Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
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|ClinicalTrials.gov Identifier: NCT04332367|
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : January 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Carboplatin Drug: Paclitaxel Drug: Ramucirumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Single-Arm Study Of Carboplatin, Weekly Taxane, And Ramucirumab In Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) After Progressive Disease On Maintenance Pemetrexed And/Or Pembrolizumab|
|Actual Study Start Date :||December 19, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2024|
Experimental: Carboplatin, Taxane And Ramucirumab
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
Other Name: Paraplatin
Other Name: Abraxane, Taxol
Other Name: Cyramza
- To estimate overall response rate [ Time Frame: 3 years ]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.
- Progression-free survival [ Time Frame: From first dose of study drug until progressive disease, death or last assessment contact, whichever comes first, an average of 1-2 years ]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.
- Overall Survival [ Time Frame: from the first dose of study drug until death, last observation or contact, an average of 1-2 years ]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.
- Safety Evaluations: number of Grade ≥ 3 as determined by CTCAE v 5.0 [ Time Frame: Initiation through 30 days following the last administration of study treatment. ]Toxicity will be estimated by the number of Grade ≥ 3 as determined by CTCAE v 5.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04332367
|Contact: Melissa Volpe, BA||215-220-9703||Melissa.email@example.com|
|Contact: Melina Marmarelis, MD||267-438-8154|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Melissa Volpe 215-220-9703 Melissa.firstname.lastname@example.org|
|Principal Investigator:||Melina Marmarelis, MD||Abramson Cancer Center of the University of Pennsylvania|