Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small cell lung cancer.

Key facts

Study ID

NCT02448303

Run by

Acerta Pharma BV

People needed

74

Starts

2015-05-01

Expected to finish

2018-06-01

Last updated by the study team

2019-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ≥ 18 years of age
• ECOG performance status of 0 or 1
• Histologically confirmed recurrent or metastatic NSCLC (adenocarcinoma, large cell, squamous cell, or not otherwise specified) that has either progressed during or after platinum-based chemotherapy
• Received at least 1 platinum-based chemotherapy regimen. Note: Subjects with EGFR mutations or ALK translocations are required to have received prior therapy with appropriate TKI; prior platinum-based chemotherapy is not required for this specific patient population

You may not qualify if…

• Prior malignancy (other than lung cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years
• Known central nervous system metastases and/or carcinomatous meningitis
• Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
• Breastfeeding or pregnant

Where it is running

• Western Regional Medical Center/Cancer Treatment Center of America — Goodyear, Arizona, United States

Full record on ClinicalTrials.gov

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