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Pembrolizumab + Chemotherapy + Radiation for Lung Cancer

Phase 1

Waitlist Available

Led By Salma Jabbour, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

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

Must have

Serum creatinine OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance rate [CrCl]) =< 1.5 X upper limit of normal (ULN) OR >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN

Must have American Joint Committee on Cancer (AJCC) 7th edition (ed) inoperable stage II disease requiring chemoradiation therapy or stage IIIA or IIIB NSCLC based on appropriate staging studies including brain magnetic resonance imaging (MRI) or head computed tomography (CT), CT chest, and fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT scan

Must not have

Has received a live vaccine within 30 days of planned start of study therapy

Has known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (HCV) (e.g., HCV ribonucleic acid [RNA] [qualitative] is detected)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time of initiation of chemoradiation through study completion (death)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing pembrolizumab given with paclitaxel, carboplatin, and radiation therapy to treat stage II-IIIB non-small cell lung cancer to learn the best dose and way to give it, and to find out what side effects it causes.

Who is the study for?

This trial is for adults with stage II-IIIB non-small cell lung cancer who haven't had prior treatments that conflict with the study. They must have good organ function, no active infections or autoimmune diseases, not be pregnant or breastfeeding, and agree to use contraception. People with certain medical conditions or those who've received specific treatments recently are excluded.

What is being tested?

The trial tests pembrolizumab (an antibody therapy) combined with chemotherapy drugs paclitaxel and carboplatin, alongside radiation therapy. It aims to find the safest doses and how well they work together in treating patients by stopping tumor growth and spread.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells, infusion-related reactions from the drug entering the body, fatigue, blood disorders like low platelet counts or anemia, liver enzyme changes indicating potential liver damage, kidney function changes, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function, measured by creatinine or GFR, is within the normal range.

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My lung cancer is at a stage that cannot be surgically removed and requires combined chemotherapy and radiation.

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My lung function test shows I can breathe out at least 1.0 L or 40% of what's expected.

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My lung cancer type was confirmed not just by sputum tests.

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My liver function tests are within the required range.

Exclusion Criteria

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

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I have not received a live vaccine in the last 30 days.

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I have active hepatitis B or C.

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My pleural effusion cannot be managed despite treatments.

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I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.

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I have been diagnosed with HIV.

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I do not have active brain metastases or carcinomatous meningitis.

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I do not have any other ongoing cancers.

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I haven't had cancer treatment in the last 2 weeks or have recovered from its side effects.

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I have been treated with drugs targeting PD-1 or PD-L1 before.

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I am currently being treated for an infection.

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I have or had lung inflammation not caused by an infection.

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I have an active TB infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time of initiation of chemoradiation through study completion (death)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time of initiation of chemoradiation through study completion (death)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time of initiation of chemoradiation through study completion (death) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of the Combination of Pembrolizumab With Paclitaxel, Carboplatin and Radiation Therapy According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Secondary study objectives

Best Overall Response According to Response Evaluation Criteria in Solid Tumors RECIST 1.1

Immune-related Response Evaluation Criteria In Solid Tumors Using Immune-Related Response (irRC).

Metastasis-free Survival as Measured by the Kaplan Meier Estimation Method

+2 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

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: Treatment (paclitaxel, carboplatin, radiation, pembrolizumab)Experimental Treatment6 Interventions

Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients undergo 3D CRT or IMRT QD 5 days a week for 6 weeks. Beginning 2-6 weeks after, 2 weeks before the end, or at the start of chemotherapy and radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160