A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.

December 12, 2014 updated by: Hoffmann-La Roche

A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).

This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Campbelltown, Australia, 2560
      • Camperdown, Australia, 2050
      • Liverpool, Australia, 2170
  • China
      • Guangzhou, China, 510060
      • Guangzhou, China, 510080
      • Shanghai, China, 200433
      • Shanghai, China, 200030
  • Hong Kong
      • Hong Kong, Hong Kong
  • Indonesia
      • Jakarta, Indonesia, 10430
      • Jakarta, Indonesia, 10410
      • Jogjakarta, Indonesia, 55284
      • Semarang, Indonesia, 50136
  • Korea, Republic of
      • Kyunggi-do, Korea, Republic of, 411-769
  • Philippines
      • Manila, Philippines, 1000
      • Metro Manila, Philippines, 1502
  • Taiwan
      • Taipei, Taiwan
      • Taipei, Taiwan, 100
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
  • measurable disease;
  • no previous chemotherapy for non-small cell lung cancer.

Exclusion Criteria:

  • unstable systemic disease;
  • any other malignancies in the last 5 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tarceva + gemcitabine/platinum
Drug: erlotinib [Tarceva]
150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily
Drug: gemcitabine
1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles
Drug: cisplatin
75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin
Drug: carboplatin
5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin
Placebo Comparator: Placebo + gemcitabine/platinum
Drug: gemcitabine
1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles
Drug: cisplatin
75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin
Drug: carboplatin
5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin
Drug: placebo
orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Week 8
Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.
Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST
Time Frame: Week 16
Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST.
Week 16
Percentage of Participants With Confirmed CR or PR as Assessed by RECIST
Time Frame: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Duration of Response
Time Frame: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases
Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases
Time to Progression
Time Frame: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Progression-Free Survival (PFS)
Time Frame: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Overall Survival
Time Frame: Date of randomization until date of death or date of last follow-up assessment
Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.
Date of randomization until date of death or date of last follow-up assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MO18633

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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