Phase 3 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 are at least 18 years old at the time of signing the consent form.
• People who have been diagnosed with stage 3b or stage 4 non-small cell lung cancer (NSCLC), confirmed by a tissue or cell sample analysis.
• People who have already received two prior treatment courses for advanced or metastatic disease, which must have included an immune checkpoint inhibitor (a type of immunotherapy that targets PD-1 or PD-L1) and a platinum-based chemotherapy (given together or separately).
• People whose cancer has grown or worsened after their most recent treatment, or who were unable to tolerate it (with additional specific requirements depending on whether the diagnosis is stage 3b or stage 4).
• People whose cancer responded well to their prior immunotherapy for at least 6 months before eventually stopping working (this is called "secondary resistance," confirm with trial site).
• People who have never received targeted therapy aimed at specific gene mutations driving their cancer.
• People who have at least one tumour that can be measured on scans, according to standard criteria (RECIST v1.1), and that has been confirmed to have grown since their last treatment.
• People who can provide an archived tumour tissue sample, if one is available (people without a sample may still be considered with approval from the trial's medical monitor).
• People who are in good general health and able to carry out daily activities with little or no limitation (rated 0 or 1 on a standard performance scale).
• People whose blood tests show that their bone marrow, liver, and kidneys are functioning at adequate levels within 14 days before starting the trial treatment.
• Women who could become pregnant must have a negative blood pregnancy test within 72 hours before starting treatment.
• People who are willing and able to use effective contraception during the trial and for six months after the last dose of study treatment, as specified for each treatment arm (confirm specific requirements with trial site).
• People who are able and willing to provide signed informed consent and follow the trial's requirements.

Who may not be able to join:

• People whose cancer did not respond to prior immunotherapy, or whose disease was stable for less than 6 months before progressing (known as "primary resistance"), unless they had a partial or complete response before progressing.
• People who have untreated or currently symptomatic brain metastases (people with treated brain metastases that are not causing symptoms may still be considered).
• People who have received chemotherapy or non-biological targeted therapy within the past 28 days, or biological targeted therapy, immunotherapy, or radiation therapy within the past 42 days before starting the trial (some exceptions may apply with medical monitor approval).
• People who have previously been treated with cemiplimab (one of the drugs used in this trial).
• People who have previously received a targeted therapy specifically for an EGFR gene mutation.
• People who have received a blood, red blood cell, or platelet transfusion within the past 14 days before starting the trial.
• People who have received any type of vaccine (live, inactivated, or research-based) within the past 30 days (standard injected flu vaccines are generally allowed).
• People who have had a bone marrow or organ transplant from a donor.
• People who have had major surgery within the past 28 days before starting the trial.
• People who have not yet recovered from side effects of previous cancer treatments (side effects must be at a mild level or resolved).
• People who are still experiencing ongoing immune-related side effects from prior immunotherapy, or who had to permanently stop a prior immunotherapy due to immune-related side effects (people with fully resolved side effects may be considered after consultation with the medical monitor).
• People with active gastrointestinal bleeding (such as vomiting blood or passing black stools).
• People with a history of another active cancer, except for certain skin cancers or very early-stage cervical abnormalities, unless that cancer has been in complete remission with no treatment for at least three years.
• People who need ongoing treatment with high-dose steroid medications or other immune-suppressing drugs (above a specified threshold) within the past 14 days (inhaled or topical steroids and low-dose steroids may be permitted in certain circumstances).
• People with active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment within the past 14 days.
• People who test positive for HIV, or who have active hepatitis B or hepatitis C infection.
• People with significant heart disease, including a history of serious heart failure, heart attack, or unstable chest pain within the past six months.
• People whose heart's electrical activity shows a prolonged interval on an ECG (QTcF greater than 480 milliseconds), unless they have a pacemaker or specific heart conduction issue, which may be considered with medical monitor approval.
• People with active autoimmune diseases, or a history of autoimmune conditions that may return — with some exceptions including well-controlled type 1 diabetes, thyroid conditions managed with hormone replacement, controlled coeliac disease, and certain skin conditions not requiring systemic treatment.
• People who are pregnant or currently breastfeeding.
• People with serious non-cancer-related conditions (such as uncontrolled illness, significant psychiatric conditions, substance misuse, or interstitial lung disease) that the investigator believes could interfere with the trial.
• People with any other condition that, in the investigator's opinion, would prevent safe participation in the trial.
• People who are currently enrolled in another clinical trial involving an experimental treatment or unapproved use of a drug or device.
• People with a known allergy to any of the ingredients in THIO, cemiplimab, or any of the chemotherapy drugs used in this trial.

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