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Platinum-containing Compound

Pembrolizumab + Chemoradiotherapy/Radiation for Small Cell Lung Cancer

Phase 1

Waitlist Available

Led By James Welsh

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Have a performance status of 0 or 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) performance scale

Female subjects of childbearing potential should have a negative pregnancy test and be willing to use birth control

Must not have

Received prior therapy with specific immunotherapy agents

Known history of human immunodeficiency virus (HIV) or active hepatitis B or C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of pembrolizumab when given with chemoradiotherapy or radiation therapy for small cell lung cancer.

Who is the study for?

This trial is for adults with small cell lung cancer or neuroendocrine tumors who are in good physical condition (ECOG 0-2), have adequate organ function, and can consent to the study. Women of childbearing age must test negative for pregnancy and agree to birth control; men must also agree to use contraception. Exclusions include HIV, hepatitis B/C, recent immunosuppressive treatments, other active cancers, CNS metastases, severe autoimmune diseases, lung disease like pneumonitis, live vaccines within 30 days before treatment start.

What is being tested?

The trial tests how safe pembrolizumab is when combined with chemoradiotherapy or radiation therapy alone in treating small cell lung cancer. Pembrolizumab is an immunotherapy drug that may boost the immune system's response against cancer cells. The combination aims to see if it improves outcomes compared to standard chemotherapy and radiation therapy.

What are the potential side effects?

Pembrolizumab might cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver issues (hepatitis), skin reactions (rash), digestive tract problems (colitis) and hormonal gland problems (thyroid disorders). Chemotherapy can lead to fatigue, nausea/vomiting, low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

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I am not pregnant and agree to use birth control.

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My cancer is a type of small cell lung cancer or neuroendocrine tumor.

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My kidney function, based on tests, is 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 received treatment with specific immune-boosting drugs.

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I have a known history of HIV or active hepatitis B or C.

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I haven't had chemotherapy or targeted therapy in the last 2 weeks and have recovered from any side effects.

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I have another cancer that is getting worse or needs treatment.

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I have a lung condition not caused by an infection.

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I am currently on medication for an infection.

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I haven't taken steroids or immunosuppressants in the last 7 days.

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I have an autoimmune disease that needed treatment in the last 3 months.

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I have active brain metastases or cancer in the lining of my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years 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 of pembrolizumab with concurrent chemoradiation determined by dose limiting toxicities graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Part A)

Maximum tolerated dose of pembrolizumab with concurrent radiation determined by dose limiting toxicities graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Part B)

Secondary study objectives

Biomarker response

Overall survival

Progression free survival

+1 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

2Treatment groups

Experimental Treatment

Group I: Part B (ES-SCLC, pembrolizumab, radiation therapy)Experimental Treatment3 Interventions

Beginning after the completion of chemotherapy, patients receive pembrolizumab IV over 30 minutes on day 1 and undergo radiation therapy BID 5 days a week for 3 weeks. Treatment repeats every 3 weeks for 16 courses (1 course for radiation therapy) in the absence of disease progression or unacceptable toxicity.

Group II: Part A (LS-SCLC, pembrolizumab, chemoradiotherapy)Experimental Treatment6 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1 and undergo radiation therapy BID 5 days a week for 3 weeks. Patients also receive cisplatin IV over 2 hours or carboplatin IV over 30 minutes and etoposide IV over 4 hours on days 1, 2, and 3. Treatment repeats every 3 weeks for 16 courses (1 course for radiation therapy, 4 courses for chemotherapy) in the absence of disease progression or unacceptable toxicity. Patients who achieve systemic disease control and do not exhibit severe (grade \> 3) pembrolizumab related toxicity during/after completion of 16 courses may receive 16 additional courses of pembrolizumab in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Cisplatin

2013

Completed Phase 3

~3120