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Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04332367
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Carboplatin Drug: Paclitaxel Drug: Ramucirumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Carboplatin
Carboplatin IV
Other Name: Paraplatin

Drug: Paclitaxel
Paclitaxel IV
Other Name: Abraxane, Taxol

Drug: Ramucirumab
Ramucirumab IV
Other Name: Cyramza




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older
  • Prior exposure to 4-6 cycles of Pem/Carbo/Pembro and PD after at least 18 weeks of maintenance Pemetrexed, Pembrolizumab or the combination of the two.
  • PS 0-1

Exclusion Criteria:

  • Presence of a driver mutation that is susceptible to targeted therapy
  • Other active invasive malignancy requiring ongoing therapy
  • Grade 2 or higher sensory neuropathy
  • Evidence of untreated brain metastases
  • History of bleeding diatheses or recent, antecedent hemoptysis (> 1/2 teaspoon in prior 2 months)

Information from the National Library of Medicine

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


Contacts
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Contact: Melissa Volpe, BA 215-220-9703 Melissa.volpe@pennmedicine.upenn.edu
Contact: Melina Marmarelis, MD 267-438-8154

Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Melissa Volpe    215-220-9703    Melissa.volpe@pennmedicine.upenn.edu   
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Melina Marmarelis, MD Abramson Cancer Center of the University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Abramson Cancer Center of the University of Pennsylvania:
Informed Consent Form  [PDF] December 12, 2019

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04332367    
Other Study ID Numbers: UPCC 05519
IRB833759 ( Other Identifier: University of Pennsylvania )
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Carboplatin
Ramucirumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action