NCT03050437

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

3.9 years

First QC Date

September 22, 2015

Last Update Submit

February 9, 2017

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Failed in First Line EGFR-TKIEGFR Activating MutationPemetrexed

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    2 years

Study Arms (2)

Pem/Cis

EXPERIMENTAL

Pem/Cis IV every 3 weeks

Drug: CisplatinDrug: Pemetrexed

Pem alone

ACTIVE COMPARATOR

Pem IV alone every 3 weeks

Drug: Pemetrexed

Interventions

CisplatinDRUG

cisplatin is added to Pem/cis arm

Pem/Cis
PemetrexedDRUG

Pem is applied to both arms

Pem alonePem/Cis

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CisplatinPemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Myung-Ju Ahn, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ju Yeon Park, RN

CONTACT

82-2-3410-3459jy1223.park@samsung.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 22, 2015

First Posted

February 10, 2017

Study Start

March 1, 2013

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

KR(1)