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Ramucirumab and Pembrolizumab for the Treatment of EGFR Mutant Recurrent or Metastatic Non-small Cell Lung Cancer
Phase 2 trial testing Pembrolizumab in Metastatic Lung Non-Small Cell Carcinoma in 6 participants. Completed in 19 August 2023.
| Lead sponsor | Ohio State University Comprehensive Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 17 June 2020 |
| Primary completion | 19 August 2023 |
| Estimated completion | 19 August 2023 |
| Sites | 1 location across United States |
Ohio State University Comprehensive Cancer Center
18 and older, any sex, with Metastatic Lung Non-Small Cell Carcinoma or Recurrent Lung Non-Small Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ramucirumab, Pembrolizumab) | 0 |
Common 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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ramucirumab, Pembrolizumab) | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ramucirumab, Pembrolizumab) | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ramucirumab, Pembrolizumab) | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ramucirumab, Pembrolizumab) | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ramucirumab, Pembrolizumab) | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ramucirumab, Pembrolizumab) | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ramucirumab, Pembrolizumab) | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ramucirumab, Pembrolizumab) | 4 |
Clinical benefit rate will be evaluated with CT scans every 2 cycles and tumor measurements using RECIST 1.1 criteria. iRECIST will also be assessed.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ramucirumab, Pembrolizumab) | 50 |
Kaplan-Meier curves will be calculated to estimate progression-free survival.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ramucirumab, Pembrolizumab) | 1.4 | 1.13 – NA |
Kaplan-Meier curves will be calculated to estimate overall survival.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ramucirumab, Pembrolizumab) | 7.03 | 5.57 – NA |
Time frame: Adverse event data was collected for up to 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Ramucirumab, Pe… |
|---|---|---|
| Encephalopathy | Nervous system disorders | — |
| Aspartate aminotransferase increase | Investigations | — |
| Hypertension | Vascular disorders | — |
| Pericardial Effusion | Cardiac disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Pulmonary embolism | Vascular disorders | — |
| Nephrotic syndrome | Renal and urinary disorders | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Treatment (Ramucirumab, Pe… |
|---|---|---|
| Lymphocyte count decreased | Investigations | — |
| Fatigue | General disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Edema limbs | General disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Alkaline phosphatase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Dysgeusia | Nervous system disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Headache | Nervous system disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Hypertension | Vascular disorders | — |
| INR (International Normalized Ratio of prothrombin time) Increased | Investigations | — |
| Neuralgia | Nervous system disorders | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Weight loss | Investigations | — |
| Activated partial thromboplastin time | Investigations | — |
| Alanine aminotransferase increased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Cognitive disturbance | Nervous system disorders | — |
| Confusion | Psychiatric disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| Hypercalcemia | Metabolism and nutrition disorders | — |
| Hypernatremia | Metabolism and nutrition disorders | — |
| Hyperthyroidism | Endocrine disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Imbalance | General disorders | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — |
Most-reported serious reactions: Encephalopathy, Aspartate aminotransferase increase, Hypertension, Pericardial Effusion, Pleural effusion, Pulmonary embolism, Nephrotic syndrome, Pneumothorax.
Data from ClinicalTrials.gov NCT04120454 adverse events section.
This phase II trial studies how well ramucirumab and pembrolizumab work in treating EGFR mutant non-small cell lung cancer that has come back (recurrent) or spread to other places in the body (metastatic) while on systemic therapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab, a drug which has anti-angiogenic and pleotropic immunomodulatory effects and may synergize with the effect of an anti-PD-1 agent. The study investigates the effect of targeted anti-antitumor activity of immune checkpoint inhibitor pembrolizumab and immune-suppressive activity of VEGF-inhibitor ramicirumab to evaluate the efficacy and the tolerability of the combination.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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