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← IRESSA: metastatic Non-small cell lung cancer with EGFR stated without a specific alteration (first-line)

NCT02411448 · STUDY IN CONTEXT

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

Draft scope assessment: unclear. Attached because the study's own record names EGFR and describes metastatic disease. 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

PFS is defined as the time from the date of randomization to the date of radiographically documented progressive disease (PD) based on investigator assessment, or the date of death due to any cause, whichever is first assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.

Part B: All randomized participants grouped according to their assigned treatment at randomization. Censored participants were: Part B: Ramucirumab+ Erlotinib= 102 and Part B: Placebo+ Erlotinib= 67. Per protocol, Part A did not evaluate efficacy.

→

primary · POSTED

A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

All randomized participants who received at least one dose of study drug.

→

secondary · POSTED

OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who was not known to have died as of the data-inclusion cutoff date for a particular analysis,OS was censored for that analysis at the date of last contact prior to the data-inclusion cutoff date (contacts considered in the determination of last contact date include adverse event (AE) date, lesion assessment date, visit date, and last known alive date).

Part B: All randomized participants grouped according to their assigned treatment at randomization. Censored participants were: Part B: Ramucirumab+ Erlotinib= 187 and Part B: Placebo+ Erlotinib= 183. Per protocol, Part A did not evaluate efficacy.

→

secondary · POSTED

ORR was defined as the percentage of randomized participants achieving a best overall response of partial response (PR) or complete response (CR) assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to \<10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.

Part B: All randomized participants grouped according to their assigned treatment at randomization. Per protocol, Part A did not evaluate efficacy.

→

secondary · POSTED

DCR was defined as the percentage of randomized participants achieving a best overall response of CR,PR, or stable disease(SD) assessed via Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1. CR was defined as the disappearance of all lesions,pathological lymph node reduction in short axis to \<10 mm, and normalization of tumor marker levels of non-target lesions.PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease(PD) was at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.

Part B: All randomized participants grouped according to their assigned treatment at randomization. Per protocol, Part A did not evaluate efficacy.

→

secondary · POSTED

DoR was defined as the date of first documented CR or PR (responder) to the date of progressive disease or the date of death due to any cause, whichever was earlier. If a responder was not known to have died or have progressive disease, then the participant was censored at the date of last evaluable tumor assessment.CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to \<10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.

Part B: All randomized participants grouped according to their assigned treatment at randomization that had a response (CR or PR). Per protocol, Part A did not evaluate efficacy.

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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

