Continuation of TKI With or Without Chemotherapy Beyond Gradual Progression

NCT ID: NCT01998061

Last Updated: 2013-12-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-12-31

Brief Summary

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.

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

TKI alone until rapid progression

Group Type: EXPERIMENTAL

EGFR tyrosine kinase inhibitor

Intervention Type: DRUG

Arm A

Arm B

TKI combined with investigator's choice of chemotherapy regimen and subsequent line of treatment until rapid progression.

Group Type: EXPERIMENTAL

EGFR tyrosine kinase inhibitor with chemotherapy

Intervention Type: DRUG

Arm B

Interventions

EGFR tyrosine kinase inhibitor

Arm A

Intervention Type: DRUG

EGFR tyrosine kinase inhibitor with chemotherapy

Arm B

Intervention Type: DRUG

Other Intervention Names

EGFR TKI; EGFR TKI with chemotherapy

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Qiong Zhao

Chief of Department of Thoracic Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qiong Zhao

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Qiong Zhao, PhD

Role: primary

Other Identifiers

ZhejiangU

Identifier Type: -

Identifier Source: org_study_id