Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

GDC-0941

erlotinib HCl

Clinical Trials

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.

A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors

A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors

Genentech, Inc.

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle

oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle

bevacizumab

intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

placebo

This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study. Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.

A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer

A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva (Erlotinib) Compared With Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapy

Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.

PFS was defined as the time from randomization to documented disease progression, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), or death on study treatment, whichever occurred first.

Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions \>= 4 weeks apart.

Duration of objective response was defined as the period from the date of the initial partial or complete response until the date of disease progression or death on study treatment from any cause. For patients who had not died, data was censored at the date of last contact.

Erlotinib HCl + Bevacizumab

Erlotinib HCl + Placebo

Total

Age, Continuous

Age, Customized

Sex: Female, Male

Medical Communications Specialist

Overall Survival (OS) Among All Randomized Patients

Progression-free Survival (PFS)

Only patients with measurable disease at baseline were included in the analysis of the objective response. Patients without a post-baseline tumor assessment were considered non-responder.

Percentage of Participants With Objective Response

Duration of Objective Response

Overall Study

Symptoms and General Pathology

Recurrence

Donald Strickland, M.D.

This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.

A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)

A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer

PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008.

Treatment-emergent adverse events were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.. Number of participants who had Grade \>=3TEAEs of pulmonary hemorrhage, gastrointestinal (GI) perforation, arterial thromboembolic (ATE) events, proteinuria, congestive heart failure (CHF), and hypertension were presented. Data presented up to data cutoff 18 July 2008.

Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. Pulmonary hemorrhage, GI perforation, ATE events, proteinuria, CHF, and hypertension were prospectively identified TEAEs of grade \>=3. Data presented until cut-off date 28 January 2009.

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. Data presented up to data cutoff 19 June 2009.

Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008).

Participants in post-chemotherapy phase were discontinued from the study for the reasons other than disease progression. Data presented Up to data cutoff 18 July 2008.

Overall survival was defined as the length of time from randomization to death.

Safety-evaluable randomized participants who had received at least one complete or partial dose of bevacizumab or erlotinib/placebo.

Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.

Bevacizumab + Placebo

Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.

Bevacizumab + Erlotinib

Participants received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily

Participants received Bevacizumab 15 mg/kg IV on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily

Roche Trial Information Hotline

Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase.

Pulmonary hemorrhage

GI perforation

ATE events

Proteinuria

Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration-time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m\^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.

Carboplatin + Paclitaxel

Participants received IV dose of Carboplatin at a dose based on the AUC of 5 mg/mL × min on Day 1 of each 21-day cycle and Gemcitabine 1200 mg/m\^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.

Carboplatin + Gemcitabine

Participants received IV dose of Carboplatin at a dose based on the AUC of of 6 mg/mL × min and Docetaxel 75 mg/m\^2, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.

Carboplatin + Docetaxel

Participants received IV dose of Cisplatin 80 mg/m\^2 on Day 1 of each 21-day cycle and Gemcitabine 1000-1250 mg/m\^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.

Cisplatin + Gemcitabine

Included participants who received Cisplatin + Docetaxel or Cisplatin + vinorelbine, participants who received only one of the two chemotherapies planned followed by Bevacizumab of each 21-day cycle up to 4 cycles.

Other

Safety-evaluable enrolled participants: All participants who enrolled and received at least one dose of chemotherapy or Bevacizumab. N= Number of participants analyzed.

Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase

Hypertension

Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed.

Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase

Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed. At the time of the 28 January 2009 data cutoff, an additional 25 patients had been randomized.

Number of Participants With Any Adverse Events During Post-Chemotherapy Phase

Adverse Event

Concomitant/ancillary therapy

Patient's Decision to Discontinue

Investigator's Decision

Unwillingness or inability to comply with study

Unrelated intercurrent illness

Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m\^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.

Enrolled participants: All participants who were enrolled in the study. N= Number of participants analyzed.

Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase

Bevacizumab: AE

Bevacizumab: Concomitant/ancillary therapy

Bevacizumab: Patient's Decision to Discontinue

Bevacizumab: Investigator's Decision

Bevacizumab: Unwillingness or inability to comply

Bevacizumab: Unrelated intercurrent illness

Bevacizumab: Sponsor's decision

Bevacizumab: Lost to follow-up

Erlotinib/placebo: AE

Erlotinib/placebo: Concomitant/ancillary therapy

Erlotinib/placebo:Patient's Decision

Erlotinib/placebo: Investigator's Decision

Erlotinib/placebo:Unwillingness/inability comply

Erlotinib/placebo: Unrelated intercurrent illness

Erlotinib/placebo: Sponsor's decision

Erlotinib/placebo: Lost to follow-up

Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib.

orally daily.

Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase.. N= Number of participants analyzed.

Incidence of Study Treatment Discontinuation

Intent-to-treat population included all participants who were randomized during the post-chemotherapy phase.

Overall Survival

Participants received one of six chemotherapy regimens (Carboplatin + Paclitaxel or Carboplatin + Gemcitabine or Carboplatin + Docetaxel or Cisplatin + Gemcitabine or Cisplatin + Docetaxel / Cisplatin + vinorelbine) followed by Bevacizumab on Day 1 of each cycle up to 4 cycles.

Bevacizumab + Chemotherapy

Chemotherapy Phase

Post Chemotherapy Phase

Pharmaceutical Solutions

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.

FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie).

2-deoxy-2-[18F]fluoro-D-glucose (FDG)

FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection.

3'-deoxy-3'-[18F]fluorothymidine (FLT)

Bernard Fine, M.D.

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 non-small cell lung cancer (NSCLC). The study will enroll approximately 30 patients at approximately 4 sites in Australia and 2 sites in the United States.

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

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

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 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.

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%.

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 (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 (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 (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 (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.

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.

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.

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.

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.

The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET.

Roche Pharma AG

Includes evaluation of all Safety-Evaluable Patients \[n = 85\].

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. FDG-PET intravenous injection-dosage based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose of 7 mCi.

Erlotinib

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.

Patients who were treated with any dose of erlotinib were included in the summary of baseline measures.

Medical Communications

The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG Responders would have prolonged PFS compared with FDG Non-Responders.

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.

FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group.

Erlotinib_FDG Responders

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.

FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group.

Erlotinib_ FDG Non-Responders

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.

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

Day 14 response

Day 56 response

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.

FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi.

FDG-Evaluable patients. Participants who were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.

Percentage of Patients With FDG-PET Responses

The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have a prolonged PFS compared to FDG Progressive Disease.

Erlotinib_FDG Responders With CT SD at Day 56

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.

FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had Progressive disease on FDG-PET scans at Day 56 were included in this group.

Erlotinib_FDG Progressive Disease With CT SD at Day 56

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.

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

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.

FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi.

FLT-Evaluable Patients. Participants who were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.

Percentage of Patients With FLT-PET Responses

The null hypothesis is that there is no difference in PFS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged PFS compared with FLT Non-Responders.

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.

FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group.

Erlotinib_FLT Responders

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.

FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who did not have CR/PR on FLT-PET scans at Day 56 were included in this group.

Erlotinib_ FLT Non-Responders

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.

Progression Free Survival of Groups by FLT Response at Day 56

The null hypothesis is that there is no difference between FLT Responders and FLT Progressive Disease. Alternative hypothesis is that FLT responders would have prolonged PFS compared to FLT Progressive Disease.

Erlotinib_FLT Responders With CT SD at Day 56

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.

FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had Progressive disease on FLT-PET scans at Day 56 were included in this group.

Erlotinib_FLT Progressive Disease With CT SD at Day 56

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.

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

The null hypothesis is that there is no difference in OS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG responders would have prolonged OS compared with FDG Non-Responders.

Erlotinib_ FDG Non-Responder

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 last date patients known to be alive.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors	NCT00975182	Non-Squamous No...	GDC-0941 erlotinib HCl	18 Years -	Genentech, Inc.
A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer	NCT00130728	Non-Small Cell ...	bevacizumab erlotinib HCl placebo	18 Years -	Genentech, Inc.
A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)	NCT00257608	Non-Small Cell ...	bevacizumab placebo erlotinib HCl	18 Years -	Genentech, Inc.
A Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib	NCT00453362	Non-Small Cell ...	2-deoxy-2-[18F]... 3'-deoxy-3'-[18... erlotinib HCl	18 Years -	Genentech, Inc.
A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)	NCT00854308	Non-Small Cell ...	Erlotinib HCl MetMAb placebo (0.9 % ...	18 Years -	Genentech, Inc.
A Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib	NCT00453362	Non-Small Cell ...	2-deoxy-2-[18F]... 3'-deoxy-3'-[18... erlotinib HCl	18 Years -	Genentech, Inc.
A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer	NCT00130728	Non-Small Cell ...	bevacizumab erlotinib HCl placebo	18 Years -	Genentech, Inc.

Spots Global Cancer Trial Database for erlotinib hcl