Clinical trial · Interventional
Pembrolizumab in Patients With Non-Small Cell Lung Cancer and a Performance Status 2
A Phase II Trial of Pembrolizumab in Patients With Non-small Cell Lung Cancer and a Performance Status of 2
NCT02733159CI-TRIAL-00085689PePS2completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pembrolizumab
- description
- Pembrolizumab: 200 mg Q3W, intravenous administration for a maximum of 2 years, or until progression or unacceptable toxicity.
- interventionNames
- Drug: pembrolizumab
Primary outcomes (2)
- measure
- Toxicity Rate
- timeFrame
- Date of patient registration until 6 months after the administration of the last treatment (a maximum of 2 years treatment and 6 months followup after end of treatment)
- description
- Adverse events will be recorded in relation to each cycle of treatment and graded according to CTCAE criteria. The toxicity co-primary outcome measure for the trial is defined as the occurrence of a treatment-related dose delay or treatment discontinuation due to toxicity.
- measure
- Durable Clinical Benefit
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Core Inclusion Criteria: * Histologically confirmed PD-L1 status defined NSCLC. Biopsy must be within 70 days of first treatment with pembrolizumab. * Eastern Cooperative Oncology Group (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.
References
Publications (1)
- RESULTMiddleton G, Brock K, Savage J, Mant R, Summers Y, Connibear J, Shah R, Ottensmeier C, Shaw P, Lee SM, Popat S, Barrie C, Barone G, Billingham L. Pembrolizumab in patients with non-small-cell lung cancer of performance status 2 (PePS2): a single arm, phase 2 trial. Lancet Respir Med. 2020 Sep;8(9):895-904. doi: 10.1016/S2213-2600(20)30033-3. Epub 2020 Mar 19. PMID 32199466