Clinical Trials /

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

NCT04332367

Description:

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.

Related Conditions:
  • Non-Squamous Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04332367

Trial Eligibility

Document

Title

  • Brief Title: Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
  • 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

Clinical Trial IDs

  • ORG STUDY ID: UPCC 05519
  • SECONDARY ID: IRB833759
  • NCT ID: NCT04332367

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
CarboplatinParaplatinCarboplatin, Taxane And Ramucirumab
PaclitaxelAbraxane, TaxolCarboplatin, Taxane And Ramucirumab
RamucirumabCyramzaCarboplatin, Taxane And Ramucirumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Carboplatin, Taxane And RamucirumabExperimentalCarboplatin 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
  • Carboplatin
  • Paclitaxel
  • Ramucirumab

Eligibility 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)
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:To estimate overall response rate
Time Frame:3 years
Safety Issue:
Description: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

Measure: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
Safety Issue:
Description: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.
Measure:Overall Survival
Time Frame:from the first dose of study drug until death, last observation or contact, an average of 1-2 years
Safety Issue:
Description: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.
Measure: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.
Safety Issue:
Description:Toxicity will be estimated by the number of Grade ≥ 3 as determined by CTCAE v 5.0.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Abramson Cancer Center of the University of Pennsylvania

Last Updated

January 12, 2021