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Recruiting NCT04332367

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

Phase II Interventional Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carboplatin, Paclitaxel, Ramucirumab.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Carboplatin
    Carboplatin IV
  • Drug Paclitaxel
    Paclitaxel IV
  • Drug Ramucirumab
    Ramucirumab IV

Primary outcome measures

  • To estimate overall response rate [Time frame: 3 years]
Secondary outcome measures (3)
  • 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]
  • Overall Survival [Time frame: 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 [Time frame: Initiation through 30 days following the last administration of study treatment.]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Abramson Cancer Center of the University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT04332367 · UPCC 05519 · IRB833759

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