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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 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
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
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
Etoposide
2010
Completed Phase 3
~2960
Pembrolizumab
2017
Completed Phase 3
~2810
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,887 Previous Clinical Trials
41,020,945 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,054 Previous Clinical Trials
1,798,801 Total Patients Enrolled
James WelshPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
437 Total Patients Enrolled
~6 spots leftby Jul 2025
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