Trial Outcomes & Findings for Ramucirumab and Pembrolizumab for the Treatment of EGFR Mutant Recurrent or Metastatic Non-small Cell Lung Cancer (NCT NCT04120454)
NCT ID: NCT04120454
Last Updated: 2025-07-11
Results Overview
Response rate will be evaluated with computed tomography (CT) scans every 2 cycles and tumor measurements using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Immune RECIST (iRECIST) will also be assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2025-07-11
Participant Flow
Participant milestones
| Measure |
Treatment (Ramucirumab, Pembrolizumab)
Patients receive ramucirumab IV over 60 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Ramucirumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ramucirumab and Pembrolizumab for the Treatment of EGFR Mutant Recurrent or Metastatic Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Ramucirumab, Pembrolizumab)
n=6 Participants
Patients receive ramucirumab IV over 60 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Ramucirumab: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 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
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsResponse rate will be evaluated with computed tomography (CT) scans every 2 cycles and tumor measurements using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Immune RECIST (iRECIST) will also be assessed.
Outcome measures
| Measure |
Treatment (Ramucirumab, Pembrolizumab)
n=6 Participants
Patients receive ramucirumab IV over 60 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Ramucirumab: Given IV
|
|---|---|
|
Overall Response Rate
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsCommon Terminology Criteria for Adverse Events version 4.0 will be used for adverse event grading. Attributions of causality will be assessed by the primary treating physician. Frequency and severity of adverse events and tolerability of the regimen will be collected and summarized by descriptive statistics for each of the disease cohorts.
Outcome measures
| Measure |
Treatment (Ramucirumab, Pembrolizumab)
n=6 Participants
Patients receive ramucirumab IV over 60 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Ramucirumab: Given IV
|
|---|---|
|
Number of Adverse Events
Lymphocyte count decreased
|
4 Number of Events
|
|
Number of Adverse Events
Activated partial thromboplastin time prolonged
|
4 Number of Events
|
|
Number of Adverse Events
Alanine aminotransferase increased
|
3 Number of Events
|
|
Number of Adverse Events
Alkaline phosphatase increased
|
2 Number of Events
|
|
Number of Adverse Events
Anemia
|
3 Number of Events
|
|
Number of Adverse Events
Anorexia
|
2 Number of Events
|
|
Number of Adverse Events
Arthralgia
|
1 Number of Events
|
|
Number of Adverse Events
Aspartate aminotransferase increased
|
4 Number of Events
|
|
Number of Adverse Events
Cognitive impairment
|
1 Number of Events
|
|
Number of Adverse Events
Constipation
|
2 Number of Events
|
|
Number of Adverse Events
Diarrhea
|
1 Number of Events
|
|
Number of Adverse Events
Dysgeusia
|
3 Number of Events
|
|
Number of Adverse Events
Dysphagia
|
1 Number of Events
|
|
Number of Adverse Events
Dyspnea
|
2 Number of Events
|
|
Number of Adverse Events
Edema limbs
|
3 Number of Events
|
|
Number of Adverse Events
Encephalopathy
|
2 Number of Events
|
|
Number of Adverse Events
Epistaxis
|
1 Number of Events
|
|
Number of Adverse Events
Fall
|
1 Number of Events
|
|
Number of Adverse Events
Fatigue
|
7 Number of Events
|
|
Number of Adverse Events
Generalized muscle weakness
|
1 Number of Events
|
|
Number of Adverse Events
Headache
|
2 Number of Events
|
|
Number of Adverse Events
Hematuria
|
2 Number of Events
|
|
Number of Adverse Events
Hypercalcemia
|
1 Number of Events
|
|
Number of Adverse Events
Hyperglycemia
|
3 Number of Events
|
|
Number of Adverse Events
Hypernatremia
|
1 Number of Events
|
|
Number of Adverse Events
Hypertension
|
4 Number of Events
|
|
Number of Adverse Events
Hyperthyroidism
|
1 Number of Events
|
|
Number of Adverse Events
Hypoalbuminemia
|
5 Number of Events
|
|
Number of Adverse Events
Hypocalcemia
|
1 Number of Events
|
|
Number of Adverse Events
Hypokalemia
|
1 Number of Events
|
|
Number of Adverse Events
Hyponatremia
|
9 Number of Events
|
|
Number of Adverse Events
Hypoxia
|
1 Number of Events
|
|
Number of Adverse Events
Imbalance
|
1 Number of Events
|
|
Number of Adverse Events
Infusion related reaction
|
1 Number of Events
|
|
Number of Adverse Events
INR increased
|
4 Number of Events
|
|
Number of Adverse Events
Bacteriuria
|
1 Number of Events
|
|
Number of Adverse Events
Localized Edema
|
1 Number of Events
|
|
Number of Adverse Events
Mucositis
|
1 Number of Events
|
|
Number of Adverse Events
Myalgia
|
1 Number of Events
|
|
Number of Adverse Events
Nausea
|
1 Number of Events
|
|
Number of Adverse Events
Neuralgia
|
2 Number of Events
|
|
Number of Adverse Events
Osteoporosis
|
1 Number of Events
|
|
Number of Adverse Events
Pericardial effusion
|
1 Number of Events
|
|
Number of Adverse Events
Pleural effusion
|
1 Number of Events
|
|
Number of Adverse Events
Pneumothorax
|
1 Number of Events
|
|
Number of Adverse Events
Productive cough
|
2 Number of Events
|
|
Number of Adverse Events
Proteinuria
|
2 Number of Events
|
|
Number of Adverse Events
Thromboembolic event
|
1 Number of Events
|
|
Number of Adverse Events
Rash maculo-papular
|
2 Number of Events
|
|
Number of Adverse Events
Nephrotic syndrome
|
1 Number of Events
|
|
Number of Adverse Events
Hemoptysis
|
2 Number of Events
|
|
Number of Adverse Events
Sinus tachycardia
|
1 Number of Events
|
|
Number of Adverse Events
Urinary incontinence
|
1 Number of Events
|
|
Number of Adverse Events
Vomiting
|
3 Number of Events
|
|
Number of Adverse Events
Weight gain
|
3 Number of Events
|
|
Number of Adverse Events
Weight loss
|
2 Number of Events
|
|
Number of Adverse Events
Confusion
|
1 Number of Events
|
SECONDARY outcome
Timeframe: Up to 2 yearsClinical benefit rate will be evaluated with CT scans every 2 cycles and tumor measurements using RECIST 1.1 criteria. iRECIST will also be assessed.
