Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatments pembrolizumab, acalabrutinib
Phase phase 2
Targets BTK, PD-1
Sponsor Acerta Pharma BV
Collaborator Merck Sharp & Dohme Corp.
Start date May 2015
End date June 2017
Trial size 74 participants
Trial identifier NCT02448303, ACE-ST-007

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
pembrolizumab
pembrolizumab Keytruda
(Experimental)
acalabrutinib plus pembrolizumab
pembrolizumab Keytruda
acalabrutinib ACP-196

Primary Outcomes

Measure
The overall response rate (ORR) of pembrolizumab monotherapy and the combination of acalabrutinib and pembrolizumab in subjects with recurrent or metastatic NSCLC
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Acerta Pharma BV.