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Chemotherapy

Pembrolizumab + Chemotherapy for Brain Metastases from Lung Cancer

Phase 2

Waitlist Available

Led By John Villano, MD, PhD

Research Sponsored by John L. Villano, MD, PhD

Eligibility Criteria Checklist

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

Must have

NSLC lacks oncogenic driver mutations

Absence of new onset neurological symptoms

Must not have

Patients with uncontrolled intercurrent illness

Serious non-healing wound, ulcer or bone fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months (baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether the drug Pembrolizumab can help people with NSCLC and untreated brain metastasis live longer with fewer side effects.

Who is the study for?

This trial is for patients with non-small cell lung cancer (NSCLC) who have untreated brain metastases without major symptoms. They should not have more than ten small brain lesions, no serious heart disease or wounds, and must be able to understand the study's consent form. People with certain psychiatric conditions or recent surgeries are excluded.

What is being tested?

The study tests if Pembrolizumab combined with chemotherapy drugs like Carboplatin and Nab-paclitaxel improves survival and life quality in NSCLC patients with brain metastasis while keeping side effects low compared to standard treatments.

What are the potential side effects?

Pembrolizumab may cause immune-related reactions, fatigue, skin issues, infusion reactions, and organ inflammation. Chemotherapy can lead to nausea, hair loss, blood cell count changes increasing infection risk, nerve damage causing numbness or tingling.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer does not have genetic mutations driving its growth.

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I have not experienced any new neurological symptoms.

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I have fewer than 10 brain lesions.

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My lung cancer has spread to my brain but I don't have symptoms.

Exclusion Criteria

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

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I do not have any unmanaged ongoing illnesses.

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I have a serious wound, ulcer, or bone fracture that is not healing.

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I had a minor surgery, like a biopsy, within the last 3 days.

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I have a serious heart condition.

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My cancer has spread to the lining of my brain and spinal cord.

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My cancer has specific genetic changes driving its growth.

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I have had allergic reactions to certain antibody treatments.

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My cancer is near my optic nerve or in my brainstem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months (baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months (baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months (baseline, 3 months post-enrollment, 6 months post-enrollment, 9 months post-enrollment, 12 months post enrollment) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease Control Rate

Secondary study objectives

Change in Extracranial Disease Control

Change in Mild Cognitive Impairment (MoCA)

Change in Patient-reported Cognitive Functioning - Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)

+4 more

Other study objectives

Immune Based Biomarker Activity

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

Clostridium difficile colitis

Systemic infection

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: Pembrolizumab with standard of care chemotherapy treatmentExperimental Treatment5 Interventions

Patients will receive 200mg or 400mg of Pembrolizumab (standard of care dosing at the discretion of treating physician) over thirty minutes on day 1 every three or six weeks with standard of care chemotherapy treatment (carboplatin, pemetrexed, paclitaxel, nab-paclitaxel).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Pemetrexed

2014

Completed Phase 3

~5550