Phase 2 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 18 years of age or older at the time of signing the consent form.
• People who have been confirmed by laboratory testing to have Stage IV non-small cell lung cancer (a type of lung cancer) that doctors consider suitable for treatment with pembrolizumab alone, or combined with carboplatin/pemetrexed or paclitaxel (specific cancer medicines).
• People whose cancer can be measured on scans using a standard medical measuring system called RECIST 1.1.
• People who have not yet received treatment for their Stage IV lung cancer at the time of joining the study. People who received certain chemotherapy (platinum-based) at least 6 months before the study start date — either after surgery or alongside radiotherapy for an earlier, non-operable stage of lung cancer — may also be eligible.
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard medical scale (ECOG score of 0 or 1).
• People whose blood counts, kidney function, blood clotting, and liver function all fall within acceptable ranges as measured by specific laboratory tests (confirm with trial site for exact values).
• People whose resting blood oxygen level is at least 90%, and whose lung function tests show results of at least 50% of expected values.
• People who are physically able to correctly handle and use the specific inhalation device used in this trial.
• Women who could become pregnant must have a negative blood pregnancy test and must not be pregnant or breastfeeding at the time of screening.
• People who are able to father children, and women who could become pregnant, must agree to use highly effective contraception throughout the study and for at least 6 months after the last dose of the trial treatment.
• People who have given written consent before any study-related procedures take place.
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete all required tests and procedures.

Who may not be able to join:

• People who are unable or unwilling to have contrast-enhanced CT scans and chest X-rays as required by the study.
• People who have taken part in another clinical trial of an investigational drug or device within 4 weeks before the planned first study treatment date.
• People who have received any cancer treatment within 6 months before the planned first study treatment date.
• People who have previously been treated with an immune checkpoint inhibitor (a type of cancer immunotherapy medicine).
• People who have received radiotherapy to the head, neck, chest, or abdomen within 4 weeks before the planned first study treatment date (or within 2 weeks for palliative radiotherapy), or who have not fully recovered from radiation side effects, or who have had significant radiation-related lung inflammation.
• People currently receiving radiotherapy to the chest area for lung cancer treatment.
• People who have had major surgery within 4 weeks before the planned first study treatment date.
• People whose lung cancer has specific genetic features (such as EGFR mutation or ALK translocation) or other molecular changes that the treating doctor believes could be better treated with targeted therapies.
• People who have never smoked and have not yet had results from EGFR mutation and ALK translocation testing before the planned first study treatment date.
• People with a known pre-existing hearing impairment related to damage of the eighth nerve (the nerve involved in hearing and balance).
• People with a known history of severe intolerance or allergic reaction to cisplatin (a chemotherapy drug), vitamin E, or lactose.
• People with mouth or jaw problems (such as a cleft palate) or other physical differences that would prevent a proper seal with the inhalation device mouthpiece.
• People with uncontrolled symptoms from fluid around the lung (pleural effusion) or a collapsed lung (pneumothorax).
• People who have had surgical removal of an entire lung (pneumonectomy) or removal of two lobes of the lung (bilobectomy), unless the bilobectomy involved only the right middle lobe.
• People with a known history of severe coughing or airway spasm triggered by inhaling dry powder medicines.
• People with a known history of, or current, chronic upper or lower respiratory conditions other than asthma and certain types of rhinitis (nasal inflammation). A past mild respiratory condition may be acceptable if it fully resolved at least 3 months before the planned first study treatment date and the treating doctor considers it poses no additional risk (confirm with trial site).
• People with a known history of certain serious lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, drug-related lung inflammation, interstitial lung disease, or a severe worsening of COPD (chronic obstructive pulmonary disease) in the 3 months before the study start date, or current lung inflammation requiring steroids.
• People with uncontrolled asthma as defined by international guidelines. People with a history of asthma or controlled asthma managed with certain inhaler medicines and having fewer than one asthma episode per month may be eligible.
• People with an uncontrolled or severe active infection.
• People with a known positive HIV status or known history of HIV infection.
• People with active hepatitis B virus (HBV) infection, indicated by a positive surface antigen test at screening. People with a past or resolved HBV infection may be eligible.
• People with active hepatitis C virus (HCV) infection, indicated by both a positive antibody test and a positive RNA test at screening. People who test positive for HCV antibodies but have a negative RNA (PCR) test may be eligible.
• People who test positive for COVID-19 by PCR test — the test must be taken within 72 hours before the planned first study treatment date. Prior vaccination or previous COVID-19 infection does not remove the requirement for this test.
• People who have received a live virus vaccine within 30 days before the planned first study treatment date (note: inactivated flu vaccines are acceptable).
• People who have been taking oral corticosteroid medicines (steroid tablets) above certain dose levels within a specified period before the planned first study treatment date (confirm exact dose limits and timeframes with trial site). People using inhaled or skin-applied corticosteroids may be eligible.
• People who still have ongoing side effects of grade 2 or higher (on a standard medical scale) from previous cancer treatment, except for side effects considered clinically minor, such as hair loss.
• People who currently have another active cancer, with certain exceptions such as adequately treated skin cancers, certain early-stage cancers, or low-grade prostate cancer not requiring treatment. People with a previous cancer history who have been free of disease for at least 3 years may be eligible.
• People with a known history of a blood clot in an artery or vein within 3 months before the planned first study treatment date.
• People with a known history of fainting episodes of unknown or heart-related cause, uncontrolled irregular heart rhythms originating in the lower chambers of the heart, or sudden cardiac arrest.
• People with significant or uncontrolled heart failure with a heart pumping function below 40%, or who have had a significant heart attack or serious heart rhythm problems within 6 months before the planned first study treatment date.
• People with uncontrolled high blood pressure (at or above 150/90 mmHg) that has not been controlled despite taking two or more blood pressure medicines.
• People with a known history of organ transplant or who are currently taking active immunosuppressive medicines (such as cyclosporine or tacrolimus).
• People with a known history or current presence of clinically significant brain or nervous system conditions, any autoimmune disease, or significant blood clotting disorders.
• People with cancer that has spread to the membranes surrounding the brain or spinal cord, or to the brain itself, unless those brain metastases are stable and have already been treated with radiotherapy.
• People with nerve damage affecting the hands or feet greater than grade 1 on a standard medical scale.
• People with any significant medical condition that the treating doctor considers makes participation not in the person's best interest.
• People who are unwilling or unable to follow the study protocol for any other reason.

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