Continuation of TKI With or Without Chemotherapy Beyond Gradual Progression

NCT01998061 | Unknown Phase 2

• 1 other identifier: ZhejiangU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  up to 18 months

Secondary Outcomes (1)

• Objective response rate cacy

  up to 18 months

Other Outcomes (1)

• Quality of life

  up to 24 months

Study Arms (2)

Arm A

EXPERIMENTAL

TKI alone until rapid progression

Drug: EGFR tyrosine kinase inhibitor

Arm B

EXPERIMENTAL

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

Drug: EGFR tyrosine kinase inhibitor with chemotherapy

Interventions

EGFR tyrosine kinase inhibitor DRUG

Arm A

Also known as: EGFR TKI

Arm A

EGFR tyrosine kinase inhibitor with chemotherapy DRUG

Arm B

Also known as: EGFR TKI with chemotherapy

Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Slow PD (6 months of partial response/stable disease),
• Asymptomatic minimal PD,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Qiong Zhao

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

EGFR tyrosine kinase inhibitor 324674; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Thoracic Oncology

Study Record Dates

• First Submitted: November 24, 2013
• First Posted: November 28, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

CN (1)