Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small cell lung cancer.
Interventions
DRUGPembrolizumab
DRUGAcalabrutinib
Sponsors
Merck Sharp & Dohme LLC
Acerta Pharma BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - Pembrolizumab Monotherapy Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W). | 33 |
| Arm 2 - Acalabrutinib + Pembrolizumab Acalabrutinib 100mg PO BID plus Pembrolizumab 200mg administered as an intravenous (IV) infusion every 3 weeks (Q3W). | 35 |
| Total | 68 |
Baseline characteristics
| Characteristic | Arm 1 - Pembrolizumab Monotherapy | Total | Arm 2 - Acalabrutinib + Pembrolizumab |
|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 10.2 | 64.2 years STANDARD_DEVIATION 9.7 | 64.6 years STANDARD_DEVIATION 9.33 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 66 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 52 Participants | 27 Participants |
| Region of Enrollment United States | 33 participants | 68 participants | 35 participants |
| Sex: Female, Male Female | 15 Participants | 35 Participants | 20 Participants |
| Sex: Female, Male Male | 18 Participants | 33 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 18 / 33 | 23 / 35 |
| other Total, other adverse events | 33 / 33 | 35 / 35 |
| serious Total, serious adverse events | 12 / 33 | 18 / 35 |
Outcome results
Primary
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
Time frame: Every 12 weeks for up to 2 years
Population: The study participants had to have a minimum of one scan (for tumor assessment) after randomization/treatment in order to be considered analyzed.~And some of the participants didn't make it to Wk 7 of treatment, hence reduction in the number of subjects analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 - Pembrolizumab Monotherapy | Number of Participants With Overall Response | 4 Participants |
| Arm 2 - Acalabrutinib + Pembrolizumab | Number of Participants With Overall Response | 4 Participants |