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Alkylating agents
MPDL3280A + Chemoradiation for Lung Cancer
Phase 2
Waitlist Available
Led By Steven H. Lin, MD, PHD
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
Patients must have histologically confirmed, untreated non-small cell lung cancer that are considered non-metastatic, unresectable for which chemoradiation is the definitive therapy
Age >/= 18 years
Must not have
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
Major surgical procedure within 28 days prior to treatment start or anticipation of need for a major surgical procedure during the course of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 1 year
Awards & highlights
Summary
This trial is studying if adding MPDL3280A to standard chemotherapy and radiation is safe for patients with non-small cell lung cancer.
Who is the study for?
This trial is for adults with non-small cell lung cancer that can't be removed by surgery and hasn't spread. Participants must have good organ function, agree to use contraception if they can have children, and be willing to follow the study rules. People with severe allergies, certain other cancers or diseases, recent treatments or surgeries, infections like HIV/hepatitis B/C, or who are pregnant/breastfeeding cannot join.
What is being tested?
The trial tests adding MPDL3280A (not yet FDA approved) to standard chemo (carboplatin and paclitaxel) plus radiation therapy in treating lung cancer. The combination's safety is being studied in up to 40 participants at MD Anderson Cancer Center.
What are the potential side effects?
Possible side effects include allergic reactions related to MPDL3280A or chemotherapy drugs used in the treatment regimen. Since this is investigational research, there may also be unknown risks associated with combining these therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed, untreated, cannot be surgically removed, and requires chemoradiation.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a significant liver condition, such as hepatitis or cirrhosis.
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I haven't had major surgery in the last 28 days and don't expect to need one during the study.
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I have leukemia, lymphoma, or myeloma.
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I have a history of certain lung and autoimmune diseases.
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I have not had severe infections or sepsis in the last 2 weeks.
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My cancer has spread to distant organs like the liver, lung, bone, or brain.
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I have active tuberculosis.
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I have not received a live vaccine in the last 4 weeks and do not plan to during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months and 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months and 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to Toxicity
Secondary study objectives
Progression Free Survival (PFS)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2: MPDL3280A + Chemotherapy + RadiationExperimental Treatment4 Interventions
Participants receive MPDL3280A, standard chemotherapy, and radiation therapy for 6-7 weeks. This will be followed by a rest period of 3-4 weeks, during which time participant receives 1 dose of MPDL3280A but no chemotherapy or radiation.
Consolidation Phase: After the rest period, participants receive MPDL3280A in addition to chemotherapy for 2 cycles.
Maintenance Phase: After completing the consolidation period, participants continue to receive MPDL3280A alone for up to 1 year.
Group II: Group 1: Chemotherapy + RadiationExperimental Treatment4 Interventions
Participants receive standard chemotherapy and radiation for 6-7 weeks, followed by a 3-4 week rest period when they receive no chemotherapy or radiation.
Consolidation Phase: After the rest period, participants receive MPDL3280A in addition to chemotherapy for 2 cycles.
Maintenance Phase: After completing the consolidation period, participants continue to receive MPDL3280A alone for up to 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MPDL3280A
2016
Completed Phase 3
~330
Carboplatin
2014
Completed Phase 3
~6120
Paclitaxel
2011
Completed Phase 4
~5810
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,649 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,550 Previous Clinical Trials
568,312 Total Patients Enrolled
Steven H. Lin, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
94 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had severe infections in the last 4 weeks.I have a significant liver condition, such as hepatitis or cirrhosis.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I haven't had any cancers in the last 3 years, except for certain types.My blood clotting tests are within normal limits, and I'm not on strong blood thinners.I have leukemia, lymphoma, or myeloma.You have a history or risk of autoimmune disease, with some specific exceptions.I have a history of certain lung and autoimmune diseases.I have not had severe infections or sepsis in the last 2 weeks.You have had a bone marrow or solid organ transplant from someone else in the past.I agree to a biopsy if my existing cancer samples are not enough.My lung cancer is confirmed, untreated, cannot be surgically removed, and requires chemoradiation.My cancer has spread to distant organs like the liver, lung, bone, or brain.I have a history of specific infections, metabolic issues, or clinical findings.I have active tuberculosis.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I haven't taken certain medications before starting chemoradiation.I am 18 years old or older.I can care for myself and am eligible for chemotherapy with radiotherapy.I have HIV or active hepatitis B/C, with some exceptions.You have a tumor that can be measured using specific guidelines for evaluating treatment response.I can provide a tumor sample from a biopsy with the pathology report.My recent blood and organ tests meet the study's requirements.I haven't had cancer treatment in the last 3 weeks, with some exceptions.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: Chemotherapy + Radiation
- Group 2: Group 2: MPDL3280A + Chemotherapy + Radiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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