Clinical trial · Interventional
Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer
A Phase 2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Advanced Non-small Cell Lung Carcinoma
NCT02448303CI-TRIAL-00040533KEYNOTE166completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acalabrutinib | Drug | Acalabrutinib | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- pembrolizumab
- interventionNames
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- acalabrutinib plus pembrolizumab
- interventionNames
- Drug: Pembrolizumab
- Drug: Acalabrutinib
Primary outcomes (1)
- measure
- Number of Participants With Overall Response
- timeFrame
- Every 12 weeks for up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.