Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I am 18 years old or older.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Toxicity
Secondary outcome measures
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
Paclitaxel
2011
Completed Phase 4
~5380
Radiation Therapy
2017
Completed Phase 3
~7250
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,456 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,039 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has there been any precedent for Radiation Therapy research?
"Right now, there are 1451 clinical trials assessing Radiation Therapy. Of those active studies, 373 have reached Phase 3. 79293 global locations are participating in research related to this therapy with most of the investigations concentrated in Shanghai alone."
Answered by AI
Is this research program currently enrolling participants?
"According to current information on clinicaltrials.gov, this medical trial is not actively recruiting patients. Initially posted on January 26th 2016 and last updated October 31st 2022, the study no longer needs new participants; however, there are 3,625 other trials now seeking enrollees."
Answered by AI
What medical conditions are generally treated with Radiation Therapy?
"Radiation Therapy is commonly used to palliate patients, but it has also been successful in treating malignant peritoneal neoplasms, advanced endometrial cancer, and melanoma."
Answered by AI
What potential risks can be associated with Radiation Therapy?
"As this is a Phase 2 trial, meaning there are indications that Radiation Therapy is safe but not yet effective, our team at Power rated its safety as a 2 on their scale."
Answered by AI
How many participants are currently engaged in this medical experiment?
"Unfortunately, this experiment is not accepting new participants at the moment. The trial was first listed on 26th January 2016 and last updated 31st October 2022. For other clinical trials related to non-small cell lung carcinoma (nsclc), there are currently 2174 enrolments open and 1451 for Radiation Therapy studies in progress which should be considered."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger