Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR

Draft scope assessment: unclear. Attached because the study's own record names EGFR. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)

Source null

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secondary · POSTED

The objective response rate is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response will be evaluated following RECIST criteria version 1.0. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on study.

Source null

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secondary · POSTED

Overall Survival (OS) is defined as the time, in months, from the inclusion date to the death date. A patient is censored at the last contact date if he/she does not die.Overall survival will be assessed from the date of enrollment in the study until the date of death from any cause. Patients lost to follow-up will be censured on the date of the last follow-up visit.

Source null

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secondary · POSTED

The study of mutations in serum (serum DNA). This exploratory analysis was performed to determine whether EGFR mutations can reliably be detected in serum thereby reducing the requirement for invasive techniques as well as to enable detection of mutations in patients where no tumor biopsy samples are available.

Intention to treat. Serum sample taken at baseline

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id: NCT00446225
trial label: Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR
applicability: unclear
applicability note: Attached because the study's own record names EGFR. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
outcome key
om-0000
source section id
NCT00446225-om-0000
source outcome index
0
endpoint
Progression Free-survival
endpoint definition
The time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)
time origin
From the date of randomization to the date of last follow up, assessed up to 24 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
outcome key
om-0001
source section id
NCT00446225-om-0001
source outcome index
1
endpoint
Objective Response
endpoint definition
The objective response rate is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response will be evaluated following RECIST criteria version 1.0. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on study.
time origin
From the date of randomization to the date of last follow up, assessed up to 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
outcome key
om-0002
source section id
NCT00446225-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
Overall Survival (OS) is defined as the time, in months, from the inclusion date to the death date. A patient is censored at the last contact date if he/she does not die.Overall survival will be assessed from the date of enrollment in the study until the date of death from any cause. Patients lost to follow-up will be censured on the date of the last follow-up visit.
time origin
From the date of randomization to the date of last follow up, assessed up to 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
outcome key
om-0003
source section id
NCT00446225-om-0003
source outcome index
3
endpoint
Molecular Markers Related to EGFR and Study Pathology
endpoint definition
The study of mutations in serum (serum DNA). This exploratory analysis was performed to determine whether EGFR mutations can reliably be detected in serum thereby reducing the requirement for invasive techniques as well as to enable detection of mutations in patients where no tumor biopsy samples are available.
time origin
At baseline
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intention to treat. Serum sample taken at baseline
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
outcome key
om-0000
arm key
OG000
arm label
A: Erlotinib Group
regimen
Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
analyzed count
86
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00446225-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
outcome key
om-0000
arm key
OG001
arm label
B: Standard Chemotherapy Group
regimen
4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy * 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or * 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: * 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or * 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
analyzed count
87
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00446225-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
outcome key
om-0001
arm key
OG000
arm label
A: Erlotinib Group
regimen
Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
analyzed count
86
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00446225-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
outcome key
om-0001
arm key
OG001
arm label
B: Standard Chemotherapy Group
regimen
4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy * 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or * 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: * 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or * 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
analyzed count
87
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00446225-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
outcome key
om-0002
arm key
OG000
arm label
A: Erlotinib Group
regimen
Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
analyzed count
86
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00446225-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
outcome key
om-0002
arm key
OG001
arm label
B: Standard Chemotherapy Group
regimen
4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy * 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or * 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: * 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or * 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
analyzed count
87
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00446225-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
outcome key
om-0003
arm key
OG000
arm label
A: Erlotinib Group
regimen
Erlotinib (Tarceva)150 mg /day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib Erlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity. For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
analyzed count
86
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00446225-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
outcome key
om-0003
arm key
OG001
arm label
B: Standard Chemotherapy Group
regimen
4 cycles of Chemotherapy: Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel. 3 week cycles of standard intravenous chemotherapy * 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or * 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8 Patients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead: * 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or * 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8 Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
analyzed count
87
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00446225-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
harm key
EG000
source section id
NCT00446225-ae
event group key
EG000
event group label
A: Erlotinib Group
serious affected
27
serious at risk
86
other affected
70
other at risk
86
frequency threshold
5
collection period
36 months
event definition
The severity of AE will be determined using CTCAE version 3.0
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-imjudo-bf59e44c
nct id
NCT00446225
harm key
EG001
source section id
NCT00446225-ae
event group key
EG001
event group label
B: Standard Chemotherapy Group
serious affected
25
serious at risk
87
other affected
65
other at risk
87
frequency threshold
5
collection period
36 months
event definition
The severity of AE will be determined using CTCAE version 3.0
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice