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PD-1 Inhibitor

Pembrolizumab for Advanced Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Deborah Doroshow, MD, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients may not have a molecular alteration in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or any other gene for which first-line FDA approved targeted therapy exists

Men and women, aged 18 years and older, with locally advanced NSCLC who are ineligible for definitive surgical resection or concurrent chemoradiation, or metastatic NSCLC

Must not have

Patients with known leptomeningeal disease for which CNS therapy is required

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate the effect of PD-1 therapy on quality of life in advanced NSCLC patients ineligible for curative treatment.

Who is the study for?

Adults with advanced non-small cell lung cancer (NSCLC) who can't have surgery or intense treatment, and haven't had systemic therapy for metastatic cancer. They must have a certain level of tumor protein (PDL-1 TPS ≥ 1%) and be physically able to take part in the study despite having an ECOG performance status of 2 or 3. Participants need functioning organs, controlled HIV if present, no recent brain metastases needing immediate treatment, and agree to use effective contraception.

What is being tested?

The trial is testing Pembrolizumab, an anti PD-1 therapy given intravenously every three weeks to patients with NSCLC. The main goal is to see how it affects quality of life over time using the QLQ-C30 questionnaire. Secondary goals include checking mental health changes and disease response through PET/CT scans following RECIST criteria.

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects such as inflammation in various organs like lungs or intestines, skin reactions, hormone gland problems (like thyroid), fatigue, infusion reactions during administration of the drug, and possibly increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer does not have genetic changes targeted by FDA-approved drugs.

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I am 18 or older with advanced or metastatic non-small cell lung cancer not eligible for surgery or chemoradiation.

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My blood and organ tests show I am healthy enough for the trial.

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I have never been treated with PD-1 or PD-L1 inhibitors.

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I can walk and take care of myself but not able to work.

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I have not had any drug treatments for cancer that has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need treatment for cancer that has spread to the lining of my brain and spinal cord.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I take more than 10mg of prednisone daily for an autoimmune condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 weeks post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 weeks post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in EORTC QLQ-C30 Quality of Life score

Secondary study objectives

Glycation End Products, Advanced

Change in EORTC's QLQ-LC13 Quality of Life (QOL) score

Anxiety

+9 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PembrolizumabExperimental Treatment1 Intervention

Patients will be treated with the standard dose of pembrolizumab (200mg IV every 3 weeks) for the first 12 weeks of the study. After week 12 assessments, patients without objective progression of disease are eligible to transition to Q6W dosing of pembrolizumab 400mg IV.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 9Eligibility criteria met