Unnamed quality-of-life measure · Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02411448
qol key
qol-0008
source section id
NCT02411448-om-0008
source outcome index
8
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS)
measure definition
The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\] and 3 global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-millimeter (mm) lines. A higher score for any item represented a higher level of symptoms/problems. The LCSS total score was defined as the mean of all 9 items. Average symptom burden index (ASBI) was calculated as the mean of the six symptom-specific questions from the LCSS. Potential scores range from 0 (for best outcome) to 100 (for worst outcome).
time frame
Baseline, End of Study (Up To 37 Months)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Part B: All randomized participants who completed the LCSS at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02411448
qol key
qol-0009
source section id
NCT02411448-om-0009
source outcome index
9
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
measure definition
The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
time frame
Baseline, Cycle 10 (each cycle is 2 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02411448
qol key
qol-0010
source section id
NCT02411448-om-0010
source outcome index
10
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
measure definition
The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
time frame
Baseline, Cycle 28 (each cycle is 2 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02411448
qol key
qol-0011
source section id
NCT02411448-om-0011
source outcome index
11
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
measure definition
The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
time frame
Baseline, Cycle 40 (each cycle is 2 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-iressa-7aece853
nct id
NCT02411448
trial label
A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
applicability
unclear
applicability note
Attached because the study's own record names EGFR and describes metastatic disease. 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
6
harms Count
3
qol Count
4
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0000
    source section id
    NCT02411448-om-0000
    source outcome index
    0
    endpoint
    Part B: Progression Free Survival (PFS)
    endpoint definition
    PFS is defined as the time from the date of randomization to the date of radiographically documented progressive disease (PD) based on investigator assessment, or the date of death due to any cause, whichever is first assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
    time origin
    Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Part B: All randomized participants grouped according to their assigned treatment at randomization. Censored participants were: Part B: Ramucirumab+ Erlotinib= 102 and Part B: Placebo+ Erlotinib= 67. Per protocol, Part A did not evaluate efficacy.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0001
    source section id
    NCT02411448-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Treatment-Emergent Adverse Events
    endpoint definition
    A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
    time origin
    Cycle 1 Day 1 through End of Study (Up To 3 Years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants who received at least one dose of study drug.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0002
    source section id
    NCT02411448-om-0002
    source outcome index
    2
    endpoint
    Part B: Overall Survival (OS)
    endpoint definition
    OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who was not known to have died as of the data-inclusion cutoff date for a particular analysis,OS was censored for that analysis at the date of last contact prior to the data-inclusion cutoff date (contacts considered in the determination of last contact date include adverse event (AE) date, lesion assessment date, visit date, and last known alive date).
    time origin
    Randomization to Date of Death from Any Cause (Up To 37 Months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Part B: All randomized participants grouped according to their assigned treatment at randomization. Censored participants were: Part B: Ramucirumab+ Erlotinib= 187 and Part B: Placebo+ Erlotinib= 183. Per protocol, Part A did not evaluate efficacy.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0003
    source section id
    NCT02411448-om-0003
    source outcome index
    3
    endpoint
    Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
    endpoint definition
    ORR was defined as the percentage of randomized participants achieving a best overall response of partial response (PR) or complete response (CR) assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to \<10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
    time origin
    Randomization to Progressive Disease (Up To 37 Months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Part B: All randomized participants grouped according to their assigned treatment at randomization. Per protocol, Part A did not evaluate efficacy.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0004
    source section id
    NCT02411448-om-0004
    source outcome index
    4
    endpoint
    Part B: Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR])
    endpoint definition
    DCR was defined as the percentage of randomized participants achieving a best overall response of CR,PR, or stable disease(SD) assessed via Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1. CR was defined as the disappearance of all lesions,pathological lymph node reduction in short axis to \<10 mm, and normalization of tumor marker levels of non-target lesions.PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease(PD) was at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.
    time origin
    Randomization to Progressive Disease (Up To 37 Months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Part B: All randomized participants grouped according to their assigned treatment at randomization. Per protocol, Part A did not evaluate efficacy.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0005
    source section id
    NCT02411448-om-0005
    source outcome index
    5
    endpoint
    Part B: Duration of Response (DoR)
    endpoint definition
    DoR was defined as the date of first documented CR or PR (responder) to the date of progressive disease or the date of death due to any cause, whichever was earlier. If a responder was not known to have died or have progressive disease, then the participant was censored at the date of last evaluable tumor assessment.CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to \<10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.
    time origin
    Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 37 Months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Part B: All randomized participants grouped according to their assigned treatment at randomization that had a response (CR or PR). Per protocol, Part A did not evaluate efficacy.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Part B: Ramucirumab+ Erlotinib
    regimen
    Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    224
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02411448-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Part B: Placebo+ Erlotinib
    regimen
    Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02411448-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Part A: Ramucirumab + Erlotinib
    regimen
    Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02411448-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Part B: Ramucirumab + Erlotinib
    regimen
    Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    221
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02411448-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Part B: Placebo + Erlotinib
    regimen
    Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02411448-om-0001#groups/OG002
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Part B: Ramucirumab+ Erlotinib
    regimen
    Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    224
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02411448-om-0002#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Part B: Placebo+ Erlotinib
    regimen
    Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02411448-om-0002#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Part B: Ramucirumab+ Erlotinib
    regimen
    Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    224
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02411448-om-0003#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Part B: Placebo+ Erlotinib
    regimen
    Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02411448-om-0003#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Part B: Ramucirumab+ Erlotinib
    regimen
    Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    224
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02411448-om-0004#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Part B: Placebo+ Erlotinib
    regimen
    Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02411448-om-0004#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Part B: Ramucirumab+ Erlotinib
    regimen
    Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    analyzed count
    171
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02411448-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    harm key
    EG000
    source section id
    NCT02411448-ae
    event group key
    EG000
    event group label
    Part A: Ramucirumab + Erlotinib
    serious affected
    0
    serious at risk
    14
    other affected
    14
    other at risk
    14
    frequency threshold
    5
    collection period
    Up To 3 Years
    event definition
    Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants. Part C data will be reported after study completion. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    harm key
    EG001
    source section id
    NCT02411448-ae
    event group key
    EG001
    event group label
    Part B: Ramucirumab + Erlotinib
    serious affected
    65
    serious at risk
    221
    other affected
    220
    other at risk
    221
    frequency threshold
    5
    collection period
    Up To 3 Years
    event definition
    Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants. Part C data will be reported after study completion. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    harm key
    EG002
    source section id
    NCT02411448-ae
    event group key
    EG002
    event group label
    Part B: Placebo + Erlotinib
    serious affected
    47
    serious at risk
    225
    other affected
    225
    other at risk
    225
    frequency threshold
    5
    collection period
    Up To 3 Years
    event definition
    Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants. Part C data will be reported after study completion. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    qol key
    qol-0008
    source section id
    NCT02411448-om-0008
    source outcome index
    8
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS)
    measure definition
    The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\] and 3 global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-millimeter (mm) lines. A higher score for any item represented a higher level of symptoms/problems. The LCSS total score was defined as the mean of all 9 items. Average symptom burden index (ASBI) was calculated as the mean of the six symptom-specific questions from the LCSS. Potential scores range from 0 (for best outcome) to 100 (for worst outcome).
    time frame
    Baseline, End of Study (Up To 37 Months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Part B: All randomized participants who completed the LCSS at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    qol key
    qol-0009
    source section id
    NCT02411448-om-0009
    source outcome index
    9
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
    measure definition
    The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
    time frame
    Baseline, Cycle 10 (each cycle is 2 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    qol key
    qol-0010
    source section id
    NCT02411448-om-0010
    source outcome index
    10
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
    measure definition
    The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
    time frame
    Baseline, Cycle 28 (each cycle is 2 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-iressa-7aece853
    nct id
    NCT02411448
    qol key
    qol-0011
    source section id
    NCT02411448-om-0011
    source outcome index
    11
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
    measure definition
    The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.
    time frame
    Baseline, Cycle 40 (each cycle is 2 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice