Trial Outcomes & Findings for Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer (NCT NCT02955758)
NCT ID: NCT02955758
Last Updated: 2024-10-09
Results Overview
Circulating tumor DNA (ctDNA) levels will be measured using Cancer personalized profiling by deep sequencing (CAPP Seq) with radiographic tumor assessments using RECIST v1.1 criteria in patients with metastatic NSCLC treated with pembrolizumab. ctDNA will be measured as percentage of total circulating free DNA. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2024-10-09
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All patients enrolled and treated
Circulating tumor DNA (ctDNA) levels will be measured using Cancer personalized profiling by deep sequencing (CAPP Seq) with radiographic tumor assessments using RECIST v1.1 criteria in patients with metastatic NSCLC treated with pembrolizumab. ctDNA will be measured as percentage of total circulating free DNA. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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.
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Correlation of Tumor-informed CAPP-Seq ctDNA Analysis With Radiologic Tumor Assessments
Complete Response (CR)/Partial Response (PR)
|
100 Percent Accuracy
|
|
Correlation of Tumor-informed CAPP-Seq ctDNA Analysis With Radiologic Tumor Assessments
Non-Evaluable (NE)
|
NA Percent Accuracy
Pre/post ctDNA and Radiographic response need to be evaluable to measure primary outcome. No evaluable somatic mutations identified in 3 patients, no evaluable post-treatment plasma available in 3 patients, and follow up radiographic response not performed in 1 patient.
|
|
Correlation of Tumor-informed CAPP-Seq ctDNA Analysis With Radiologic Tumor Assessments
Stable Disease (SD)
|
66 Percent Accuracy
|
|
Correlation of Tumor-informed CAPP-Seq ctDNA Analysis With Radiologic Tumor Assessments
Progressive Disease (PD)
|
100 Percent Accuracy
|
SECONDARY outcome
Timeframe: Up to 2 yearsOverall Response Rate (ORR) defined as proportion of complete responses + partial responses will be measured using RECIST v1.1 criteria
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate (ORR)
|
2 participants
|
SECONDARY outcome
Timeframe: From the time of first treatment with pembrolizumab to the time of progression or death from any cause, whichever comes earlier, assessed up to 2 yearsPopulation: PFS Evaluable Patients by RECIST 1.1
Progression-free survival (PFS) will be measured from the time of first treatment with pembrolizumab to the time of radiographic progression, unequivocal clinical progression, or death from any cause, whichever comes earlier
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
PFS Measured Using RECIST v1.1 Criteria
|
2.6 Months
Interval 1.3 to 4.9
|
SECONDARY outcome
Timeframe: From the time of first treatment with pembrolizumab to the time of death, assessed up to 3 yearsOverall Survival of all treated participants
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival (OS)
|
13.3 Months
Interval 10.3 to 27.8
|
SECONDARY outcome
Timeframe: Up to 2 yearsOutcome measures
| Measure |
Treatment (Pembrolizumab)
n=25 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events Version 4.03
|
25 Participants
|
Adverse Events
Treatment (Pembrolizumab)
Serious events: 9 serious events
Other events: 23 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (Pembrolizumab)
n=25 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Worsening dyspnea
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
abdominal pain
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Recurrence of bilateral pleural effusions
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
worsening of oncologic disease
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Bacterial pneumonia
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Nervous system disorders
syncope
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
sepsis
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Worsening bone pain
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
General disorders
fatigue
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Cardiac disorders
Worsening pericardial effusion with Tamponade
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
General disorders
pain
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Nervous system disorders
altered mental status
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Surgical and medical procedures
Craniotomy
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
Other adverse events
| Measure |
Treatment (Pembrolizumab)
n=25 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Left foot discomfort
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Worsening left hip pain
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
8.0%
2/25 • Number of events 2 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Right-sided muscle weakness
|
4.0%
1/25 • Number of events 2 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Renal failure and altered mental status
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Runny nose (allergies)
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Syncope
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Malaise
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Blood and lymphatic system disorders
Venous distention
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
8.0%
2/25 • Number of events 4 • up to 3 years
|
|
Immune system disorders
Contrast allergic reaction
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Investigations
Elevated AST
|
4.0%
1/25 • Number of events 2 • up to 3 years
|
|
Investigations
Elevated creatinine
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Investigations
Neutrophilia
