Clinical trial NCT02525757: MPDL3280A With Chemoradiation for Lung Cancer
Official title: DETERRED: PD-L1 blockadE To Evaluate the Safety of Lung CanceR Therapy Using Carboplatin, Paclitaxel, and Radiation CombinEd With MPDL3280A
Conditions: Lung Cancer
Non-Small Cell Lung Cancer
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.
Interventions:
description: 1200 mg by vein every 3 weeks up to 1 year after completing consolidation chemotherapy.<br/>Group 1: MPDL3280A given after receiving standard chemotherapy and radiation for 6-7 weeks, followed by a 3-4 week rest period.<br/>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.
name: MPDL3280A
type: Drug
description: 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.
name: Carboplatin
other_name: Paraplatin
type: Drug
description: 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.
name: Paclitaxel
other_name: Taxol
type: Drug
description: 60-66 Gy in 30-33 fractions administered once-daily on Day 1, 5 days a week, for 6 to 7 weeks.
name: Radiation Therapy
other_name: XRT
type: Radiation
Study arms:
design_group_description: 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.<br/>Consolidation Phase: After the rest period, participants receive MPDL3280A in addition to chemotherapy for 2 cycles.<br/>Maintenance Phase: After completing the consolidation period, participants continue to receive MPDL3280A alone for up to 1 year.
design_group_title: Group 1: Chemotherapy + Radiation
design_group_type: Experimental
design_group_description: 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.<br/>Consolidation Phase: After the rest period, participants receive MPDL3280A in addition to chemotherapy for 2 cycles.<br/>Maintenance Phase: After completing the consolidation period, participants continue to receive MPDL3280A alone for up to 1 year.
design_group_title: Group 2: MPDL3280A + Chemotherapy + Radiation
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: Genentech, Inc.
Drug name mappings:
name: 卡铂
lang: CN
name: Carboplatin
lang: EN
name: カルボプラチン
lang: JP
name: 紫杉醇
lang: CN
name: Paclitaxel
lang: EN
name: パクリタキセル
lang: JP
name: 阿替利珠单抗
lang: CN
name: Atezolizumab
lang: EN
name: アテゾリズマブ（遺伝子組換え）
lang: JP