Outcome measures
| Measure |
Treatment (Ramucirumab, Pembrolizumab)
n=6 Participants
Patients receive ramucirumab IV over 60 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Ramucirumab: Given IV
|
|---|---|
|
Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease)
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: From the date of study registration to the date of progressive disease, assessed up to 2 yearsKaplan-Meier curves will be calculated to estimate progression-free survival.
Outcome measures
| Measure |
Treatment (Ramucirumab, Pembrolizumab)
n=6 Participants
Patients receive ramucirumab IV over 60 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Ramucirumab: Given IV
|
|---|---|
|
Progression-free Survival
|
1.4 months
Interval 1.13 to
There was insufficient data to determine the upper limit
|
SECONDARY outcome
Timeframe: From the date of study registration to the date of death, assessed up to 2 yearsKaplan-Meier curves will be calculated to estimate overall survival.
Outcome measures
| Measure |
Treatment (Ramucirumab, Pembrolizumab)
n=6 Participants
Patients receive ramucirumab IV over 60 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Ramucirumab: Given IV
|
|---|---|
|
Overall Survival
|
7.03 months
Interval 5.57 to
There was insufficient data to determine the upper limit
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineMeasured by immunohistochemistry, including tumor infiltrating lymphocytes and T cell receptor (TCR) immunosequencing (immunoSEQ) and relationship to clinical outcomes, including response rate. TCR immunoSEQ data will be summarized for each patient for T-cell clonality difference, descriptive statistics and confidence interval will be obtained across patients.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsMeasured using 10-color 65 marker multiplex Clinical Laboratory Improvement Act-certified IMMUNOME flow cytometry profile on peripheral blood samples. For immune cell subpopulation data by flow cytometry, will identify differences between the paired peripheral blood mononuclear cell samples from the same patients.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 2 yearsWill evaluate correlation with clinical response. A bivariate plot will be used to describe the relationship between response rate and peak VEGF via enzyme-linked immunosorbent assay over time.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Ramucirumab, Pembrolizumab)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Treatment (Ramucirumab, Pembrolizumab)
n=6 participants at risk
Patients receive ramucirumab IV over 60 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Ramucirumab: Given IV
|
|---|---|
|
Investigations
Aspartate aminotransferase increase
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Nervous system disorders
Encephalopathy
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for up to 2 years
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Cardiac disorders
Pericardial Effusion
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Vascular disorders
Pulmonary embolism
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Renal and urinary disorders
Nephrotic syndrome
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
Other adverse events
| Measure |
Treatment (Ramucirumab, Pembrolizumab)
n=6 participants at risk
Patients receive ramucirumab IV over 60 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
Ramucirumab: Given IV
|
|---|---|
|
Investigations
Lymphocyte count decreased
|
66.7%
4/6 • Number of events 4 • Adverse event data was collected for up to 2 years
|
|
Investigations
Activated partial thromboplastin time
|
16.7%
1/6 • Number of events 4 • Adverse event data was collected for up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 3 • Adverse event data was collected for up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Number of events 3 • Adverse event data was collected for up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 2 • Adverse event data was collected for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • Number of events 4 • Adverse event data was collected for up to 2 years
|
|
Nervous system disorders
Cognitive disturbance
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Psychiatric disorders
Confusion
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • Number of events 3 • Adverse event data was collected for up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for up to 2 years
|
|
General disorders
Edema limbs
|
50.0%
3/6 • Number of events 3 • Adverse event data was collected for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 7 • Adverse event data was collected for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
3/6 • Number of events 3 • Adverse event data was collected for up to 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Number of events 3 • Adverse event data was collected for up to 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
3/6 • Number of events 5 • Adverse event data was collected for up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
4/6 • Number of events 9 • Adverse event data was collected for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
General disorders
Imbalance
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Investigations
INR (International Normalized Ratio of prothrombin time) Increased
|
33.3%
2/6 • Number of events 4 • Adverse event data was collected for up to 2 years
|
|
Investigations
Bacteriuria
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
General disorders
Localized edema
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Nervous system disorders
Neuralgia
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for up to 2 years
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • Number of events 2 • Adverse event data was collected for up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 2 • Adverse event data was collected for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 3 • Adverse event data was collected for up to 2 years
|
|
Investigations
Weight gain
|
16.7%
1/6 • Number of events 3 • Adverse event data was collected for up to 2 years
|
|
Investigations
Weight loss
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected for up to 2 years
|
Additional Information
Dr. Asrar Alahmadi
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-6786
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place