Non-Small Cell Lung CancerPhase 1/2NCT00453362

A Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib

A Phase 1/2 study testing 2-deoxy-2-[18F]fluoro-D-glucose (FDG), 3'-deoxy-3'-[18F]fluorothymidine (FLT) and erlotinib HCl in people with Non-Small Cell Lung Cancer, run by Genentech, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single-arm, open-label, multicenter, international pilot study to evaluate changes that occur in 2-deoxy-2-[18F]fluoro-D-glucose (FDG)- and 3'-deoxy-3'-[18F]fluorothymidine(FLT)-PET (Positron Emission Tomography) imaging as a result of treatment with erlotinib in patients with recurrent or refractory… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: 2-deoxy-2-[18F]fluoro-D-glucose (FDG), 3'-deoxy-3'-[18F]fluorothymidine (FLT) and erlotinib HCl
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: No sites listed yet
Study dates: Dec 2006to 23 Apr 2010
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed Informed Consent Form(s)
Histologically confirmed NSCLC
Recurrent or progressive disease after receiving at least one chemotherapy regimen for advanced or metastatic NSCLC
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Age ≥ 18 years
Recovery from reversible acute effects of prior anti-cancer therapy (chemotherapy, radiotherapy, or investigational treatment) to NCI Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 (excluding alopecia)

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Ability to comply with the study and follow-up procedures, including all specified imaging studies
Ability to take oral medication
Availability of archival diagnostic paraffin-embedded tumor tissue and willingness to provide sufficient tissue for testing for EGFR levels in tumor by both immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH)
Life expectancy ≥ 3 months
Measurable disease on computed tomography (CT)
At least one detectable lesion on FDG-PET scan and/or FLT-PET scan that is measurable on CT
Use of an acceptable means of contraception (men and women of childbearing potential) or documentation of infertility

Who cannot join

Prior treatment with an investigational or marketed agent for the purpose of inhibiting epidermal growth factor receptor (EGFR) (including, but not limited to, erlotinib and gefitinib)
Chemotherapy, radiotherapy, or investigational treatment within 14 days or within 5 half-lives of the active molecules in the chemotherapy or investigational treatment, whichever is longer, prior to study entry or from which patients have not yet recovered
Inability to take oral medications, disease affecting gastrointestinal absorption, or prior surgical procedure affecting gastrointestinal absorption
Uncontrolled diabetes
Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within 1 month prior to study entry, hepatic, renal, or metabolic disease)
Pregnancy or lactation

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History of another malignancy in the past 2 years, unless the malignancy has been adequately treated, is currently not detectable, and is associated with a 5-year survival > 90%
Claustrophobia
Any other disease, condition, physical examination finding, or clinical laboratory finding which, in the opinion of the investigator, makes the patient inappropriate for the study

About this study

Official title: Pilot Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib

Conditions: Non-Small Cell Lung Cancer
Being tested: 2-deoxy-2-[18F]fluoro-D-glucose (FDG), 3'-deoxy-3'-[18F]fluorothymidine (FLT), erlotinib HCl
Keywords: NSCLC, Tarceva, Positron emission technology, PET, Computerized tomography, CT
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

2-deoxy-2-[18F]fluoro-D-glucose (FDG)Other
FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie).
3'-deoxy-3'-[18F]fluorothymidine (FLT)Other
FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection.
erlotinib HClDrug
Also called Tarceva
Tablets taken orally 150 mg/day.

