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

NCT03050437

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 2012-12-035
  • NCT ID: NCT03050437

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
CisplatinPem/Cis
PemetrexedPem/Cis

Purpose

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 Arms

NameTypeDescriptionInterventions
Pem/CisExperimentalPem/Cis IV every 3 weeks
  • Cisplatin
  • Pemetrexed
Pem aloneActive ComparatorPem IV alone every 3 weeks
  • Pemetrexed

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:progression-free survival
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Samsung Medical Center

Trial Keywords

  • Failed in First Line EGFR-TKI
  • EGFR Activating Mutation
  • Pemetrexed

Last Updated

February 9, 2017