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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Biomarker response

Overall survival

Progression free survival

+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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

~6670

Cisplatin

2013

Completed Phase 3

~1940

Etoposide

2010

Completed Phase 3

~2440

Pembrolizumab

2017

Completed Phase 2

~2010

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,584 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,719 Total Patients Enrolled

James WelshPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

357 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are being monitored in this trial?

"At this moment, no further participants are being sought for the study in question. It was originally posted on July 22nd 2015 and last edited on February 2nd 2022. Should you be looking for other trials, 3983 clinical studies concerning carcinoma and 2118 involving Pembrolizumab require individuals to participate."

Answered by AI

Are there still slots available in this clinical trial for participants?

"According to the information published on clinicaltrials.gov, this medical study is not actively enrolling participants at the present moment. The trial was first made available on July 22nd 2015 and last edited February 2nd 2022. Despite this particular trial being closed off from new candidates, there are 6,101 other studies that remain open for enrollment as of now."

Answered by AI

What goals is this clinical experiment attempting to accomplish?

"The primary endpoint for this trial, which will be evaluated over a time period of up to 22 days after the commencement of treatment, is the maximum tolerated dose of pembrolizumab and concurrent chemoradiation determined by toxicity levels assessed in accordance with the National Cancer Institute Common Terminology Criteria. Secondary endpoints include biomarker response (via global patient outcomes assessment), response rate (Global Immune Related Response Criteria that accounts for indexed and non-indexed lesions), In-Field Immune related Response Criteria (non-radiotherapy treated lesions outside RT planning target volume) Out-Field Immune Related Response criteria"

Answered by AI

What applications of Pembrolizumab are typically seen in the medical field?

"Pembrolizumab is an approved intervention for a variety of pathologies, including Hodgkin's Disease, metastatic cutaneous squamous cell carcinoma, and refractory testicular cancer."

Answered by AI