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| ID | Type | Description | Link |
|---|---|---|---|
| IRB833759 | Other Identifier | University of Pennsylvania |
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The purpose of this study is to determine if the combination of the three anti-cancer drugs carboplatin, paclitaxel, and ramucirumab is helpful in shrinking tumors or delaying tumor growth in participants with non-small cell lung cancer. This study will also assess whether it is safe to combine these drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboplatin, Taxane And Ramucirumab | Experimental | Carboplatin AUC 5 IV every 3 wks, Paclitaxel 80 mg/m2 IV days 1 and 8 every 3 weeks, and Ramucirumab 10 mg/kg IV every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Carboplatin IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| To estimate overall response rate | Overall response rate (ORR) as determined by RECIST criteria. Response will be defined by a complete response (CR) or partial response (PRO), confirmed or unconfirmed. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival (PFS) defined as the duration from the first study dose of study drug until progressive disease, death or last assessment contact whichever comes first. | From first dose of study drug until progressive disease, death or last assessment contact, whichever comes first, an average of 1-2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Volpe, BA | Contact | 215-220-9703 | Melissa.volpe@pennmedicine.upenn.edu | |
| Melina Marmarelis, MD | Contact | 267-438-8154 |
| Name | Affiliation | Role |
|---|---|---|
| Melina Marmarelis, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 12, 2019 | Mar 10, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D000096662 | Ramucirumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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| Paclitaxel | Drug | Paclitaxel IV |
|
|
| Ramucirumab | Drug | Ramucirumab IV |
|
|
| Overall Survival | Overall Survival (OS) is defined as the time from the first dose of study drug until death due to any cause or last observation or contact. | from the first dose of study drug until death, last observation or contact, an average of 1-2 years |
| Safety Evaluations: number of Grade ≥ 3 as determined by CTCAE v 5.0 | Toxicity will be estimated by the number of Grade ≥ 3 as determined by CTCAE v 5.0. | Initiation through 30 days following the last administration of study treatment. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |