Trial Outcomes & Findings for Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer (NCT NCT03425006)
NCT ID: NCT03425006
Last Updated: 2023-09-13
Results Overview
Responses will be compared subject's baseline assessment and historical controls using pembrolizumab monotherapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-09-13
Participant Flow
Participant milestones
| Measure |
Itacitinib and Pembrolizumab
Dose and Route of Administration
* Itacitinib: 200mg PO (extended release formulation)
* Pembrolizumab: 200mg IV infusion over 30 minutes Regimen
* Treatment = 3 week (Q3W) dosing cycles
* Itacitinib: Once daily for Cycle 3 and Cycle 4 (up to 6 weeks)
* Pembrolizumab: Q3 week cycles of treatment beginning at Day 1
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Itacitinib and Pembrolizumab
Dose and Route of Administration
* Itacitinib: 200mg PO (extended release formulation)
* Pembrolizumab: 200mg IV infusion over 30 minutes Regimen
* Treatment = 3 week (Q3W) dosing cycles
* Itacitinib: Once daily for Cycle 3 and Cycle 4 (up to 6 weeks)
* Pembrolizumab: Q3 week cycles of treatment beginning at Day 1
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Itacitinib and Pembrolizumab
n=23 Participants
Itacitinib: a JAK 1 selective small molecule inhibitor
Pembrolizumab: a highly selective humanized monoclonal antibody (mAb)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Of the 23 subjects enrolled, 2 subjects were not included in analysis because they did not receive Itacitinib due to pembrolizumab toxicity or subject withdrawal.
Responses will be compared subject's baseline assessment and historical controls using pembrolizumab monotherapy.
Outcome measures
| Measure |
Itacitinib and Pembrolizumab
n=21 Participants
Itacitinib: a JAK 1 selective small molecule inhibitor
Pembrolizumab: a highly selective humanized monoclonal antibody (mAb)
|
|---|---|
|
Number of Subjects With a Response at 12 Weeks According to RECIST 1.1 for the Combination of Pembrolizumab and Itacitinib Among Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC.
|
13 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Of the 23 subjects enrolled, 3 subjects were not included in analysis because they only received pembrolizumab and not itacitinib.
Number of subjects treated with the combination.
Outcome measures
| Measure |
Itacitinib and Pembrolizumab
n=20 Participants
Itacitinib: a JAK 1 selective small molecule inhibitor
Pembrolizumab: a highly selective humanized monoclonal antibody (mAb)
|
|---|---|
|
Number of Subjects With Toxicities (CTCAE v5.0 Scoring) of Pembrolizumab and Itacitinib in Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC
|
20 Participants
|
SECONDARY outcome
Timeframe: 12 weeksNumber of participants who remained progression free at week 12
Outcome measures
| Measure |
Itacitinib and Pembrolizumab
n=23 Participants
Itacitinib: a JAK 1 selective small molecule inhibitor
Pembrolizumab: a highly selective humanized monoclonal antibody (mAb)
|
|---|---|
|
Number of Participants Who Had a Progression Free Survival (PFS) Treated With Pembrolizumab and Itacitinib.
|
20 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Of the 23 subjects enrolled, 2 subjects were not included in analysis because they did not receive Itacitinib.
Outcome measures
| Measure |
Itacitinib and Pembrolizumab
n=21 Participants
Itacitinib: a JAK 1 selective small molecule inhibitor
Pembrolizumab: a highly selective humanized monoclonal antibody (mAb)
|
|---|---|
|
Number of Participants Treated With Pembrolizumab and Itacitinib, Who Had a Minimum Duration of Response (DOR) of 12 Weeks.
|
13 Participants
|
SECONDARY outcome
Timeframe: 16 weeksNumber of subjects treated with pembrolizumab and itacitinib that survived to week 16.
Outcome measures
| Measure |
Itacitinib and Pembrolizumab
n=23 Participants
Itacitinib: a JAK 1 selective small molecule inhibitor
Pembrolizumab: a highly selective humanized monoclonal antibody (mAb)
|
|---|---|
|
Overall Survival (OS) for Subjects Treated With Pembrolizumab and Itacitinib.
|
23 Participants
|
Adverse Events
Itacitinib and Pembrolizumab
Serious events: 6 serious events
Other events: 22 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Itacitinib and Pembrolizumab
n=23 participants at risk
Itacitinib: a JAK 1 selective small molecule inhibitor
Pembrolizumab: a highly selective humanized monoclonal antibody (mAb)
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Stomach pain
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Lung infection
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Fracture
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Myasthenia gravis
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Nervous system disorders - Other
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Seizure
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
|
Vascular disorders
Hypertension
|
4.3%
1/23 • Number of events 1 • 16 weeks
|
Other adverse events
| Measure |
Itacitinib and Pembrolizumab
n=23 participants at risk
Itacitinib: a JAK 1 selective small molecule inhibitor
Pembrolizumab: a highly selective humanized monoclonal antibody (mAb)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.0%
3/23 • Number of events 3 • 16 weeks
|
|
Endocrine disorders
Hypothyroidism
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
8.7%
2/23 • Number of events 3 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
30.4%
7/23 • Number of events 9 • 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
26.1%
6/23 • Number of events 6 • 16 weeks
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
General disorders
Edema limbs
|
13.0%
3/23 • Number of events 3 • 16 weeks
|
|
General disorders
Fatigue
|
34.8%
8/23 • Number of events 8 • 16 weeks
|
|
General disorders
Fever
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
General disorders
Flu like symptoms
|
13.0%
3/23 • Number of events 3 • 16 weeks
|
|
General disorders
Non-cardiac chest pain
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
General disorders
Pain
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Infections and infestations
Lung infection
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Investigations
Blood bilirubin increased
|
8.7%
2/23 • Number of events 3 • 16 weeks
|
|
Investigations
Creatinine increased
|
21.7%
5/23 • Number of events 5 • 16 weeks
|
|
Investigations
Platelet count decreased
|
13.0%
3/23 • Number of events 3 • 16 weeks
|
|
Investigations
Weight gain
|
17.4%
4/23 • Number of events 4 • 16 weeks
|
|
Investigations
Weight loss
|
8.7%
2/23 • Number of events 3 • 16 weeks
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.4%
4/23 • Number of events 4 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.0%
3/23 • Number of events 3 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.4%
4/23 • Number of events 4 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.4%
4/23 • Number of events 4 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Nervous system disorders
Dizziness
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Nervous system disorders
Headache
|
21.7%
5/23 • Number of events 6 • 16 weeks
|
|
Psychiatric disorders
Insomnia
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.4%
7/23 • Number of events 7 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.0%
3/23 • Number of events 3 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
13.0%
3/23 • Number of events 3 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.0%
3/23 • Number of events 3 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
|
Vascular disorders
Hypertension
|
8.7%
2/23 • Number of events 2 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place