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

NCT02448303 | Completed Phase 2 Results

• 1 other identifier: ACE-ST-007
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Overall Response

  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

  Every 12 weeks for up to 2 years

Study Arms (2)

Arm 1

EXPERIMENTAL

pembrolizumab

Drug: Pembrolizumab

Arm 2

EXPERIMENTAL

acalabrutinib plus pembrolizumab

Drug: Pembrolizumab; Drug: Acalabrutinib

Interventions

Pembrolizumab DRUG

Also known as: Keytruda

Arm 1; Arm 2

Acalabrutinib DRUG

Also known as: ACP-196

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Acerta Pharma BV: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Western Regional Medical Center/Cancer Treatment Center of America

Goodyear, Arizona, 85338, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; acalabrutinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Priti Patel, MD, Executive Director - Head of Clinical Development
• Organization: Acerta Pharma, LLC

acertamc@dlss.com

1-888-292-9613

Study Officials

• Acerta Clinical Trials

  1-888-292-9613; acertamc@dlss.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 19, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 12, 2019
• Results First Posted: September 12, 2019

Record last verified: 2019-08

Locations

US (1)