Spots Global Cancer Trial Database for Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib
Official Title: A Phase II Study Assessing the Efficacy of Osimertinib in Combination With Savolitinib in Patients With EGFRm+ and MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer Who Have Progressed Following Treatment With Osimertinib.
Study ID: NCT03778229
Conditions
Study Description
Brief Summary: This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib
Detailed Description: The combination of osimertinib with savolitinib in this study (the SAVANNAH study) will explore if the combination will overcome MET-amplification as a mechanism of resistance. The SAVANNAH study will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET-amplified/overexpressed, locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib. Eligible patients will be those with histologically or cytologically confirmed diagnosis of EGFRm+, MET amplified/overexpressed (FISH10+ and/or IHC90+) NSCLC that is locally advanced or metastatic and is not amenable to further surgery or radiotherapy with curative intent. The disease must have progressed following treatment with first line osimertinib. Patients must have confirmation of MET-amplified/overexpressed tumour by central FISH and IHC testing (requirements summarised in the main body of the protocol and fully explained in the Central Laboratory Manual). Patients must not have received prior or current treatment with savolitinib or another MET inhibitor. All patients confirmed as eligible will begin treatment on Day 1 with osimertinib + savolitinib combination therapy or placebo to osimertinib + savolitinib. Treatment will continue in 28 day cycles until either objective disease progression by investigator per RECIST 1.1 is assessed, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, La Jolla, California, United States
Research Site, Los Angeles, California, United States
Research Site, Sacramento, California, United States
Research Site, Santa Rosa, California, United States
Research Site, New Haven, Connecticut, United States
Research Site, Washington, District of Columbia, United States
Research Site, Boca Raton, Florida, United States
Research Site, Baltimore, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Boston, Massachusetts, United States
Research Site, Boston, Massachusetts, United States
Research Site, Rochester, Minnesota, United States
Research Site, Brooklyn, New York, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Seattle, Washington, United States
Research Site, Barretos, , Brazil
Research Site, Curitiba, , Brazil
Research Site, Goiania, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Rio de Janeiro, , Brazil
Research Site, Salvador, , Brazil
Research Site, Sao Paulo, , Brazil
Research Site, São José do Rio Preto, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Calgary, Alberta, Canada
Research Site, Edmonton, Alberta, Canada
Research Site, Newmarket, Ontario, Canada
Research Site, North York, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Herlev, , Denmark
Research Site, København Ø, , Denmark
Research Site, Næstved, , Denmark
Research Site, Odense C, , Denmark
Research Site, Vejle, , Denmark
Research Site, Ålborg, , Denmark
Research Site, Dijon, , France
Research Site, Marseille Cedex 20, , France
Research Site, Nantes, , France
Research Site, Paris Cedex 5, , France
Research Site, Paris, , France
Research Site, Rennes, , France
Research Site, Bangalore, , India
Research Site, Chennai, , India
Research Site, Kolkata, , India
Research Site, New Delhi, , India
Research Site, Avellino, , Italy
Research Site, Firenze, , Italy
Research Site, Milano, , Italy
Research Site, Milano, , Italy
Research Site, Orbassano, , Italy
Research Site, Padova, , Italy
Research Site, Parma, , Italy
Research Site, Perugia, , Italy
Research Site, Peschiera Del Garda, , Italy
Research Site, Fukuoka, , Japan
Research Site, Hiroshima-shi, , Japan
Research Site, Kanazawa-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Niigata-shi, , Japan
Research Site, Osakasayama, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Sunto-gun, , Japan
Research Site, Wakayama-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Goyang-si, , Korea, Republic of
Research Site, Seongnam-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Suwon, , Korea, Republic of
Research Site, Hato Rey, , Puerto Rico
Research Site, Cordoba, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Málaga, , Spain
Research Site, San Sebastian, , Spain
Research Site, Valencia, , Spain
Research Site, Zaragoza, , Spain
Research Site, Hsinchu, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, New Taipei, , Taiwan
Research Site, Taichung City, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan City, , Taiwan
Research Site, Taipei City, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan, , Taiwan
Research Site, Ha Noi, , Vietnam
Research Site, Ha Noi, , Vietnam
Research Site, Ho Chi Minh City, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Contact Details
Name: Lecia V Sequist, MD MPH
Affiliation: Massachusetts General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Myung-Ju Ahn, MD
Affiliation: Samsung Medical Centre Sungkyunkwan University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
