Trial · NCT02638090
Pembro and Vorinostat for Patients With Stage IV Non-small Cell Lung Cancer (NSCLC)
NCT02638090, Phase 1, Phase 2, Active not recruiting, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2025-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembro and Vorinostat for Patients With Stage IV Non-small Cell Lung Cancer (NSCLC). Trials, record NCT02638090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02638090
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembro and Vorinostat for Patients With Stage IV Non-small Cell Lung Cancer (NSCLC)
- NCT number
- NCT02638090
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Interventions
- Vorinostat, Pembrolizumab
- First posted
- 2015-12-22
- Last updated
- 2026-10-06
- Results first posted
- 2025-05-04
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: Maximum Tolerated Dose (MTD) | Up to 12 months | The maximum tolerated dose (MTD) corresponding to a risk of dose limiting toxicity (DLT) occurring in 30% of patients. DLTs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03). A DLT will be defined as any Grade 3 or higher toxicity that occurs during the DLT evaluation period. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition. |
| Secondary | Phase II: Progression Free Survival (PFS) Per Treatment Arm | Up to 2 years | PFS will be measured from the start of treatment with pembrolizumab and vorinostat until the documentation of disease progression or death due to any cause, whichever occurs first. Progression: One or more of the following must occur: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. |
| Other | Phase II: Objective Response Rate (ORR) Per Treatment Arm | Up to 2 years | Complete response (CR) or partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1. The ORR will be estimated by calculating the proportion of participants who achieve OR; the 80% confidence interval (CI) and 95% CI for the OR rate will be estimated using the exact binomial distribution. CR: Complete disappearance of all target and non-target lesions (exception: lymph nodes mentioned below). No new lesions. No disease related symptoms. Any lymph nodes (target or non-target) must have reduction in short axis to \< 1.0 cm. All disease must be assessed using the same technique as baseline. PR: Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I: Maximum Tolerated Dose (MTD) | Up to 12 months | Milligrams of Vorinostat | NUMBER | |
| SECONDARY | Phase II: Progression Free Survival (PFS) Per Treatment Arm | Up to 2 years | Months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Phase II: Objective Response Rate (ORR) Per Treatment Arm | Up to 2 years | Percentage of Participants with OR | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I: Maximum Tolerated Dose (MTD) | Phase I Dose Escalation | 400 | Milligrams of Vorinostat | ||
| Phase II: Progression Free Survival (PFS) Per Treatment Arm | Arm A: Pembrolizumab | 4.5 | 95% Confidence Interval 2.1 to 9.3 | Months | |
| Phase II: Progression Free Survival (PFS) Per Treatment Arm | Arm B: Pembrolizumab Plus Vorinostat | 4.3 | 95% Confidence Interval 2.8 to 9.4 | Months | |
| Phase II: Objective Response Rate (ORR) Per Treatment Arm | Arm A: Pembrolizumab | 28 | Percentage of Participants with OR | ||
| Phase II: Objective Response Rate (ORR) Per Treatment Arm | Arm B: Pembrolizumab Plus Vorinostat | 41 | Percentage of Participants with OR |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1- Dose Level 1 | 5 | |
| Overall Study | STARTED | Phase I - Dose Level 2 | 9 | |
| Overall Study | STARTED | Phase Ib Expansion | 20 | |
| Overall Study | STARTED | Arm A: Pembrolizumab | 40 | |
| Overall Study | STARTED | Arm B: Pembrolizumab Plus Vorinostat | 46 | |
| Overall Study | COMPLETED | Phase 1- Dose Level 1 | 4 | |
| Overall Study | COMPLETED | Phase I - Dose Level 2 | 9 | |
| Overall Study | COMPLETED | Phase Ib Expansion | 20 | |
| Overall Study | COMPLETED | Arm A: Pembrolizumab | 40 | |
| Overall Study | COMPLETED | Arm B: Pembrolizumab Plus Vorinostat | 43 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,295
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Phase I Dose Escalation - Level 1 | 1 | 5 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Phase I Dose Escalation - Level 2 | 2 | 9 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Phase Ib Expansion | 7 | 20 | 12 |
| other | Diarrhea | Gastrointestinal disorders | Arm A: Pembrolizumab | 8 | 40 | 10 |
| other | Diarrhea | Gastrointestinal disorders | Arm B: Pembrolizumab Plus Vorinostat | 27 | 46 | 32 |
| other | Nausea | Gastrointestinal disorders | Phase I Dose Escalation - Level 1 | 2 | 5 | 2 |
| other | Nausea | Gastrointestinal disorders | Phase I Dose Escalation - Level 2 | 0 | 9 | 0 |
| other | Nausea | Gastrointestinal disorders | Phase Ib Expansion | 8 | 20 | 10 |
| other | Nausea | Gastrointestinal disorders | Arm A: Pembrolizumab | 5 | 40 | 5 |
| other | Nausea | Gastrointestinal disorders | Arm B: Pembrolizumab Plus Vorinostat | 24 | 46 | 32 |
1 to 10 of 1,295Source ClinicalTrials.gov
See all 1,295 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I Dose Escalation - Level 1 | 5 | 5 |
| Total, all-cause mortality | Phase I Dose Escalation - Level 2 | 9 | 9 |
| Total, all-cause mortality | Phase Ib Expansion | 18 | 20 |
| Total, all-cause mortality | Arm A: Pembrolizumab | 35 | 40 |
| Total, all-cause mortality | Arm B: Pembrolizumab Plus Vorinostat | 40 | 46 |
| Total, other adverse events | Phase I Dose Escalation - Level 1 | 5 | 5 |
| Total, other adverse events | Phase I Dose Escalation - Level 2 | 8 | 9 |
| Total, other adverse events | Phase Ib Expansion | 20 | 20 |
| Total, other adverse events | Arm A: Pembrolizumab | 40 | 40 |
| Total, other adverse events | Arm B: Pembrolizumab Plus Vorinostat | 45 | 46 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02638090
GET https://conductscience.org/api/trials/v1/NCT02638090/events?page=2