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Monoclonal Antibodies

Anti-PD-L1 Monoclonal Antibody MPDL3280A for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by Karen Kelly
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to up to 30 days after completion of study treatment
Awards & highlights

Study Summary

This trial will test different schedules of anti-PD-L1 monoclonal antibody MPDL3280A and stereotactic ablative radiotherapy in patients with stage IV non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after completion of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after completion of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Progression free survival using RECIST 1.1 and irRECIST
Response rate using irRECIST
Other outcome measures
Changes in biomarkers

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm III (sequential cohort)Experimental Treatment2 Interventions
Patients undergo SAR 2-3 times per week (with a minimum of 40 hours and a maximum of 96 hours between fractions) over 1.5-2 weeks for a total of 5 fractions beginning on day 1 of course 1. After completion of SAR (beginning on day 1 of course 2), patients receive anti-PD-L1 monoclonal antibody MPDL3280A IV over 30-60 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (induction cohort)Experimental Treatment2 Interventions
Patients receive anti-PD-L1 monoclonal antibody MPDL3280A IV over 30-60 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of course 3, patients also undergo SAR 2-3 times per week (with a minimum of 40 hours and a maximum of 96 hours between fractions) over 1.5-2 weeks for a total of 5 fractions.
Group III: Arm I (concurrent cohort)Experimental Treatment2 Interventions
Patients receive anti-PD-L1 monoclonal antibody MPDL3280A IV over 30-60 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of course 1, patients also undergo SAR 2-3 times per week (with a minimum of 40 hours and a maximum of 96 hours between fractions) over 1.5-2 weeks for a total of 5 fractions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,139 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,116 Total Patients Enrolled
Karen KellyLead Sponsor
3 Previous Clinical Trials
59 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Apr 2025