NCT04332367

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Aug 2020

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

5.7 years

First QC Date

March 11, 2020

Last Update Submit

January 5, 2026

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • To estimate overall response rate

    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.

    3 years

Secondary Outcomes (3)

  • 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

  • Overall Survival

    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

    Initiation through 30 days following the last administration of study treatment.

Study Arms (1)

Carboplatin, Taxane And Ramucirumab

EXPERIMENTAL

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: CarboplatinDrug: PaclitaxelDrug: Ramucirumab

Interventions

CarboplatinDRUG

Carboplatin IV

Also known as: Paraplatin
Carboplatin, Taxane And Ramucirumab
PaclitaxelDRUG

Paclitaxel IV

Also known as: Abraxane, Taxol
Carboplatin, Taxane And Ramucirumab
RamucirumabDRUG

Ramucirumab IV

Also known as: Cyramza
Carboplatin, Taxane And Ramucirumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CarboplatinPaclitaxelAlbumin-Bound PaclitaxelRamucirumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulins

Study Officials

  • Melina Marmarelis, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Volpe, BA

CONTACT

215-220-9703Melissa.volpe@pennmedicine.upenn.edu

Melina Marmarelis, MD

CONTACT

267-438-8154

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

April 2, 2020

Study Start

August 1, 2020

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)