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 non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body, confirmed by a laboratory test on a tissue or cell sample.
• People who have at least one tumour that can be measured on a scan, as assessed by the trial doctor using standard measurement guidelines.
• For the dose escalation and dose confirmation groups: people whose cancer got worse after being treated with a type of targeted drug called an EGFR-TKI, and whose tumour tissue shows a positive result for a protein called PDL1 (at a level of 1% or more).
• For the dose expansion group: people who have not previously received any systemic (whole-body) cancer treatment for their advanced or metastatic disease, and whose tumour tissue shows a positive PDL1 result (at 1% or more), as confirmed by the central laboratory.
• People whose blood counts and organ function (such as liver and kidneys) are within acceptable ranges based on lab tests.
• People whose tumour or blood sample has been confirmed by genetic testing to carry a specific change in the EGFR gene — either the L858R mutation or an exon 19 deletion.

Who may not be able to join:

• People whose NSCLC is mainly of a type called squamous cell, or whose cancer includes small cell lung cancer or neuroendocrine carcinoma.
• People who have a history of, or currently have, a serious lung inflammation condition called interstitial lung disease (ILD) or pneumonitis.
• People who have compression of the spinal cord, or brain metastases that are causing symptoms or require treatment with steroids or anti-seizure medications (people with inactive, non-symptomatic brain metastases may still be considered).
• People who still have significant side effects from a previous cancer treatment that have not returned to a mild or baseline level (hair loss is an exception).
• People who are currently taking corticosteroids (such as prednisone) at a dose greater than 10 mg per day, or any other medication that suppresses the immune system.
• People with uncontrolled or serious heart or blood vessel disease.
• People with HIV that is not well managed.
• People with other severe or uncontrolled health conditions that the trial doctor believes would make participation unsuitable.

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