A phase II trial of pembrolizumab in NSCLC PS2 patients
- Conditions
- Specialty: Cancer, Primary sub-specialty: LungUKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organsCancerNon-small cell lung cancer
- Registration Number
- ISRCTN10047797
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32199466 results (added 23/03/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 62
1. Patients must have completed all standard of care therapy that the treating oncologist deems appropriate. All lines of therapy will be allowed
2. Histologically confirmed NSCLC where it is possible to assess PD-L1 status on tumour biopsy. Biopsy must be within 70 days of first treatment with pembrolizumab. All patients who have had systemic therapy since the biopsy must have a repeat biopsy that is evaluable for PD-L1.
3. Patients must have a performance status of 2 on the ECOG Performance scale with no deterioration over the previous 2 weeks assessed by consenting physician
4. Life expectancy >12 weeks
5. Uni-dimensionally measurable disease according to RECIST version 1.1
6. CT scan of chest and abdomen within 28 days of starting Pembrolizumab demonstrating measurable disease as per RECIST version 1.1
7. Demonstrate adequate haematological and organ function as defined below. All screening tests should be performed within 7 days of treatment
8. Age 18 years and over
9. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
10. Patients must agree to the use of contraception as detailed in protocol and patient information sheet
11. System laboratory values:
11.1. Haematological
Absolute neutrophil count = 1.5 x 109/L
Haemoglobin = 90 g/L or =5.6 mmol/L
Platelets = 100 x 109/L
11.2. Hepatic function
Total serum bilirubin = 1.5 x ULN
Alanine transferase (ALT) = 2.5 x ULN.
Aspartate transferase (AST) = 2.5 x ULN.
11.3. Renal function
Creatinine clearance <1.5 times ULN concurrent with creatinine clearance >50 ml/min (calculated by Cockcroft and Gault equation or alternative method). If this is =50 ml/min then an isotopic GFR may be undertaken and must be >50 ml/min.
1. Untreated symptomatic brain or leptomeningeal metastatic disease
2. Medical or psychiatric conditions comprising informed consent
3. Any medical condition which in the opinion of the investigator would compromise the ability of the patient to participate in the trial or which would jeopardise compliance with the protocol
4. Patient who has had chemotherapy, radioactive or biological cancer therapy within 4 weeks prior to the first dose of study therapy, or who has not recovered to CTCAE grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks earlier. Patient who has had erlotinib, gefitinib, afatinib, or crizotinib within 1 week prior to the first dose of study therapy, or who has not recovered to CTCAE Grade 1 or better from the adverse events due to any of these drugs administered more than 1 week earlier. Patient who has had ipilimumab therapy may be enrolled if requirements specified in Inclusion Criterion are met.
5. Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
6. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
7. Patient has risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra-abdominal abscess and abdominal carcinomatosis)
8. Patient has a known history of malignancy, unless the patient has undergone potentially curative therapy with no evidence of that disease for 5 years
9. Previous history of pneumonitis or significantly reduced transfer coefficient (KCO)
10. Female patients of child bearing potential should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing
11. Patient previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody
12. Patient had prior treatment targeting PD-1: PD-L1 axis or was previously randomized in any Pembrolizumab trial
13. Patient is positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA (qualitative) is detected); patients with negative Hepatitis C antibody testing may not need RNA testing
14. Known history of tuberculosis
15. Patient has an active infection requiring therapy
16. Has received a live vaccine within 30 days prior to the first dose of trial treatment
17. Patient is, at the time of signing informed consent, a regular user (including recreational use”) of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol)
18. Patients with symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method