A Study Comparing Pemetrexed Plus Cisplatin Versus Pemetrexed Alone in NSCLC Patients Who Have Progressed on First Line EGFR-TKI

February 9, 2017 updated by: Myung-Ju Ahn, Samsung Medical Center

A Randomized, Open Label, Phase II Study Comparing Pemetrexed Plus Cisplatin Followed by Pemetrexed Until Progression Versus Pemetrexed Alone Until Progression in Non-small Cell Lung Cancer Patients Who Have Progressed on First Line Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)

It has not been established whether platinum-based doublets is better than single agent chemotherapy in EGFR mutant NSCLC patients who failed first-line EGFR TKI.

In this prospective trial, the investigators try to evaluate whether the progression-free survival of pemetrexed/cisplatin (PC) regimen is longer than that of pemetrexed single(P) regimen in NSCLC patients who have progressed after first line treatment of EGFR-TKI.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed nonsquamous NSCLC with activating EGFR mutation (on exon 19 deletion or exon 21 L858R mutation)
  • Stage IIIb, IV or recurrent NSCLC (AJCC 7th criteria)
  • Age ≥ 20 years
  • ECOG performance status of 0 or 1
  • At least one measurable lesion by RECIST 1.1
  • Progression after first line treatment with EGFR TKIs for advanced NSCLC
  • Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
  • At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy
  • Adequate renal function: estimated creatinine clearance ≥ 45 mL/min
  • Organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 3 UNL, in case of known hepatic metastasis, AST/ALT< 5 UNL
  • Written informed consent form
  • No other previous systemic chemotherapy

Exclusion Criteria:

  • Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
  • Patients with post-obstructive pneumonia or uncontrolled serious infection
  • Pregnant or nursing women (Women of reproductive potential have to agree to use an effective contraceptive method)
  • Uncontrolled symptomatic brain metastasis
  • Presence of third space fluid which cannot be controlled by drainage
  • Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pem/Cis
Pem/Cis IV every 3 weeks
Drug: Cisplatin
cisplatin is added to Pem/cis arm
Drug: Pemetrexed
Pem is applied to both arms
Active Comparator: Pem alone
Pem IV alone every 3 weeks
Drug: Pemetrexed
Pem is applied to both arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Myung-Ju Ahn, MD, phD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

February 9, 2017

First Posted (Actual)

February 10, 2017

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-12-035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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