in patients with Non-Small Cell Lung Cancer (NSCLC) with the KRAS G12C gene mutation. Investigational means that the study drug has not been approved, but can be used in research studies such as this.

The study drug will be administered in treatment cycles, once every 3 weeks and the duration of the study will depend on how well your cancer responds to the study drug. During each treatment cycle, you will return to the clinic for up to 14 study visits. Study procedures may include blood draws, physical exams, a tumor biopsy, and regular tumor assessments at certain visits. These assessments help evaluate the tumor’s characteristics and determine whether it has spread to other parts of the body. This process may involve MRIs and CT scans. Participants will receive trial-related procedures and study medication at no cost. You will be responsible for medical costs that are not part of the study.

Eligibility Requirements

Participants must be:

Be 18 years or older.

Be diagnosed with Non-Small Cell Lung Cancer (NSCLC) with the KRASG12C gene mutation.

Provide a sample of tumor tissue.

Have received at least 2 systemic treatments including 1 selective KRAS G12C-targeted therapy for their cancer.

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All participants will receive the investigational medication.

What to Expect

  • Step 1

    Prescreening

  • Step 2

    Study Enrollment

  • Step 3

    Trial Participation

The first step towards enrollment is to see if you pre-qualify for this study. If your medical condition and symptoms match the study criteria, you will be contacted by a study coordinator for further evaluation. If you do not qualify for this specific trial, you can submit your contact information and we will contact you if you match to new trials in the future.

After pre-qualification, the next step is to have an in-person appointment at a local study site to enroll in the research study. Study sites are medical facilities (like hospitals, clinics and universities) where study-related activities will occur. At your first visit, you will receive additional information about the trial. You may be required to complete further screening at the study site to confirm your eligibility.

Before fully enrolling in the study, participants will read and sign an informed consent document that gives a full explanation of all activities that will happen during the study. This consent document is not a contract, and participants can withdraw their consent from the study at any time.

The study drug will be administered in treatment cycles, once every 3 weeks and the duration of the study will depend on how well your cancer responds to the study drug.

To Get Started, Take the Private Online Pre-screener Questionnaire

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Frequently Asked Questions

Who is sponsoring this trial?

This trial is being run by Fortrea on behalf of the sponsor Daiichi Sankyo.

Will I receive the investigational medication/study drug if I participate in this trial?

All enrolled participants will receive the investigational IV infusion medication.

Will I receive a placebo if I participate in this trial?

No, there is no placebo in this study. A placebo looks like the investigational medication but does not contain any active ingredients.

Will I have health checks?

All participants will be monitored for adverse events and attend up to 14 visits during the study per the protocol.

What is this study about?

This study is for patients whose Non-Small Cell Lung Cancer (NSCLC) with KRAS G12C gene mutation has worsened after their last treatment. The study is investigating the safety and effectiveness of an investigational IV infusion medication (a method of delivering medication or fluids directly into a vein using a needle or syringe) in patients with NSCLC.

If I participate, can I continue my current medications?

The study doctor will review any medications you are currently taking and determine which medications can be continued, adjusted, or need to be discontinued prior to the study.

What phase of the trial is being conducted?

This is a Phase 1 clinical trial. Phase 1 trials are primarily intended to confirm safety; however, this drug has already undergone multiple clinical trials, and its safety profile has been confirmed through extensive research. Safety data will also continue to be collected in this study. The primary objective of this Phase 1 trial is to evaluate the efficacy in Non-Small Cell Lung Cancer (NSCLC) patients with the KRAS G12C gene mutation.

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