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

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Pembrolizumab; Drug: Acalabrutinib

• Registration Number: NCT02448303
• Lead Sponsor: Acerta Pharma BV

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-05-15
• Study First Posted: 2015-05-19
• Primary Completion: 2018-03
• Study Completion: 2018-06
• Results First Submitted: 2019-07-19
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-22
• Last Update Submitted: 2019-08-22
• Results First Posted: 2019-09-12
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Pembrolizumab	acalabrutinib plus pembrolizumab
Arm 1	Pembrolizumab	pembrolizumab
Arm 2	Acalabrutinib	acalabrutinib plus pembrolizumab

Primary Outcome Measures

Name	Time	Method
Number of Participants With Overall Response	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

Trial Locations

Locations (1)

Western Regional Medical Center/Cancer Treatment Center of America; 🇺🇸 Goodyear, Arizona, United States