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 have been diagnosed with advanced or metastatic non-squamous non-small cell lung cancer (a specific type of lung cancer) that cannot be fully removed by surgery or treated with radiation to cure it.
• People whose tumor has a specific genetic change — either a mutation in a gene called EGFR (specifically L858R or exon 19 deletion), or a fusion (abnormal joining) involving the genes ALK, ROS1, RET, or NTRK1-3 — confirmed by laboratory testing. Note: the number of people with EGFR mutations is limited to a maximum of 10 in this trial.
• People who have already received specific targeted treatments called TKIs (drugs that block certain cancer-driving proteins), as follows: a third-generation EGFR TKI (such as osimertinib or lazertinib) for EGFR mutations; a third- or fourth-generation ALK TKI (such as lorlatinib or neladalkib) for ALK fusions; specific drugs such as crizotinib, entrectinib, repotrectinib, or taletrectinib for ROS1 fusions; selpercatinib or pralsetinib for RET fusions; or entrectinib, larotrectinib, or repotrectinib for NTRK1-3 fusions.
• For one treatment group (ivonescimab alone): people who have also already received platinum/pemetrexed chemotherapy, with no restriction on how many prior treatments they have had.
• For the other treatment group (ivonescimab combined with carboplatin and pemetrexed): people who have not received any prior chemotherapy, with no restriction on how many prior TKI treatments they have had.
• People who have at least one measurable area of cancer that can be tracked on scans, as assessed by the study team.
• People who are willing to have a tissue sample (biopsy) taken before treatment starts and again if the cancer grows or changes. An on-treatment biopsy may also be required depending on the treatment group. In some cases exceptions may be possible if a biopsy is considered medically unsafe or not feasible (confirm with trial site).
• People who have brain metastases (cancer that has spread to the brain) that are not causing symptoms, as long as steroid doses have not been increased in the two weeks before joining the trial.
• People aged 18 or older.
• People who are generally well enough to carry out daily activities with little to no limitation (as assessed using a standard scale called ECOG, score of 0 or 1).
• People whose blood counts, kidney function, liver function, and blood clotting results meet specific minimum levels as measured by blood and urine tests (the trial team will check these at screening).
• Women who could become pregnant must have a negative pregnancy test before starting treatment and agree to use highly effective contraception from the start of screening until at least 90 days after the last dose of ivonescimab, or 6 months after the last dose of carboplatin or pemetrexed.
• Men who have not been surgically sterilised and who have a partner who could become pregnant, or who have a pregnant or breastfeeding partner, must agree to use a condom throughout treatment and for at least 90 days after the last dose of any study drug, and their partner must also use at least one highly effective form of contraception for the same period.

Who may not be able to join:

• People who have previously been treated with certain immune system drugs called checkpoint inhibitors (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies).
• People who have had major surgery or serious injury within 4 weeks before the first dose, or who are planning major surgery within 4 weeks after the first dose. People who have had minor procedures within 3 days before the first dose may also be excluded (confirm with trial site).
• People who have a history of significant bleeding problems or blood clotting disorders, or who have had clinically significant bleeding within the 4 weeks before starting the trial — including coughing up blood (half a teaspoon or more), nosebleeds, or unstable use of blood-thinning or anti-clotting medications.
• People with high blood pressure that is not well controlled despite taking blood pressure medication (systolic repeatedly 150 mmHg or higher, or diastolic 100 mmHg or higher).
• People who have an active autoimmune condition or active lung disease requiring certain ongoing medications (such as stronger steroids or immune-suppressing drugs) within the past 2 years — though some replacement hormone therapies and inhaled treatments are permitted.
• People who have had certain serious heart or blood vessel conditions requiring hospitalisation within the past 6 months, such as heart attack, unstable angina, significant heart failure, aortic aneurysm, or uncontrolled heart rhythm problems.
• People who have had serious stomach or bowel problems within the past 6 months, such as active ulcers, gastrointestinal bleeding, bowel perforation, bowel obstruction, or abdominal abscesses.
• People who have had a blood clot in an artery, a serious blood clot in a vein, a mini-stroke or stroke, or a hypertensive crisis within the past 6 months.
• People who have had a severe flare-up of chronic obstructive pulmonary disease (a lung condition) within the past 4 weeks.
• People whose scans show that the cancer is growing into or wrapping around major blood vessels or important nearby organs (such as the heart, main airway, or oesophagus), or where the investigator believes there is a significant risk of bleeding or of a hole forming between the oesophagus and other structures.
• People with brain metastases that are causing symptoms, that are bleeding, that are 1.5 cm or larger, or who have received brain radiation within 7 days before the first dose. People with cancer spread to the lining around the brain and spinal cord (leptomeningeal disease) are also excluded.
• People who have received a live vaccine within 4 weeks before starting the trial, or who expect to need one during the trial.
• People who have had a severe infection requiring hospitalisation within the past 4 weeks, or an active infection requiring systemic antibiotic, antifungal, or antiviral treatment (other than hepatitis B or C treatment) within the past 2 weeks.
• People who have pre-existing nerve damage in their hands or feet that is moderate or worse in severity (Grade 2 or above).
• People with uncontrolled build-up of fluid around the lungs, heart, or in the abdomen that is causing symptoms — though people managed with a drainage tube already in place may be allowed (confirm with trial site).
• People who have current or past lung inflammation (interstitial lung disease or pneumonitis) that required treatment with steroids.
• People who have a history of inflammatory bowel disease such as Crohn's disease or ulcerative colitis, or chronic diarrhoea.
• People with HIV whose viral levels are not well controlled.
• People currently taking steroid medication at a dose higher than the equivalent of 10 mg of prednisone per day.
• People who have had an organ transplant or bone marrow/stem cell transplant from another person.
• People with active hepatitis B whose virus levels have not been stable or declining on appropriate antiviral medication for at least one month before starting the trial. People with active hepatitis C are excluded.
• People with a known allergy to any component of the study drugs, or a history of severe allergic reactions to similar medicines (monoclonal antibodies).
• People with any other medical, surgical, or psychiatric condition — or laboratory result — that the treating doctor believes would make participation unsafe, interfere with the study, or not be in the person's best interest.
• People who are currently breastfeeding or plan to breastfeed during the study.

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