MPDL3280A With Chemoradiation for Lung Cancer
NCT02525757 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2026-02-04
Summary
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.
Conditions
Interventions
- DRUG
-
MPDL3280A
1200 mg by vein every 3 weeks up to 1 year after completing consolidation chemotherapy. Group 1: MPDL3280A given after receiving standard chemotherapy and radiation for 6-7 weeks, followed by a 3-4 week rest period. Group 2: MPDL3280A given with standard chemotherapy, and radiation therapy for 6-7 weeks followed by a rest period of 3-4 weeks, during which time participants receive 1 dose of MPDL3280A but no chemotherapy or radiation.
- DRUG
-
AUC 2 by vein once a week on Day 1 during radiation therapy. During consolidation chemotherapy, Carboplatin given at AUC 6 by vein on Days 1 and 22 for 2 cycles.
- DRUG
-
50 mg/m2 by vein once a week on Day 1 during radiation therapy. During consolidation chemotherapy, Paclitaxel given at 200 mg/m2 on Days 1 and 22 for 2 cycles.
- RADIATION
-
Radiation Therapy
60-66 Gy in 30-33 fractions administered once-daily on Day 1, 5 days a week, for 6 to 7 weeks.
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Steven H. Lin, MD, PHD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-26
- Primary Completion
- 2028-01-31
- Completion
- 2028-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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