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

Non-small Cell Lung Cancer Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04332367
• Other study ID #: UPCC 05519
• Secondary ID: IRB833759
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2020
• Est. completion date: April 2025

Study information

• Verified date: August 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Melissa Volpe, BA
• Phone: 215-220-9703
• Email: Melissa.volpe[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 59
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From first dose of study drug until progressive disease, death or last assessment contact, whichever comes first, an average of 1-2 years
Secondary	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.	from the first dose of study drug until death, last observation or contact, an average of 1-2 years
Secondary	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.	Initiation through 30 days following the last administration of study treatment.