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

Primary Purpose

Non-small Cell Lung Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Carboplatin

Paclitaxel

Ramucirumab

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Abramson Cancer Center of the University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carboplatin, Taxane And Ramucirumab

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression-free survival

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.

Overall Survival

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.

Safety Evaluations: number of Grade ≥ 3 as determined by CTCAE v 5.0

Toxicity will be estimated by the number of Grade ≥ 3 as determined by CTCAE v 5.0.

Full Information

NCT ID

NCT04332367

First Posted

March 11, 2020

Last Updated

August 1, 2023

Sponsor

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04332367

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

April 2025 (Anticipated)

Study Completion Date

April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Carboplatin, Taxane And Ramucirumab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Paraplatin

Intervention Description

Carboplatin IV

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Abraxane, Taxol

Intervention Description

Paclitaxel IV

Intervention Type

Drug

Intervention Name(s)

Ramucirumab

Other Intervention Name(s)

Cyramza

Intervention Description

Ramucirumab IV

Primary Outcome Measure Information:

Title

To estimate overall response rate

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.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Progression-free survival

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.

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

Title

Overall Survival

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.

Time Frame

from the first dose of study drug until death, last observation or contact, an average of 1-2 years

Title

Safety Evaluations: number of Grade ≥ 3 as determined by CTCAE v 5.0

Description

Toxicity will be estimated by the number of Grade ≥ 3 as determined by CTCAE v 5.0.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Melissa Volpe, BA

Phone

215-220-9703

Melissa.volpe@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Melina Marmarelis, MD

Phone

267-438-8154

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melina Marmarelis, MD

Organizational Affiliation

Abramson Cancer Center at Penn Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abramson Cancer Center of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melissa Volpe

Phone

215-220-9703

Melissa.volpe@pennmedicine.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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