Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from the 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 18 or older, of any gender.
• People who have been diagnosed with advanced non-small cell lung cancer (NSCLC) or other solid tumours (such as head and neck cancer or colorectal cancer) that have spread or cannot be surgically removed, and whose cancer has continued to grow after standard treatments, or who cannot tolerate standard treatments, or who have chosen not to receive standard treatments (note: refusing standard treatment is not applicable to Part 2 of the trial).
• For Part 1 of the trial: people whose tumour has tested positive for certain genetic markers — either EGFR (a gene mutation or gene copy increase) and/or MET (a gene copy increase or a specific mutation called exon 14 skipping) in NSCLC; or high EGFR/MET protein levels or gene copy increases in other solid tumours.
• For Part 2 of the trial, people whose tumour fits one of these specific groups based on biomarker testing:
  • Cohort A: Advanced NSCLC with an EGFR mutation that has stopped responding to third-generation EGFR-blocking drugs.
  • Cohort B: Advanced NSCLC with a specific EGFR mutation called exon 20 insertion.
  • Cohort C: Advanced NSCLC with MET gene amplification (too many copies of the MET gene).
  • Cohort D: Advanced NSCLC with a specific MET mutation called exon 14 skipping.
  • Cohort E: Colorectal cancer that has spread or returned and cannot be treated with the aim of cure.
  • Cohort F: Other advanced solid tumours that have not responded to, or cannot tolerate, standard treatments.
  • Cohort G: Locally advanced or metastatic NSCLC, stomach/oesophageal junction cancer, or head and neck squamous cell cancer (from the mouth, throat, or voice box) with high MET levels or MET gene amplification, and no other targetable driver gene, where treatment aimed at cure is not possible.
• People who have measurable or evaluable areas of disease visible on scans, as defined by standard criteria (RECIST v1.1), depending on which part of the trial a person is in.
• People who are reasonably well and able to carry out daily activities, as rated 0 or 1 on a standard medical scale (ECOG performance status).
• People with an expected survival of at least 3 months.
• People with adequate liver, kidney, and blood function (without having needed blood transfusions or certain blood-boosting injections in the 14 days before testing).
• People who are willing and able to follow the trial schedule and attend follow-up visits.
• People who can understand the nature of the trial and are willing to sign a consent form.

Who may not be able to join:

• People with colorectal cancer whose tumour tests positive for the HER-2 protein or gene (confirmed by laboratory testing).
• People who have received another experimental drug or anti-cancer treatment within 14 days before starting the trial drug, or within 5 times the drug's clearance period (whichever is longer); for Cohort E1, people whose last dose of a specific type of cancer antibody (EGFR monoclonal antibody) was less than 6 months before starting the trial drug.
• People who have had major surgery or radiation therapy within 4 weeks before starting the trial drug (limited palliative radiotherapy is allowed if it finished at least 2 weeks beforehand).
• People with colorectal cancer, head and neck squamous cell cancer, or stomach/oesophageal junction cancer who have already received more than three lines of systemic anti-cancer treatment (not counting maintenance therapy).
• People with NSCLC who have already received more than two rounds of chemotherapy for their advanced or metastatic disease (not counting maintenance therapy).
• People with NSCLC and a specific EGFR exon 20 insertion mutation who have previously been treated with certain EGFR-blocking drugs known to target that mutation (such as poziotinib, TAK-788, or similar drugs).
• People who have previously been treated with a bispecific antibody or antibody-drug treatment targeting both EGFR and MET (such as Amivantamab or similar drugs listed in the criteria).
• People who still have side effects from previous cancer treatments that have not recovered to a mild level (Grade 1 or lower), except for hair loss.
• People who have had another type of cancer in the past 3 years, except for cancers that have been fully cured, such as certain skin cancers, cervical cancer in situ, or breast cancer in situ.
• People with a primary brain tumour, cancer that has spread to the lining of the brain or spinal cord, spinal cord compression, risk of brain bleeding, or brain metastases that are currently causing symptoms or have not yet been treated; for Cohorts E, F, and G (except NSCLC patients), people with any known brain or meningeal metastases.
• People with significant heart or blood vessel disease (confirm with trial site for specific conditions).
• People with active hepatitis B (with certain virus levels in the blood), active hepatitis C, HIV, or syphilis infections.
• People with a history of, or current signs of, scarring or inflammation of the lung tissue (interstitial lung disease), including lung damage from previous drugs or radiation, or lung fibrosis; also people with uncontrolled lung inflammation that is not caused by infection.
• People with serious ongoing medical conditions, including uncontrolled active infections, uncontrolled fluid build-up around the lungs or abdomen, active tuberculosis, significant digestive system disease or obstruction, or serious lung, metabolic, or psychiatric conditions.
• Women of childbearing potential who are pregnant or breastfeeding, or who test positive for pregnancy within 7 days before starting treatment; and male or female participants who are unwilling to use effective contraception during the trial and for 3 months after treatment ends, or who plan to have a child during this period.
• People with known allergies or hypersensitivity to the trial drug (MCLA-129) or any of its ingredients.
• People who, in the opinion of the trial doctor, are unlikely or unable to follow the trial procedures, or who are otherwise considered unsuitable for participation.

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