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

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ClinicalTrials.gov Identifier: NCT03050437
Recruitment Status : Unknown
Verified February 2017 by Myung-Ju Ahn, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Myung-Ju Ahn, Samsung Medical Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Cisplatin Drug: Pemetrexed Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : March 2013
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050437


Contacts
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Contact: Ju Yeon Park, RN 82-2-3410-3459 jy1223.park@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Myung-Ju Ahn, Ph.D.    822-3410-1795    silkahn@skku.edu   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Myung-Ju Ahn, MD, PhD Samsung Medical Center
More Information
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Responsible Party: Myung-Ju Ahn, MD, PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03050437    
Other Study ID Numbers: 2012-12-035
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Keywords provided by Myung-Ju Ahn, Samsung Medical Center:
Failed in First Line EGFR-TKI
EGFR Activating Mutation
Pemetrexed
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors