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

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04332367
Collaborator
(none)
59
Enrollment
1
Location
1
Arm
59.4
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 19, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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 Names:
  • Paraplatin

    • Drug: Paclitaxel
    Paclitaxel IV
    Other Names:
  • Abraxane, Taxol

    • Drug: Ramucirumab
    Ramucirumab IV
    Other Names:
  • Cyramza

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To estimate overall response rate [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Abramson Cancer Center of the University of Pennsylvania

    Investigators

    • Principal Investigator: Melina Marmarelis, MD, Abramson Cancer Center of the University of Pennsylvania

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Abramson Cancer Center of the University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT04332367
    Other Study ID Numbers:
    • UPCC 05519
    • IRB833759
    First Posted:
    Apr 2, 2020
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Paclitaxel
    Carboplatin
    Ramucirumab

    Study Results

    No Results Posted as of Mar 15, 2022