Study groups in NCT00453362
Study group	Role	What they receive
Erlotinib	Experimental	Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity. After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET and FLT-PET scans. Receives: Other: 2-deoxy-2-[18F]fluoro-D-glucose (FDG); Other: 3'-deoxy-3'-[18F]fluorothymidine (FLT); Drug: erlotinib HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS) of Groups by FDG Response at Day 56
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.
PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.
Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax <-25%.
Measured: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.
PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of <-25% and FDG-PET disease progression; defined as a mSUVmax >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Measured: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
Progression Free Survival of Groups by FLT Response at Day 56
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.
PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.
FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%.
Measured: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.
PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib.
FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Measured: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
Overall Survival of Groups by FDG Response at Day 56
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.
Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25%.
Measured: From first erlotinib treatment to death, assessed up to 2 years
Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.
OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.
FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Measured: From first erlotinib treatment to death, assessed up to 2 years
Overall Survival of Groups by FLT Response at Day 56
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.
OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.
FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%.
Measured: From first erlotinib treatment to death, assessed up to 2 years
Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.
OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.
FLT-PET response was defined as a mSUVmax from FLT-PET scans of <-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Measured: From first erlotinib treatment to death, assessed up to 2 years

Secondary outcomes (5)

Percentage of Patients With FDG-PET Responses
In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment.
FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25%.
CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Measured: Day 14 and Day 56
Percentage of Patients With FLT-PET Responses
In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment.
FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Measured: Day 14 and Day 56
FDG Response in Subgroups by CT Response at Day 56
In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans <-25%.
CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.
CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions.
Measured: Day 56
FLT Response in Subgroups by CT Response at Day 56
In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans <-25%.
CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.
CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions.
Measured: Day 56
Number of Participants With Adverse Events Due to FLT-PET Imaging
The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET.
Measured: From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 200623 Apr 2010

First posted28 Mar 2007 (estimated)
Study startDec 2006
Primary completionApr 2010
Study completion23 Apr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00453362
Sponsor's protocol ID: OSI3926g
Other IDs: ML20773
Status last verified: Oct 2011
First submitted: 26 Mar 2007
Last updated: 31 Mar 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Non Small Cell Lung Cancer
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Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
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Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib
ClinicalTrials.gov ID: NCT00453362
Acronym / sponsor ID: OSI3926g
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC, Tarceva, Positron emission technology, PET, Computerized tomography, CT
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Collaborators: Roche Pharma AG
Study start: Dec 2006
Primary completion: Apr 2010 (actual)
Study completion: 23 Apr 2010 (actual)
First posted: 28 Mar 2007 (estimated)
Results: Posted 3 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Erlotinib	Experimental	Other: 2-deoxy-2-[18F]fluoro-D-glucose (FDG), Other: 3'-deoxy-3'-[18F]fluorothymidine (FLT), Drug: erlotinib HClErlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity. After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET and FLT-PET scans.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Signed Informed Consent Form(s)
Histologically confirmed NSCLC
Recurrent or progressive disease after receiving at least one chemotherapy regimen for advanced or metastatic NSCLC
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Age ≥ 18 years

Key exclusion criteria (9 listed)

Prior treatment with an investigational or marketed agent for the purpose of inhibiting epidermal growth factor receptor (EGFR) (including, but not limited to, erlotinib and gefitinib)
Chemotherapy, radiotherapy, or investigational treatment within 14 days or within 5 half-lives of the active molecules in the chemotherapy or investigational treatment, whichever is longer, prior to study entry or from which patients have not yet recovered
Inability to take oral medications, disease affecting gastrointestinal absorption, or prior surgical procedure affecting gastrointestinal absorption
Uncontrolled diabetes
Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within 1 month prior to study entry, hepatic, renal, or metabolic disease)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
2-deoxy-2-[18F]fluoro-D-glucose (FDG)FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie).	Other	Erlotinib
3'-deoxy-3'-[18F]fluorothymidine (FLT)FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection.	Other	Erlotinib
erlotinib HClAlso: TarcevaTablets taken orally 150 mg/day.	Drug	Erlotinib

Primary outcome

Progression Free Survival (PFS) of Groups by FDG Response at Day 56
Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax <-25%.
PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56
Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of <-25% and FDG-PET disease progression; defined as a mSUVmax >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Progression Free Survival of Groups by FLT Response at Day 56
Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%.
Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Overall Survival of Groups by FDG Response at Day 56
Time frame: From first erlotinib treatment to death, assessed up to 2 years
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25%.
Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56
Time frame: From first erlotinib treatment to death, assessed up to 2 years
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans <-25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Overall Survival of Groups by FLT Response at Day 56
Time frame: From first erlotinib treatment to death, assessed up to 2 years
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans <-25%.
Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
Time frame: From first erlotinib treatment to death, assessed up to 2 years
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans of <-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.

