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Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer (KEYNOTE166)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02448303
Recruitment Status : Completed
First Posted : May 19, 2015
Results First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Acerta Pharma BV

Study Description
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Brief Summary:
Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Pembrolizumab Drug: Acalabrutinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Advanced Non-small Cell Lung Carcinoma
Actual Study Start Date : May 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
pembrolizumab
 Drug: Pembrolizumab
Other Name: Keytruda
Experimental: Arm 2
acalabrutinib plus pembrolizumab
 Drug: Pembrolizumab
Other Name: Keytruda

Drug: Acalabrutinib
Other Name: ACP-196


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Overall Response [ Time Frame: Every 12 weeks for up to 2 years ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448303


Locations
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United States, Arizona
Western Regional Medical Center/Cancer Treatment Center of America
Goodyear, Arizona, United States, 85338
Sponsors and Collaborators
Acerta Pharma BV
Merck Sharp & Dohme LLC
Investigators
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Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com
  Study Documents (Full-Text)

Documents provided by Acerta Pharma BV:
Study Protocol  [PDF] May 23, 2016
Statistical Analysis Plan  [PDF] January 30, 2018

More Information
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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02448303    
Other Study ID Numbers: ACE-ST-007
First Posted: May 19, 2015    Key Record Dates
Results First Posted: September 12, 2019
Last Update Posted: September 12, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pembrolizumab
Acalabrutinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action