Continuation of TKI With or Without Chemotherapy Beyond Gradual Progression

Phase II Study of Continuation of Tyrosine Kinase Inhibitor (TKI) With or Without Chemotherapy Beyond Gradual Progression in Advanced Non-small Cell Lung Cancer (NSCLC)

There have been reports suggesting that continuous administration of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) is advantageous for patients in which gradual disease progression was observed after the establishment of clinical benefit from EGFR-TKIs. However, whether EGFR TKI with or without chemotherapy provides more survival benefit has not been formally evaluated.

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: EGFR tyrosine kinase inhibitor; Drug: EGFR tyrosine kinase inhibitor with chemotherapy

Detailed Description

We design this clinical trial to compare the efficacy of continuation of EGFR TKI with or without chemotherapy in patients beyond gradual progression.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • Qiong Zhao
      • Contact: Qiong Zhao, PhD; Phone Number: 0571-87236802; Email: doczq.2008@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

Patient who was confirmed stage IV NSCLC by pathologic histology or cytology. Males or females aged ≥18 years, < 75 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks.

Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.

Definition of gradual progression:

1. Slow PD (6 months of partial response/stable disease),
2. Asymptomatic minimal PD,
3. New brain metastasis controlled locally. Patients with asymptomatic, treated brain metastases are eligible for trial participation.

Adequate bone marrow, renal, and liver function are required. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.

Exclusion criteria： Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).

Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.

Female subjects should not be pregnant or breast-feeding. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.

Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function :Total bilirubin £ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT )and Aspartate Aminotransferase (AST )< 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.

Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; TKI alone until rapid progression	Drug: EGFR tyrosine kinase inhibitor; Arm A; Other Names: EGFR TKI
Experimental: Arm B; TKI combined with investigator's choice of chemotherapy regimen and subsequent line of treatment until rapid progression.	Drug: EGFR tyrosine kinase inhibitor with chemotherapy; Arm B; Other Names: EGFR TKI with chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	up to 18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective response rate cacy	up to 18 months

Other Outcome Measures

Outcome Measure	Time Frame
Quality of life	up to 24 months

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: November 24, 2013
• First Submitted That Met QC Criteria: November 24, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): December 20, 2013
• Last Update Submitted That Met QC Criteria: December 19, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• 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
• Other Study ID Numbers: ZhejiangU