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Predicting response to therapy and disease progression in stage IV NSCLC patients treated with pembrolizumab monotherapy, chemotherapy-pembrolizumab combination therapy or chemotherapy alone in the first-line setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab monotherapy |
| ||
| Chemotherapy and pembrolizumab combination therapy |
| ||
| Chemotherapy doublet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Predictive models (data collection) | Other | Machine learning predictive models |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response at first evaluation | Predict treatment response at first evaluation using baseline data | 6-12 weeks after treatment start |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | Predict Progression-Free Survival (PFS) using data at baseline and first evaluation | Through study completion, expected 6-14 months contingent on cohort |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients diagnosed with stage IV NSCLC (de novo or earlier stage progression to stage IV), without oncogene-activating mutations eligible for targeted therapy, that are treated in the first-line setting with either pembrolizumab monotherapy, chemotherapy and pembrolizumab combination therapy, or chemotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Menu, MD-PhD, MBA | SOPHiA GENETICS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holden Comprehensive Cancer Center at University of Iowa Health Care | Iowa City | Iowa | 52242 | United States | ||
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Predict Overall Survival (OS) using data at baseline and first evaluation
| Through study completion, expected 8-20 months contingent on cohort |
| Duration of Response | Predict Duration of Response (DoR) using data at baseline and first evaluation | Through study completion, expected 6-14 months contingent on cohort |
| Time-To-Progression | Predict Time-To-Progression (TTP) using data at baseline and first evaluation | Through study completion, expected 6-14 months contingent on cohort |
| UMASS Memorial Health |
| Worcester |
| Massachusetts |
| 01655 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14203 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Carbone Comprehensive Cancer Center at University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| DASA - Hospital Brasilia | Brasília | 71681-603 | Brazil |
| DASA - Hospital de Niteroi | Niterói | 24020-096 | Brazil |
| DASA - Hospital São Lucas | Rio de Janeiro | 22061-080 | Brazil |
| DASA - Hospital Nove De Julho | São Paulo | 01409-902 | Brazil |
| AC Camargo | São Paulo | Brazil |
| Sunnybrook Health Sciences Centre Toronto | Toronto | Canada |
| Avicenne Hospital | Bobigny | 93000 | France |
| CHU Bordeaux | Bordeaux | France |
| Ambroise Paré Hospital | Boulogne-Billancourt | 92100 | France |
| Hospices Civils de Lyon | Lyon | 69002 | France |
| CHU de Nantes | Nantes | 44093 | France |
| La Pitié Salpêtrière | Paris | 75013 | France |
| Tenon Hospital | Paris | 75020 | France |
| Foch Hospital | Suresnes | 92150 | France |
| Centre Hospitalier de Toulon | Toulon | 83100 | France |
| University Hospital Leipzig | Leipzig | 04103 | Germany |
| Shaare Zadek Medical Center | Jerusalem | Israel |
| Sourasky Medical Center | Tel Aviv | Israel |
| University Hospital Of Parma | Parma | 43100 | Italy |
| Policlinico Gemelli | Roma | Italy |
| Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) | Udine | 33100 | Italy |
| Fundacion jimenez diaz | Madrid | 28040 | Spain |
| Puerta De Hierro Hospital | Madrid | 28222 | Spain |
| Instituto Valenciano De Oncologia | Valencia | 46009 | Spain |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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