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- A phase Ib /II trial of pembrolizumab and idelalisib in patients with non-small cell lung cancer (NSCLC) who have failed immune checkpoint inhibitor
Clinical Trial
A phase Ib /II trial of pembrolizumab and idelalisib in patients with non-small cell lung cancer (NSCLC) who have failed immune checkpoint inhibitor
This is a phase 1b/2 study to determine the safety and effectiveness of the combination of pembrolizumab and idelalisib in NSCLC patients whose disease has stopped responding to immune therapy. This study is being done to see if adding another immune modulator (idelalisib) to standard pembrolizumab will increase response rates, compared to the response seen with pembrolizumab alone.
Eligibility Criteria
- Summary Inclusion Criteria - Eligible Patients Must: Have documented metastatic or recurrent NSCLC from biopsy, who have failed or progressed on platinum-based chemotherapy (such as cisplatin or carboplatin) as well as immune checkpoint inhibitor therapy (such as nivolumab or pembrolizumab) Have at least one measurable lesion Be able to perform most activities of daily life Summary Exclusion Criteria - Eligible Patients Must NOT: Be currently receiving study drug in another trial; or have participated in an investigational drug study within 3 weeks of the first dose of treatment. Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis; however, patients with previously treated, stable, brain metastases may participate. Have a known history of non-infectious pneumonitis that required steroid use, or have current pneumonitis. Have an active infection or autoimmune disease requiring systemic therapy.
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