Phase 1 Lung Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with non-small cell lung cancer (confirmed by a tissue or cell sample) that is locally advanced, cannot be removed by surgery, or has spread to other parts of the body, and who have not yet received treatment for this stage of the disease.
• People who have a tumor that can be safely biopsied (a small sample taken from the tumor), and who are willing to have a biopsy before and during treatment if the treating doctor judges it to be safe.
• People whose cancer can be measured on scans according to standard medical criteria (called RECIST v1.1).
• People whose tumor has one of the following specific gene changes (mutations): KRAS G12C, G12V, G12D, G12A, G13D, or G12R, confirmed by an approved genetic test.
• People who are in generally good health and able to carry out daily activities with no or minimal limitations (rated 0 or 1 on a standard medical scale called ECOG).
• People whose blood counts and organ function (including white blood cells, platelets, red blood cells, liver, and kidneys) meet minimum levels as measured by blood tests.
• Women who could become pregnant must have a negative pregnancy blood test before joining.
• Women who could become pregnant must agree to use contraception during treatment and for 5 months after treatment ends.
• Men who are sexually active with women who could become pregnant must agree to use contraception during treatment and for 7 months after treatment ends.
• All sexually active participants (male and female) must use at least one barrier method of contraception (such as a condom), regardless of any other contraception used.
• People who are willing and able to read and sign a consent form agreeing to take part.

Who may not be able to join:

• People who are expected to need any other cancer treatment (systemic or local) at the same time as the study.
• People who have received high-dose steroid medications (above the equivalent of 10 mg/day of prednisone) within 2 weeks before starting the study (low-dose or inhaled steroids may be allowed in certain cases — confirm with trial site).
• People who have had palliative or adjuvant radiation therapy, or a type of targeted radiation called gamma knife radiosurgery, within 2 weeks before starting the study.
• People who have received chemotherapy within 2 weeks before starting the study.
• People who have received any experimental cancer drug or device within 4 weeks before starting the study.
• People who have received a live-virus vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, or typhoid) within 4 weeks before starting the study (flu, pneumonia, and COVID-19 vaccines are generally allowed, though not within 7 days before or after a study vaccine injection).
• People who have received allergy desensitisation injections within 4 weeks before starting the study.
• People who have received growth factor medications (such as G-CSF or erythropoietin) within 4 weeks before starting the study.
• People who have had major surgery within 4 weeks before starting the study (minor procedures such as dental work or skin biopsy are generally acceptable).
• People who have previously been treated with certain types of immunotherapy drugs (such as IL-2, interferon, anti-CTLA-4, anti-LAG-3, anti-OX-40, anti-CD137, anti-CD40, or anti-PD-L2 antibodies).
• People who previously received a specific type of immunotherapy called anti-PD(L)-1 (such as durvalumab, atezolizumab, or nivolumab) for early-stage cancer may be considered, but only if their cancer progressed at least 6 months after starting that treatment and they did not have serious immune-related side effects from it.
• People who have had a severe allergic reaction to monoclonal antibody drugs or related substances, or to any previous immunotherapy.
• People who have brain metastases (cancer that has spread to the brain) that are untreated or causing symptoms. People with treated, symptom-free brain metastases may be considered if treatment was completed at least 2 weeks before starting the study and steroid use meets the criteria (confirm with trial site).
• People who have an active autoimmune disease that has required systemic (whole-body) treatment in the last 2 years (some specific conditions such as well-controlled type 1 diabetes, hypothyroidism managed with hormone replacement only, or certain stable skin conditions may be permitted — confirm with trial site).
• People who have a known history of a lung condition called interstitial lung disease or pneumonitis (lung inflammation) that required steroid treatment, or who currently have pneumonitis.
• People whose blood oxygen level (measured by a finger sensor) is below 90% while breathing normal air.
• People who need to use oxygen at home.
• People with a known history of HIV, hepatitis B, or hepatitis C infection.
• People with serious uncontrolled health conditions, such as an active infection, heart failure, unstable angina, irregular heart rhythm, or a psychiatric condition that would make it difficult to follow the study requirements.
• People who have been diagnosed with another cancer or a blood disorder in the past 5 years (some exceptions apply for certain low-risk cancers such as non-melanoma skin cancer, superficial bladder cancer, or low-grade prostate cancer not needing treatment — confirm with trial site).
• People with a known immune deficiency condition.
• People who have received a transplanted organ or tissue from another person (including a cornea), or who have previously had a bone marrow or stem cell transplant from a donor.
• People who, in the judgement of the study investigator, have any other medical or psychiatric reason that makes participation unsuitable.
• People who regularly use illicit drugs or misuse substances including alcohol in a way that could affect their ability to follow the study requirements.
• People who are unwilling or unable to follow the study schedule.
• People who are pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.