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
5/25 • Number of events 5 • up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Metabolism and nutrition disorders
Worsening decreased appetite
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Right heel infection
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Rash acneiform on shoulder
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Rash acneiform on face
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Rash acneiform
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Rash acneiform on chest
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Paronychia
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Rash acneiform on back
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Rash acneiform on buttocks
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Rash acneiform on feet
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Rash acneiform on arms
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Neck pain
|
8.0%
2/25 • Number of events 3 • up to 3 years
|
|
Infections and infestations
Worsening muscle weakness
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Rib pain
|
4.0%
1/25 • Number of events 2 • up to 3 years
|
|
Infections and infestations
Left shoulder pain
|
8.0%
2/25 • Number of events 2 • up to 3 years
|
|
Infections and infestations
Post-surgical chest pain
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Intermittent RUE muscle cramps
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Non-cardiac chest pain
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Cramps (arms)
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Cramps (legs)
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Weakness in right hand
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Intermittent achiness
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Infections and infestations
Arthritic pain in hands
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral pleural effusions
|
4.0%
1/25 • Number of events 3 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Anterior chest pain
|
4.0%
1/25 • Number of events 2 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Eye disorders
intermittent blurry vision
|
4.0%
1/25 • Number of events 2 • up to 3 years
|
|
Eye disorders
visual changes
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
24.0%
6/25 • Number of events 9 • up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
8.0%
2/25 • Number of events 4 • up to 3 years
|
|
Gastrointestinal disorders
Worsening abdominal pain
|
20.0%
5/25 • Number of events 5 • up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
2/25 • Number of events 2 • up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
Worsening vomiting
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
Worsening diarrhea
|
12.0%
3/25 • Number of events 3 • up to 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
16.0%
4/25 • Number of events 4 • up to 3 years
|
|
Gastrointestinal disorders
Post-operative abdominal pain
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Gastrointestinal disorders
Mucositis
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Worsening back pain
|
8.0%
2/25 • Number of events 2 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
2/25 • Number of events 2 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Upper back pain
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
4.0%
1/25 • Number of events 2 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
General back pain
|
4.0%
1/25 • Number of events 4 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
4.0%
1/25 • Number of events 3 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Left sided rib pain
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Possible tuberculosis reactivation
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
General disorders
Flu like symptoms
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
General disorders
Lower extremity edema
|
16.0%
4/25 • Number of events 5 • up to 3 years
|
|
General disorders
Fatigue
|
8.0%
2/25 • Number of events 6 • up to 3 years
|
|
General disorders
Neuropathy
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
General disorders
Worsening fatigue
|
12.0%
3/25 • Number of events 3 • up to 3 years
|
|
General disorders
Post-biopsy pain (left rib)
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Nervous system disorders
Neuropathy (Left chest wall)
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 2 • up to 3 years
|
|
Nervous system disorders
Hydrocephalus
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Nervous system disorders
Memory impairment
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Nervous system disorders
Cerebrovascular ischemia
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Nervous system disorders
Worsening headache
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
2/25 • Number of events 2 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
Itchy skin
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Psychiatric disorders
Insomnia
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Vascular disorders
Hypertension
|
8.0%
2/25 • Number of events 3 • up to 3 years
|
|
Vascular disorders
Hot flashes
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Vascular disorders
Worsening hot flashes
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Vascular disorders
Possible temporal arteritis
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Ear and labyrinth disorders
Ear pain
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
|
Reproductive system and breast disorders
Gynecomastia
|
4.0%
1/25 • Number of events 1 • up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place