Study Summary
The purpose of this study is to test if low dose radiation, which is routinely used in treating patients with lung cancer for symptom control, can improve the results from the standard treatment with pembrolizumab and chemotherapy. In this study, only individuals who have NSCLC that is advanced (Stage IV), or has come back (recurred), will be able to participate.
Eligible Conditions
- Non-Small Cell Lung Cancer (Stage IV)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Up to Week 70 (1 Year following Completion of Treatment Cycle 6)
Week 12
Percent of Participants with a Best Overall Response of Complete Response (CR) or Partial Response (PR) by End of Treatment Cycle 4
Year 1
Duration of Local Control
Overall Survival (OS) at Final Follow-Up
Progression-Free Survival (PFS) at Final Follow-Up
Week 52
Durable Overall Response Rate at Week 52
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Untreated Patients With Stage IV NSCLC
1 of 1
Experimental Treatment
40 Total Participants · 1 Treatment Group
Primary Treatment: Untreated Patients With Stage IV NSCLC · No Placebo Group · Phase 2
Untreated Patients With Stage IV NSCLCExperimental Group · 3 Interventions: Chemotherapy, Radiation, Pembrolizumab · Intervention Types: Drug, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~2740
Radiation
2005
Completed Phase 3
~970
Pembrolizumab
2017
Completed Phase 3
~2240
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 70 (1 year following completion of treatment cycle 6)
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,264 Previous Clinical Trials
753,748 Total Patients Enrolled
Vamsidhar VelchetiPrincipal InvestigatorNYU Langone Health
Eligibility Criteria
Age 18 - 100 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:There must be two different, measurable forms of metastatic disease that measure 1 cm or more; radiation may be used on multiple sites but there should also exist a single un-irradiated target lesion for response assessment.
You are willing to provide archival tissue for correlative studies, or may request an exemption from the research team if no archival tissue is available.
You must be of legal age on the day you provide your informed consent.
Your disease is quantifiable based on the Response Evaluation Criteria in Solid Tumors 1.1 criteria.
You have a performance status of 1 or lower on the ECOG Performance Scale.
You must have adequate functioning organs, as described in Table 2, and all laboratory tests should be done within 10 days of beginning the treatment.
You possess a single lesion, measuring at least 1 cm in size, situated outside the anticipated radiation zone.
Females of childbearing age must present with a negative urine or serum pregnancy test within 72 hours before receiving their initial dose of the study medication
You must be capable of providing written consent/assent for the trial.
You have metastatic Non-Small Cell Lung Cancer (NSCLC) with no prior systemic treatment.
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Conditions
Cancer Related
Treatments