Trial · NCT01168973
A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy
NCT01168973, Phase 3, Completed, Eli Lilly and Company; results first posted 2014-12-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy. Trials, record NCT01168973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01168973
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy
- NCT number
- NCT01168973
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,253 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Ramucirumab, Placebo (for Ramucirumab), Docetaxel
- First posted
- 2010-07-23
- Last updated
- 2019-09-25
- Other registries' IDs
- eudract:2010-021297-11
- Results first posted
- 2014-12-29
- Limitations and caveats
Three participants randomized to placebo and docetaxel received 1 dose of ramucirumab in error. They are included in the placebo and docetaxel arm in the ITT population and are included in the ramucirumab and docetaxel arm in the Safety population.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Randomization to date of death from any cause (up to 34 months) | Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive. |
| Secondary | Progression-Free Survival (PFS) Time | Randomization to measured PD or date of death from any cause (up to 29 months) | PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), 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 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization. |
| Secondary | Percentage of Participants Achieving an Objective Response (Objective Response Rate) | Baseline to measured PD (up to 29 months) | Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels \[if tumor markers were initially above the upper limit of normal (ULN)\]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)\*100. |
| Secondary | Percentage of Participants Achieving Disease Control (Disease Control Rate) | Baseline to measured PD (up to 29 months) | Participants achieved disease control if they had a best overall response of PR, CR or stable disease (SD). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN). SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control=(number of participants with CR, PR, or SD)/(number of participants assessed)\*100. |
| Secondary | Maximum Improvement on Lung Cancer Symptom Scale (LCSS) | Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle) | 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 items were 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-mm lines. A higher score for any item represented a higher level of symptoms/problems. The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable. |
| Secondary | Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores | Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle) | The EQ-5D is a quality-of-life instrument that consists of 2 parts. The first part (Health State Index score) allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the EQ-5D was a VAS that allowed participants to rate their present health condition. Possible EQ-5D VAS scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Secondary | Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab | Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle) | |
| Secondary | Number of Participants With Anti-Ramucirumab Antibodies | Baseline, prior to infusion for week 4 and 8 (cycles 3 and 5), and 30 days following last infusion (up to Cycle 38, 21 days/cycle) | The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from baseline through Cycle 5 pre-infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Participants with follow-up emergent ADA were defined as participants who had any sample during 30 days post last infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer. |
| Other | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died | First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle) | Data presented are the number of participants who experienced at least 1 TEAE, Grade 3, 4, or 5 TEAE, treatment-emergent serious adverse event (SAE), TEAE leading to discontinuation of study treatment (ramucirumab/placebo or docetaxel), and TEAE leading to death. Clinically significant events were defined as treatment-emergent SAEs and other non-serious adverse events (AEs) regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Randomization to date of death from any cause (up to 34 months) | Intent-to-Treat (ITT) population: All randomized participants grouped according to their assigned treatment at randomization. Participants censored: ramucirumab and docetaxel arm = 200 participants; placebo and docetaxel arm = 169 participants. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Time | Randomization to measured PD or date of death from any cause (up to 29 months) | ITT population: All randomized participants grouped according to their assigned treatment at randomization. Participants censored: ramucirumab and docetaxel arm = 70 participants; placebo and docetaxel arm = 42 participants. | months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving an Objective Response (Objective Response Rate) | Baseline to measured PD (up to 29 months) | ITT population: All randomized participants grouped according to their assigned treatment at randomization. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Disease Control (Disease Control Rate) | Baseline to measured PD (up to 29 months) | ITT population: All randomized participants grouped according to their assigned treatment at randomization. | percentage of participants | NUMBER |