5 secondary outcomes

Percentage of Patients With FDG-PET Responses
Time frame: Day 14 and Day 56
Percentage of Patients With FLT-PET Responses
Time frame: Day 14 and Day 56
FDG Response in Subgroups by CT Response at Day 56
Time frame: Day 56
FLT Response in Subgroups by CT Response at Day 56
Time frame: Day 56
Number of Participants With Adverse Events Due to FLT-PET Imaging
Time frame: From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded.

Results and safety

Results posted to the registry on 3 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erlotinib	88	1

Primary outcome: Progression Free Survival (PFS) of Groups by FDG Response at Day 56

Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years. Median (Full Range). Unit: weeks

Measure	Erlotinib_FDG Responders n = 6	Erlotinib_ FDG Non-Responders n = 45
Value	28.1 (16.14 to 40.14)	12.1 (7.86 to 51.14)

Erlotinib_FDG Responders vs Erlotinib_ FDG Non-Responders: Hazard Ratio (HR): 0.31 (95% CI 0.11 to 0.87), p = 0.017, Log Rank

Population analysed: FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.

Primary outcome: PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56

Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years. Median (Full Range). Unit: weeks

Measure	Erlotinib_FDG Responders With CT SD at Day 56 n = 3	Erlotinib_FDG Progressive Disease With CT SD at Day 56 n = 10
Value	32.1 (18 to 32.14)	14.9 (8.14 to 32.14)

Erlotinib_FDG Responders With CT SD at Day 56 vs Erlotinib_FDG Progressive Disease With CT SD at Day 56: Hazard Ratio (HR): 0.3 (95% CI 0.06 to 1.42), p = 0.076, Log Rank

Population analysed: FDG-Evaluable patients were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment. CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start.

Primary outcome: Progression Free Survival of Groups by FLT Response at Day 56

Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years. Median (Full Range). Unit: weeks

Measure	Erlotinib_FLT Responders n = 4	Erlotinib_ FLT Non-Responders n = 46
Value	39.9 (18 to 40.14)	13.1 (7.86 to 51.14)

Erlotinib_FLT Responders vs Erlotinib_ FLT Non-Responders: Hazard Ratio (HR): 0.17 (95% CI 0.04 to 0.73), p = 0.008, Log Rank

Population analysed: FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.

Primary outcome: Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56

Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years. Median (Full Range). Unit: weeks

Measure	Erlotinib_FLT Responders With CT SD at Day 56 n = 2	Erlotinib_FLT Progressive Disease With CT SD at Day 56 n = 4
Value	NA (18 to 24)	12.9 (8.29 to 17.29)

Erlotinib_FLT Responders With CT SD at Day 56 vs Erlotinib_FLT Progressive Disease With CT SD at Day 56: p = 0.049, Log Rank

Population analysed: FLT-Evaluable patients were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment. CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening to Day 112 assessment visit or study discontinuation or termination, whichever is earlier. On visits after Day 112, only Serious Adverse Events were recorded. (Up to 1 year). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erlotinib	37 of 85 (43.5%)	46 of 85 (54.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Non-Small Cell Lung Cancer

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bernard Fine, M.D. study director

Genentech, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 2-deoxy-2-[18F]fluoro-D-glucose (FDG), 3'-deoxy-3'-[18F]fluorothymidine (FLT) and erlotinib HCl in people with Non-Small Cell Lung Cancer, run by Genentech, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) of Groups by FDG Response at Day 56 (time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00453362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.