Pembrolizumab in Patients With Non-Small Cell Lung Cancer and a Performance Status 2

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to determine that pembrolizumab is safe and tolerable at the selected dose for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients with a performance status of

2. All patients will receive pembrolizumab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Birmingham
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Pembrolizumab

Criteria

Core Inclusion Criteria:

• Histologically confirmed PD-L1 status defined NSCLC. Biopsy must be within 70 days of first treatment with pembrolizumab.

• ECOG performance status 2.

• Life expectancy > 12 weeks.

• Uni-dimensionally measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

• Computerised Tomography (CT) scan of chest and abdomen within 28 days of starting pembrolizumab.

• Adequate haematological function:

• Platelet count ≥100 x 109 /L.

• Neutrophils ≥1.5 x 109/L.

• Haemoglobin ≥ 90 g/L.

• Adequate hepatic function:

• Serum bilirubin ≤1.5 x upper limit of normal (ULN).

• Serum transaminases ≤2.5 x ULN.

• Adequate renal function: Creatinine clearance <1.5 times ULN concurrent with creatinine clearance >50 ml/min.

• Provision of signed and dated, written informed consent prior to any trial specific procedures, sampling and analyses.

Core Exclusion Criteria:

• Patients who do not meet the criteria of performance status = 2 on the ECOG Performance scale.

• Untreated symptomatic brain or leptomeningeal metastatic disease.

• Medical or psychiatric conditions compromising informed consent.

• 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.

• Radiotherapy within 28 days of trial treatment.

• Active autoimmune disease that has required systemic treatment in past 2 years

• Chronic usage of steroids or other immunosuppressant medication.

• Previous history of pneumonitis.

• Any evidence of clinical autoimmunity.