Comparison of Cost-effectiveness of Continuation Maintenance Therapy With Six Cycles of Pemetrexed Versus Pemetrexed Until Disease Progression for Metastatic Non-squamous Non-small-cell Lung Cancer

NCT02397239 | Unknown DMC

• 3 other identifiers: A-BR-103-062MOHW103-TD-B-111-06MOHW103-TDU-B-211-113002
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Protocol title: Comparison of cost-effectiveness of continuation maintenance therapy with six cycles of pemetrexed versus pemetrexed until disease progression for metastatic non-squamous non-small-cell lung cancer (NSCLC) Study design: An open-labelled, randomized, phase 2 trial Indication: Patients with stage IV non-squamous NSCLC, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and have received first-line or second-line chemotherapy with pemetrexed plus platinum for 4 cycles Treatment: Maintenance pemetrexed 500 mg/m2 every 3 weeks for six cycles versus until disease progression Objectives: Primary endpoint: 1\. Progression-free survival in the intention-to-treat population Secondary endpoints:

1. 1.Cost-effectiveness
2. 2.Overall survival
3. 3.Quality-of-life (QoL)
4. 4.Quality-adjusted progression-free survival (QA-PFS)
5. 5.Quality-adjusted life expectancy (QALE)
6. 6.Tumor response rate
7. 7.Adverse events

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  1 year

Secondary Outcomes (7)

• Cost-effectiveness: Cost/QA-PFS

  2 years

• Overall survival

  1 year

• Quality-of-life (QoL) Questionnaire

  1 year

• Quality-adjusted progression-free survival (QA-PFS)

  1 year

• Quality-adjusted life expectancy (QALE)

  1 year

Study Arms (2)

Six cycles

Maintenance pemetrexed 500 mg/m2 every 3 weeks for six cycles

Until disease progression

Maintenance pemetrexed 500 mg/m2 every 3 weeks until disease progression

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with metastatic non-squamous mon-small-cell lung cancer

You may qualify if:

• Males and females ≥ 20 years of age
• ECOG performance status of 0-1
• Histologically or cytologically verified non-squamous NSCLC
• Stage IV disease, as defined by American Joint Committee on Cancer 7th edition staging, prior to first-line or second-line chemotherapy with pemetrexed plus platinum
• At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Completion of 4 cycles of first-line or second-line chemotherapy with pemetrexed plus platinum and documented radiographic evidence of a complete or partial tumor response or stable disease by RECIST 1.1
• Adequate organ function, including followings:
• Bone marrow:
• Absolute neutrophil count ≥ 1.5 x 103 /μL White blood cell ≥ 3.0 x 103 /μL Platelet count ≥ 75 x 103 /μL Hemoglobin ≥ 8.0 g/dL
• Hepatic:
• Total bilirubin ≤ 1.5 x upper normal limit (UNL) Aspartate aminotransferase (AST) ≤ 3.0 x UNL (≤ 5.0 x UNL if liver metastasis) Alanine aminotransferase (ALT) ≤ 3.0 x UNL (≤ 5.0 x UNL if liver metastasis)
• Renal:
• Estimated glomerular filtration rate ≥ 30 mL/min
• Estimated life expectancy of at least 6 months
• Ability to comply with study and follow-up procedures

You may not qualify if:

• Squamous cell and/or mixed small-cell, non-small-cell histology
• Prior participation in any investigational drug study within 4 weeks
• Prior malignancy other than NSCLC, except those remain disease-free for ≥ 3 years after curative treatment, non-melanoma skin cancer or in situ cervical cancer
• Serious concomitant systemic disorders, such as acute or recent myocardial infarction (\< 6 months before enrollment), congestive heart failure with New York Heart Association functional class II\~IV, frequent exacerbations of chronic obstructive pulmonary disease (≥ 2 hospitalizations per year), or recent cerebrovascular disease (\< 6 months before enrollment)
• Active uncontrolled infections or HIV infection
• Current or planned pregnancy, or breast feeding in women
• Symptomatic central nervous system metastasis unless the patient has completed successful local therapy and has been off corticosteroids for ≥ 4 weeks
• Concurrent administration of any other antitumor therapy including chemotherapy, target therapy, immunotherapy, and hormone therapy
• Psychiatric disorders that would compromise the patient's compliance or decision

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood hemoglobin, white blood cell, absolute neutrophil count, platelet count, total bilirubin, aspartate aminotransferase, alanine aminotransferase, creatinine

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Szu-Chun Yang, M.D.

CONTACT

+886-6-2353535; szuchunyang@yahoo.com.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 24, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2018
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

TW (1)