MPDL3280A + Chemoradiation for Lung Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Steven H. Lin | MD Anderson Cancer Center

Overseen BySteven H. Lin, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The goal of this clinical research study is to learn about the safety of adding MDPL3280A to standard chemotherapy (a combination of carboplatin and paclitaxel) and radiation in patients with lung cancer. You are being asked to take part in this study because you have non-small cell lung cancer (NSCLC) that is unresectable (cannot be removed by surgery) and has not spread. This is an investigational study. MPDL3280A is not FDA approved or commercially available. It is currently being used for research purposes only. Paclitaxel, carboplatin, and the radiation therapy are all FDA approved for the treatment of lung cancer. The use of these drugs in combination is considered investigational. Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility Criteria

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.

Inclusion Criteria

My lung cancer is confirmed, untreated, cannot be surgically removed, and requires chemoradiation.

I am 18 years old or older.

Exclusion Criteria

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 have leukemia, lymphoma, or myeloma.

I have a history of certain lung and autoimmune diseases.

I have not had severe infections or sepsis in the last 2 weeks.

My cancer has spread to distant organs like the liver, lung, bone, or brain.

I have active tuberculosis.

I have not received a live vaccine in the last 4 weeks and do not plan to during the study.

Participant Groups

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.

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.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: