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PD-L1 Inhibitor
Reduced Chemotherapy + Immunotherapy for Lung Cancer
Richmond, VA
Phase 2
Recruiting
Led By Jonathan Berkman, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (squamous or non-squamous)
Eastern Cooperative Oncology Group (ECOG) PS of 0-3
Must not have
Diagnosis of interstitial lung disease
Creatinine clearance <30 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial will assess how often older adults with advanced lung cancer have to stop their chemotherapy due to side effects when they are treated with a lower dose of chemotherapy along with immunotherapy."
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Who is the study for?
This trial is for older adults with a specific type of lung cancer (NSCLC) that has spread and doesn't have much PD-L1 protein. They should be somewhat fit, not too sick from other diseases, able to understand the study, and haven't had certain treatments before. People who are very ill or have immune system problems can't join.Check my eligibility
What is being tested?
The study tests if giving a smaller dose of chemotherapy along with an immunotherapy drug causes fewer serious side effects in older or frail patients with advanced NSCLC that lacks high levels of PD-L1 protein.See study design
What are the potential side effects?
Possible side effects include reactions to the drugs like fatigue, blood issues, liver problems, and increased risk of infections. The reduced chemo dosage aims to lessen these compared to standard treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed by lab tests to be non-small cell type.
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I can care for myself but may not be able to do heavy physical work.
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My cancer is stage IV or has come back and cannot be cured with treatment.
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My cancer does not have mutations targeted by approved drugs.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with interstitial lung disease.
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My kidney function is low, with a creatinine clearance under 30 mL/min.
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I do not have untreated brain or spinal cord disease causing symptoms.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Occurrence of chemotherapy discontinuation due to treatment-related adverse events
Secondary study objectives
Cancer related symptoms and quality of life
Overall incidence and severity of all adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Overall survival defined as the time from the date of first study treatment until the date of death. Overall survival (OS) will be censored on the last date a participant was known to be alive
+2 moreSide effects data
From 2023 Phase 3 trial • 1460 Patients • NCT0414521958%
Oral pruritus
55%
Throat irritation
33%
Abdominal pain upper
33%
Ear pruritus
25%
Nasopharyngitis
21%
Lip swelling
20%
Glossodynia
19%
Nausea
17%
Taste disorder
14%
Mouth swelling
14%
Swollen tongue
13%
Diarrhoea
13%
Mouth ulceration
9%
Pharyngeal swelling
7%
Tongue ulceration
7%
Vomiting
6%
Tooth loss
5%
COVID-19
5%
Pharyngitis
5%
Bronchitis
3%
Upper respiratory tract infection
2%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
HDM SLIT-tablet (12 SQ-HDM)
Placebo SLIT-tablet
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: Reduced Dose Combination TherapyExperimental Treatment1 Intervention
Squamous cell histology:
1. Carboplatin AUC 3 every 21 days IV for 4 cycles
2. Paclitaxel 135 mg/m2 every 21 IV days for 4 cycles
3. Pembrolizumab 200 mg every 21 days IV until disease progression or unacceptable toxicity up to 35 cycles
Non-squamous histology:
1. Carboplatin AUC 3 every 21 days IV for 4 cycles
2. Pemetrexed 375 mg/m2 every 21 IV days for 4 cycles
3. Pembrolizumab 200 mg every 21 days IV until disease progression or unacceptable toxicity up to 35 cycles
Find a Location
Closest Location:Virginia Commonwealth University· Richmond, VA
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
730 Previous Clinical Trials
22,896,200 Total Patients Enrolled
Jonathan Berkman, MDPrincipal InvestigatorVirginia Commonwealth University