A Phase III, Open-Label, Randomized Study of MPDL3280A (Anti-PDL1 Antibody) Compared with Cisplatin or Carboplatin + Pemetrexed for PD-L1-Selected Chemotherapy Naive Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer

SUMMARY

The purpose of this study is to look at the effects, good or bad, of MPDL3280A on you and your non-small cell lung cancer (NSCLC). MPDL3280A is an experimental drug, which means that that it is currently being tested and has not been approved by the FDA for the treatment of NSCLC. You were selected as a possible participant in this study because you have NSCLC that has spread to areas near your lungs or other organs and has not yet been treated by chemotherapy.

MPDL3280A is an antibody (a large, Y-shaped protein used by your body's immune system to identify and neutralize foreign objects such as bacteria, viruses, and tumor cells) that affects your immune system by blocking the PD-L1 pathway. The PD-L1 pathway is involved in decreasing your body’s natural immune response to fight cancer.  By blocking the PD-L1 pathway, MPDL3280A may help your immune system stop or reverse the growth of tumors. 

 

Data obtained from an earlier study in patients with NSCLC showed that patients who had the PD-L1 biomarker may do better and have their tumors shrink when treated with MPDL3280A.

 

People with lung cancer who have the PD-L1 biomarker may participate in Study GO29431.

 

Your voluntary participation in this research study may help to determine whether MPDL3280A is safe and effective when given to patients with advanced NSCLC.

 

Blood, tissue samples, and related medical information collected during this study will be used by the Sponsor researchers and other researchers partnering with the Sponsor to learn more about how MDPL3280A works in NSCLC.

COH Protocol Number : 15059

ClinicalTrials.gov Number : NCT02409342

Principal Investigator : Koczywas, Marianna M.D.

Sponsor : F. Hoffmann-La Roche Ltd.

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : >=18

Gender : Either

Minimum Performance Status : ECOG/SWOG:0

Treatment Intent : Non-Adjuvant treatment

Prior Chemotherapy :

Brain Metastases :

Measurable Disease :