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

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: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Cisplatin; Drug: Pemetrexed

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Myung-Ju Ahn, Ph.D.; Phone Number: 822-3410-1795; Email: silkahn@skku.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	2 years

Collaborators and Investigators

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

Study record dates

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: Pemetrexed; EGFR Activating Mutation; Failed in First Line EGFR-TKI
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Pemetrexed
• Other Study ID Numbers: 2012-12-035