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 aged between 19 and 80 years old at the time of signing the consent form, of any gender.
• People who have been confirmed (through lab testing of tissue samples) to have a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) at an advanced stage (Stage IIIB–IV).
• People whose lung cancer has tested negative for both EGFR mutation and ALK translocation — two specific genetic markers that must be documented before joining.
• People who are able to provide a tumour tissue sample (either recently collected or stored within the last 6 months) that can produce at least 10 prepared slides for testing — samples from fine needle aspiration, fluid smear, or certain bone specimens are not acceptable.
• People who have not previously received chemotherapy for advanced or metastatic lung cancer — prior chemotherapy given before or after surgery, or alongside radiotherapy, may be acceptable if it was completed at least 12 months before the advanced/metastatic diagnosis.
• People who have at least one tumour that can be measured on a CT or MRI scan, with that scan taken within 28 days before starting treatment.
• People with a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or have minor limitations in physical activity (confirm with trial site).
• People with an expected survival of at least 3 months.
• People whose blood test results from within 14 days before starting treatment meet specific levels for red and white blood cells, platelets, liver function, kidney function, and blood clotting — without having received blood transfusions or certain medications in the 14 days prior to those tests (confirm with trial site for specific values).
• Women who could become pregnant must have a negative blood pregnancy test within 3 days before starting treatment, and both women who could become pregnant and men whose partners could become pregnant must agree to use reliable contraception during the study and for 180 days after the last dose.
• People who have voluntarily agreed to take part and have signed a written consent form.

Who may not be able to join:

• People whose lung cancer is of a different type, including mixed or small cell components, or tumours with neuroendocrine features.
• People whose lung cancer tests positive for EGFR mutation or ALK translocation.
• People who do not have any tumour that can be measured on a scan.
• People with cancer that has spread to the membranes around the brain (carcinomatous meningitis) or is compressing the spinal cord.
• People with untreated brain metastases — people with previously treated brain metastases may be considered if the metastases are in specific brain regions, are stable for at least 4 weeks, neurological symptoms have settled, and steroid doses (if used) have been reduced to a low stable level for at least 2 weeks before starting treatment (confirm with trial site).
• People whose cancer could potentially be treated with surgery or high-dose curative radiotherapy.
• People who have previously received treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA4 immunotherapy drugs.
• People with active, known, or suspected autoimmune diseases — some stable, well-managed conditions may be considered eligible (confirm with trial site).
• People who have needed systemic corticosteroids (such as prednisone above 10 mg/day) or other immune-suppressing medications in the 14 days before starting treatment, except for inhaled or topical steroids and low-dose hormone replacement for adrenal conditions.
• People who have received cancer vaccines or immune-stimulating treatments (such as interferon, interleukin, thymosin, or immune cell therapy) within 1 month before starting treatment.
• People who are currently taking part in another clinical trial or received an experimental treatment within 4 weeks (or 5 half-lives of that treatment) before starting treatment.
• People who are expected to need other anti-cancer treatments (such as other medications, radiotherapy, or surgery) while in the study.
• People who have had major surgery within 4 weeks, significant radiation therapy to the chest within 24 weeks, radiation to other areas within 4 weeks, or palliative radiotherapy within 2 weeks before starting treatment — and have not recovered from related side effects.
• People with suspected or confirmed interstitial lung disease, or other significant lung conditions that seriously affect breathing.
• People currently needing treatment for another active cancer.
• People with a history of other cancers, unless the cancer was a specific type (such as certain skin cancers or cervical pre-cancer) that has been in complete remission for at least 5 years and requires no further treatment.
• People with significant heart conditions, including moderate-to-severe coronary artery disease, heart attack, poorly controlled irregular heartbeat, or poor heart pumping function (LVEF below 50% or NYHA Class III–IV heart failure).
• People who have coughed up half a teaspoon (2.5 mL) or more of blood per day within 1 month before joining.
• People who have had clinically significant bleeding or a clear tendency to bleed (such as stomach bleeding or bleeding ulcers) within 1 month before joining.
• People who have had a blood clot event (such as stroke, deep vein thrombosis, or pulmonary embolism) within 3 months before joining.
• People with active tuberculosis (TB), or a history of active TB within the past year.
• People who have had a serious infection requiring hospitalisation within 4 weeks before starting treatment, or who have any currently active infection.
• People who have had or are planned to have a tissue or organ transplant.
• People who have received or plan to receive a live vaccine within 30 days before starting treatment.
• People with gout, chickenpox, shingles, or nerve damage of Grade 2 or higher, as these are listed as reasons platinum-based chemotherapy may not be suitable.
• People with uncontrolled cancer-related pain that has not been stabilised on a consistent pain management plan before joining.
• People with a known positive HIV status or AIDS.
• People with untreated active hepatitis B or C, or co-infection with both hepatitis B and C.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires repeated drainage.
• People with a history of severe allergic reactions to monoclonal antibody therapies, infusion reactions, or severe allergies to pemetrexed, carboplatin, or their associated pre-medications.
• People with mental health conditions, alcohol misuse, inability to stop smoking, or substance use disorders that would interfere with taking part in the trial.
• People who, in the opinion of the treating doctor, have any other condition, history, or circumstance that could affect the trial results or that would not be in their best interest.

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