A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183858
• Other study ID #: MO22162
• Secondary ID: 2010-018476-24
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2010
• Last updated: July 23, 2015
• Start date: October 2010
• Est. completion date: February 2014

Study information

• Verified date: July 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española del Medicamento y Productos sanitarios (AEMPS)
• Study type: Interventional

Clinical Trial Summary

This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: February 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients aged =18 years

• inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)

• Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria

• Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Life expectancy =12 weeks

• Current cigarette smoker (having smoked >100 cigarettes in entire lifetime and currently smoking on average =1 cigarette per day), not intending to stop during the study

Exclusion Criteria:

• Prior antibody or small molecule therapy against Epidermal growth factor receptor (EGFR)

• Radiotherapy within 28 days prior to enrollment

• Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Erlotinib [Tarceva]
Single daily oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

China,  Denmark,  Egypt,  France,  Germany,  Netherlands,  Spain,  Switzerland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.	Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)	No
Primary	Progression-Free Survival (PFS) at the End of Study	PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.	Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)	No
Secondary	Overall Survival (OS)	OS defined as the time from randomization to the date of death due to any cause.	Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)	No
Secondary	Overall Response Rate (ORR)	Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented.	Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)	No
Secondary	Disease Control Rate (DCR)	Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented.	Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)	No
Secondary	Time to Progression (TTP)	Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.	Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)	No
Secondary	Number of Participants With Adverse Events (AEs) at the End of the Study	An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.; A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.; Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death.	Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)	No
Secondary	Overall Survival (OS) at the End of Study	OS defined as the time from randomization to the date of death due to any cause.	Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)	No