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← PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND: metastatic Non-small cell lung cancer (first-line)

NCT01139775 · STUDY IN CONTEXT

A Study in Non Small Cell Lung Cancer

Draft scope assessment: unclear. Attached because the study's own record 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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Progression-free survival (PFS) time is defined as the time from the date of randomization to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.

All randomized Phase 2 participants.

→

primary · POSTED

The recommended Phase 2 dose for LY2603618 when administered approximately 24 hours after pemetrexed and cisplatin was based on the maximum tolerated dose (MTD) and achievement of predefined LY2603618 plasma systemic exposures targets (area under the LY2603618 plasma concentration versus time curve from time zero to infinity \[AUC(0-∞)\] \>21,000 nanogram\*hour/milliliter \[ng\*h/mL\] and maximum LY2603618 plasma concentration \[Cmax\] \>2000 nanograms/milliliter \[ng/mL\]).

Phase 1 participants who received at least 1 dose of any of the study drugs.

→

secondary · POSTED

Overall survival (OS) time is defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.

All randomized Phase 2 participants.

→

secondary · POSTED

Overall response rate is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.

All randomized Phase 2 participants.

→

secondary · POSTED

Change in tumor size was based on tumor measurements collected according to RECIST, v1.1 guidelines. Tumor size is the sum of the tumor measurements (longest diameters) of target lesions at each tumor evaluation. Change in tumor size was defined as the change in log tumor size from baseline evaluation to the evaluation at the end of Cycle 2.

Participants with measureable disease (target lesions) at baseline who received at least 1 dose of study drug.

→

secondary · POSTED

Cmax is reported for each LY2603618 dose level on Cycle 1 /Day 2 and Cycle 2 /Day 2. The number of pharmacokinetic observations (n) used in the analysis is presented for each dose level and time point.

Phase 1 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.

→

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 · Phase 2: Change From Baseline to Long-term Follow up in 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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT01139775
qol key
qol-0011
source section id
NCT01139775-om-0011
source outcome index
11
instrument
Unnamed quality-of-life measure
instrument basis
matched 'health-related quality' in the study's own wording
scale title
Phase 2: Change From Baseline to Long-term Follow up in Lung Cancer Symptom Scale (LCSS)
measure definition
Health-related quality of life and participant symptoms were assessed using the LCSS (patient scale). However, improper implementation of questionnaires at the site level reduced the sponsor's ability to accurately evaluate the impacted data. Therefore, the LCSS data should be interpreted with caution. The LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. Scores range from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was calculated as the mean of 6 symptom-specific questions from the LCSS. The total LCSS score was calculated as the mean of 9 questions from the LCSS.
time frame
Randomization to the end of study (approximately 12 months after the last participant entered treatment)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All enrolled Phase 2 participants who had the baseline LCSS assessment and at least 1 post-baseline assessment.
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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
nct id
NCT01139775
trial label
A Study in Non Small Cell Lung Cancer
applicability
unclear
applicability note
Attached because the study's own record 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
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
3
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0000
    source section id
    NCT01139775-om-0000
    source outcome index
    0
    endpoint
    Phase 2: Progression-Free Survival Time
    endpoint definition
    Progression-free survival (PFS) time is defined as the time from the date of randomization to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.
    time origin
    Randomization up to first date of PD or death from any cause (up to 6 months after the last participant entered treatment)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized Phase 2 participants.
    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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0001
    source section id
    NCT01139775-om-0001
    source outcome index
    1
    endpoint
    Phase 1: Recommended Phase 2 Dose of LY2603618
    endpoint definition
    The recommended Phase 2 dose for LY2603618 when administered approximately 24 hours after pemetrexed and cisplatin was based on the maximum tolerated dose (MTD) and achievement of predefined LY2603618 plasma systemic exposures targets (area under the LY2603618 plasma concentration versus time curve from time zero to infinity \[AUC(0-∞)\] \>21,000 nanogram\*hour/milliliter \[ng\*h/mL\] and maximum LY2603618 plasma concentration \[Cmax\] \>2000 nanograms/milliliter \[ng/mL\]).
    time origin
    Time of first dose to last dose
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Phase 1 participants who received at least 1 dose of any of the study drugs.
    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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0002
    source section id
    NCT01139775-om-0002
    source outcome index
    2
    endpoint
    Phase 2: Overall Survival
    endpoint definition
    Overall survival (OS) time is defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.
    time origin
    Randomization to the date of death from any cause through the time of study discontinuation (approximately 12 months after last participant was randomized)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized Phase 2 participants.
    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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0003
    source section id
    NCT01139775-om-0003
    source outcome index
    3
    endpoint
    Phase 2: Overall Tumor Response Rate: Percentage of Participants Who Achieved a Confirmed Best Response of Completed Response (CR) or Partial Response (PR)
    endpoint definition
    Overall response rate is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
    time origin
    Randomization until date of disease progression (up to 6 months after the last participant was randomized)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized Phase 2 participants.
    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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0004
    source section id
    NCT01139775-om-0004
    source outcome index
    4
    endpoint
    Phase 2: Change in Tumor Size
    endpoint definition
    Change in tumor size was based on tumor measurements collected according to RECIST, v1.1 guidelines. Tumor size is the sum of the tumor measurements (longest diameters) of target lesions at each tumor evaluation. Change in tumor size was defined as the change in log tumor size from baseline evaluation to the evaluation at the end of Cycle 2.
    time origin
    Baseline, end of Cycle 2
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants with measureable disease (target lesions) at baseline who received at least 1 dose of study drug.
    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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0005
    source section id
    NCT01139775-om-0005
    source outcome index
    5
    endpoint
    Phase 1: Pharmacokinetic: Maximum Plasma Concentration (Cmax) (LY2603618)
    endpoint definition
    Cmax is reported for each LY2603618 dose level on Cycle 1 /Day 2 and Cycle 2 /Day 2. The number of pharmacokinetic observations (n) used in the analysis is presented for each dose level and time point.
    time origin
    Cycle 1/Day 2 - immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose; Cycle 2/Day 2 - predose, immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Phase 1 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.
    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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Phase 2: Pemetrexed + Cisplatin + LY2603618
    regimen
    Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    analyzed count
    39
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01139775-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Phase 2: Pemetrexed + Cisplatin
    regimen
    Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01139775-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Phase 1: Pemetrexed + Cisplatin + LY2603618
    regimen
    Cycles 1-2 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 130 to 275 mg After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01139775-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Phase 2: Pemetrexed + Cisplatin + LY2603618
    regimen
    Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    analyzed count
    39
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01139775-om-0002#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Phase 2: Pemetrexed + Cisplatin
    regimen
    Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01139775-om-0002#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Phase 2: Pemetrexed + Cisplatin + LY2603618
    regimen
    Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    analyzed count
    39
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01139775-om-0003#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Phase 2: Pemetrexed + Cisplatin
    regimen
    Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01139775-om-0003#groups/OG001
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Phase 2: Pemetrexed + Cisplatin + LY2603618
    regimen
    Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    analyzed count
    39
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01139775-om-0004#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Phase 2: Pemetrexed + Cisplatin
    regimen
    Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.
    analyzed count
    22
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01139775-om-0004#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Phase 1: Pemetrexed + Cisplatin + LY2603618
    regimen
    Cycles 1-2 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 130 to 275 mg After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01139775-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    harm key
    EG000
    source section id
    NCT01139775-ae
    event group key
    EG000
    event group label
    Phase 1: Pemetrexed + Cisplatin + LY2603618
    serious affected
    1
    serious at risk
    14
    other affected
    14
    other at risk
    14
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    harm key
    EG001
    source section id
    NCT01139775-ae
    event group key
    EG001
    event group label
    Phase 2: Pemetrexed + Cisplatin + LY2603618
    serious affected
    16
    serious at risk
    39
    other affected
    37
    other at risk
    39
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    harm key
    EG002
    source section id
    NCT01139775-ae
    event group key
    EG002
    event group label
    Phase 2: Pemetrexed + Cisplatin
    serious affected
    6
    serious at risk
    22
    other affected
    22
    other at risk
    22
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    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-paclitaxel-protein-bound-particles-albumin-bound-eb290623
    nct id
    NCT01139775
    qol key
    qol-0011
    source section id
    NCT01139775-om-0011
    source outcome index
    11
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'health-related quality' in the study's own wording
    scale title
    Phase 2: Change From Baseline to Long-term Follow up in Lung Cancer Symptom Scale (LCSS)
    measure definition
    Health-related quality of life and participant symptoms were assessed using the LCSS (patient scale). However, improper implementation of questionnaires at the site level reduced the sponsor's ability to accurately evaluate the impacted data. Therefore, the LCSS data should be interpreted with caution. The LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. Scores range from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was calculated as the mean of 6 symptom-specific questions from the LCSS. The total LCSS score was calculated as the mean of 9 questions from the LCSS.
    time frame
    Randomization to the end of study (approximately 12 months after the last participant entered treatment)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All enrolled Phase 2 participants who had the baseline LCSS assessment and at least 1 post-baseline assessment.
    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