| SECONDARY | Maximum Improvement on Lung Cancer Symptom Scale (LCSS) | Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle) | Randomized participants grouped according to their assigned treatment at randomization, who had a baseline and at least 1 post-baseline LCSS score. | mm | MEAN |
| SECONDARY | Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores | Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle) | Randomized participants grouped according to their assigned treatment at randomization, who had an EQ-5D assessment at a baseline and 30 days post treatment. | units on a scale | MEAN |
| SECONDARY | Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab | Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle) | Participants assigned to the ramucirumab and docetaxel arm at randomization, who had evaluable ramucirumab pharmacokinetic (PK) data to calculate Cmax and Cmin. | micrograms per milliliter (mcg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Anti-Ramucirumab Antibodies | Baseline, prior to infusion for week 4 and 8 (cycles 3 and 5), and 30 days following last infusion (up to Cycle 38, 21 days/cycle) | Randomized participants who received any quantity of study treatment, grouped by the treatment they actually received, who had a baseline and at least 1 post-baseline ADA assessment. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died | First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle) | Safety population: Randomized participants who received any quantity of study drug, grouped by the treatment they actually received. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Ramucirumab and Docetaxel | 10.5 | 95% Confidence Interval 9.5 to 11.2 | months | |
| Overall Survival | Placebo and Docetaxel | 9.1 | 95% Confidence Interval 8.4 to 10.0 | months | |
| Progression-Free Survival (PFS) Time | Ramucirumab and Docetaxel | 4.5 | 95% Confidence Interval 4.2 to 5.3 | months | |
| Progression-Free Survival (PFS) Time | Placebo and Docetaxel | 3.0 | 95% Confidence Interval 2.8 to 3.9 | months | |
| Percentage of Participants Achieving an Objective Response (Objective Response Rate) | Ramucirumab and Docetaxel | 22.9 | 95% Confidence Interval 19.7 to 26.4 | percentage of participants | |
| Percentage of Participants Achieving an Objective Response (Objective Response Rate) | Placebo and Docetaxel | 13.6 | 95% Confidence Interval 11.0 to 16.5 | percentage of participants | |
| Percentage of Participants Achieving Disease Control (Disease Control Rate) | Ramucirumab and Docetaxel | 64.0 | 95% Confidence Interval 60.1 to 67.8 | percentage of participants | |
| Percentage of Participants Achieving Disease Control (Disease Control Rate) | Placebo and Docetaxel | 52.6 | 95% Confidence Interval 48.6 to 56.6 | percentage of participants | |
| Maximum Improvement on Lung Cancer Symptom Scale (LCSS) | Ramucirumab and Docetaxel | Loss of Appetite (n=473, 471) | -10.9 | Standard Deviation 26.11 | mm |
| Maximum Improvement on Lung Cancer Symptom Scale (LCSS) | Placebo and Docetaxel | Loss of Appetite (n=473, 471) | -11.0 | Standard Deviation 26.22 | mm |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ramucirumab and Docetaxel | 628 | |
| Overall Study | STARTED | Placebo and Docetaxel | 625 | |
| Overall Study | Received Any Quantity of Any Study Drug | Ramucirumab and Docetaxel | 624 | |
| Overall Study | Received Any Quantity of Any Study Drug | Placebo and Docetaxel | 621 | |
| Overall Study | COMPLETED | Ramucirumab and Docetaxel | 15 | |
| Overall Study | COMPLETED | Placebo and Docetaxel | 14 | |
| Overall Study | NOT COMPLETED | Ramucirumab and Docetaxel | 613 | |
| Overall Study | NOT COMPLETED | Placebo and Docetaxel | 611 |
Source ClinicalTrials.gov
Adverse events670
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Ramucirumab and Docetaxel | 135 | 627 | 306 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo and Docetaxel | 174 | 618 | 399 |
| other | Leukopenia | Blood and lymphatic system disorders | Ramucirumab and Docetaxel | 79 | 627 | 259 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo and Docetaxel | 68 | 618 | 151 |
| other | Neutropenia | Blood and lymphatic system disorders | Ramucirumab and Docetaxel | 228 | 627 | 547 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo and Docetaxel | 188 | 618 | 415 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ramucirumab and Docetaxel | 51 | 627 | 114 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo and Docetaxel | 27 | 618 | 48 |
| other | Lacrimation increased | Eye disorders | Ramucirumab and Docetaxel | 85 | 627 | 100 |
| other | Lacrimation increased | Eye disorders | Placebo and Docetaxel | 29 | 618 | 31 |
1 to 10 of 670Source ClinicalTrials.gov
See all 670 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramucirumab and Docetaxel | ||
| Total, all-cause mortality | Placebo and Docetaxel | ||
| Total, other adverse events | Ramucirumab and Docetaxel | 601 | 627 |
| Total, other adverse events | Placebo and Docetaxel | 583 | 618 |
| Total, serious adverse events | Ramucirumab and Docetaxel | 284 | 627 |
| Total, serious adverse events | Placebo and Docetaxel | 281 | 618 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ramucirumab and Docetaxel vs Placebo and Docetaxel: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01168973
GET https://conductscience.org/api/trials/v1/NCT01168973/results?page=2