18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Toxicity RatePrimary· 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)
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.
Patients Experiencing Toxicity Event
Group
Value
95% CI
Pembrolizumab
18
Patients Not Experiencing Toxicity Event
Group
Value
95% CI
Pembrolizumab
42
Durable Clinical BenefitPrimary· ≥18 weeks, up to maximum of 2 years
Patients will have CT scans every 9 weeks from baseline until disease progression. On each occasion, overall tumour burden will be assessed using RECIST version 1.1. The efficacy co-primary outcome measure for the trial is durable clinical benefit defined as the occurrence of CR, PR or SD without prior progressive disease at or after the second scheduled CT scan (scheduled to occur at 18 weeks).
Group
Value
95% CI
Pembrolizumab
22
Pembrolizumab
38
Objective ResponseSecondary· ≥18 weeks, up to maximum of 2 years
Objective response (OR) is the occurrence of Complete Response (CR) or Partial Response (PR) as the best overall response. OR will be based on responses confirmed using the subsequent 9-weekly scan but OR based on unconfirmed responses will also be reported.
Group
Value
95% CI
Pembrolizumab
44
Pembrolizumab
16
Time to ProgressionSecondary· Time to progression up to 2 years
This is defined as the time from commencement of trial treatment to the date of CT scan when progressive disease first recorded. Patients with no recorded progression at the time of analysis or who die without recorded progression will be censored at the date of the CT scan when they were last recorded with an evaluable measure that was not progression.
Group
Value
95% CI
Pembrolizumab
11.9
4.13 – 27.8
Progression-free Survival TimeSecondary· Progression-free survival time up to 2 years
This is defined as the time from commencement of trial treatment to the date of CT scan when progressive disease first recorded or date of death without previously recorded progression. Patients who are alive with no recorded progression at the time of analysis will be censored at the date of the CT scan when they were last recorded with an evaluable measure that was not progression.
Group
Value
95% CI
Pembrolizumab
4.39
3.48 – 9.9
Overall Survival TimeSecondary· Survival time up to 2 years or date of death
This is defined as the time from commencement of trial treatment to the date of death. Patients who are alive at the time of analysis will be censored at the date last seen alive.
Group
Value
95% CI
Pembrolizumab
9.8
6.77 – 13
Duration of Objective ResponseSecondary· Survival time up to 2 years or date of death
This is defined as the time from commencement of trial treatment to the date of the subsequent CT scan when progressive disease is first confirmed or date of death without previously recorded progression. This outcome is calculated and reported separately for patients who achieve an Objective Response (OR) or Stable Disease (SD). Patients experiencing OR or SD who are alive with no recorded progression at the time of analysis will be censored at the date of the CT scan when they were last recorded with an evaluable measure that was not progression.
Group
Value
95% CI
Pembrolizumab
14.6
12.1 – NA
Duration of Stable DiseaseSecondary· Survival time up to 2 years or date of death
This is defined as the time from commencement of trial treatment to the date of the subsequent CT scan when progressive disease is first confirmed or date of death without previously recorded progression. This outcome is calculated and reported separately for patients who achieve an Objective Response (OR) or Stable Disease (SD). Patients experiencing OR or SD who are alive with no recorded progression at the time of analysis will be censored at the date of the CT scan when they were last recorded with an evaluable measure that was not progression.
Group
Value
95% CI
Pembrolizumab
4.39
3.97 – 6.77
Adverse events — posted to ClinicalTrials.gov
Time frame: 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).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Pembrolizumab
Serious: 51/60 (85%)
Deaths: 48/60
Serious adverse events (48 terms)
Reaction
System
Pembrolizumab
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Other - Death
Respiratory, thoracic and mediastinal disorders
—
General disorders
—
Diarrhea
Gastrointestinal disorders
—
Other - Death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Back pain
Musculoskeletal and connective tissue disorders
—
Anorexia
Metabolism and nutrition disorders
—
Fever
General disorders
—
Lung infection
Infections and infestations
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
Other - Shortness of Breath
Respiratory, thoracic and mediastinal disorders
—
Confusion
Psychiatric disorders
—
Hypercalcemia
Metabolism and nutrition disorders
—
Stroke
Nervous system disorders
—
Vestibular disorder
Ear and labyrinth disorders
—
Acute kidney injury
Renal and urinary disorders
—
Adrenal insufficiency
Endocrine disorders
—
Alanine aminotransferase increased
Investigations
—
Ataxia
Nervous system disorders
—
Atrial fibrillation
Cardiac disorders
—
Cardiac arrest
Cardiac disorders
—
Other - Death
Cardiac disorders
—
Dizziness
Nervous system disorders
—
Other adverse events (240 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy
· Phase 2
· recruiting
NCT06899126 — Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-sm
· Phase 3
· recruiting
NCT06161545 — Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcino
· Phase 2
· recruiting
NCT05879484 — Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic Squamous Cell Ca
· Phase 1, PHASE2
· withdrawn
NCT06682806 — A Study of PRT3789 in Combination With Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4
· Phase 2
· terminated
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Birmingham
Last refreshed: 10 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02733159.