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

NCT ID: NCT04332367

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

Carboplatin IV

Paclitaxel

Intervention Type DRUG

Paclitaxel IV

Ramucirumab

Intervention Type DRUG

Ramucirumab IV

Interventions

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Carboplatin

Carboplatin IV

Intervention Type DRUG

Paclitaxel

Paclitaxel IV

Intervention Type DRUG

Ramucirumab

Ramucirumab IV

Intervention Type DRUG

Other Intervention Names

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Paraplatin Abraxane, Taxol Cyramza

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melina Marmarelis, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Melissa Volpe, BA

Role: CONTACT

215-220-9703

Melina Marmarelis, MD

Role: CONTACT

267-438-8154

Facility Contacts

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Melissa Volpe

Role: primary

215-220-9703

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB833759

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 05519

Identifier Type: -

Identifier Source: org_study_id

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