Trial · NCT00789373
A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer
NCT00789373, Phase 3, Completed, Eli Lilly and Company; results first posted 2011-07-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer. Trials, record NCT00789373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00789373
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer
- NCT number
- NCT00789373
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 939 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Pemetrexed, Cisplatin, Placebo, Pemetrexed, Best Supportive Care
- First posted
- 2008-11-11
- Last updated
- 2018-12-14
- Results first posted
- 2011-07-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator-assessed Objective Progression-free Survival (PFS) | Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months) | Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions. |
| Secondary | Independently-assessed Objective Progression-free Survival (PFS) | Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months) | To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions. |
| Secondary | Overall Survival (OS) | Date of randomization to the date of death from any cause up to 39.5 months | OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact. |
| Secondary | Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score | Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months) | The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). |
| Secondary | Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS) | Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months) | Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Secondary | Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization) | Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months) | |
| Secondary | Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase | Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months) | A summary of non-serious AEs is located in the Reported Adverse Event Module. |
| Secondary | Percentage of Participants With Serious Adverse Events During Maintenance Phase | Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months) | A summary of serious adverse events is located in the Reported Adverse Event Module. |
| Secondary | Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off | Baseline to date of measured progressive disease (up to 19.3 months) | Analysis for combined phases was not performed since response was calculated separately for each phase of study. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response(PR)is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease(PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease(SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD. |
| Secondary | Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off | Date of randomization to date of measured PD (up to 19.3 months) | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD. Response Rate = (CR+PR)/Participants in Arm\*100. Disease Control Rate=(CR+PR+SD)/Number of Participants in Arm\*100. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigator-assessed Objective Progression-free Survival (PFS) | Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months) | All randomized participants | months | MEDIAN |
| SECONDARY | Independently-assessed Objective Progression-free Survival (PFS) | Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months) | Randomized participants with reviewable scan--(316/359 \[88%\] Maintenance arm and 156/180 \[87%\] Placebo comparator arm. The majority of unread scans (12.4%) were due to participants not completing 1 cycle of treatment by the data cutoff date (30 June 2010). | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Date of randomization to the date of death from any cause up to 39.5 months | All randomized participants. In the Pemetrexed maintenance arm 103 (28.7%) participants were censored and in the Placebo maintenance arm 39 (21.7%) participants were censored. | months | MEDIAN |
| SECONDARY | Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score | Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months) | Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS) | Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months) | Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization) | Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months) | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase | Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months) | Randomized population with 2% cut-off threshold for inclusion for 19.3 months and 5% for 49.7 months. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serious Adverse Events During Maintenance Phase | Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months) | Randomized population with all serious adverse events included. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off | Baseline to date of measured progressive disease (up to 19.3 months) | All randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off | Date of randomization to date of measured PD (up to 19.3 months) | All randomized participants | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group106
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Investigator-assessed Objective Progression-free Survival (PFS) | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | 4.11 | 95% Confidence Interval 3.15 to 4.57 | months | |
| Investigator-assessed Objective Progression-free Survival (PFS) | Pemetrexed + Cisplatin Followed by Placebo | 2.83 | 95% Confidence Interval 2.60 to 3.12 | months | |
| Independently-assessed Objective Progression-free Survival (PFS) | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | 3.94 | 95% Confidence Interval 2.96 to 4.24 | months | |
| Independently-assessed Objective Progression-free Survival (PFS) | Pemetrexed + Cisplatin Followed by Placebo | 2.60 | 95% Confidence Interval 2.23 to 2.92 | months | |
| Overall Survival (OS) | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | 13.86 | 95% Confidence Interval 12.75 to 16.03 | months | |
| Overall Survival (OS) | Pemetrexed + Cisplatin Followed by Placebo | 11.01 | 95% Confidence Interval 9.95 to 12.52 | months | |
| Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | Baseline | 0.77 | Standard Deviation 0.21 | units on a scale |
| Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score | Pemetrexed + Cisplatin Followed by Placebo | Baseline | 0.79 | Standard Deviation 0.18 | units on a scale |
| Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | Cycle 1 Day 1 | 0.01 | Standard Deviation 0.15 | units on a scale |
| Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score | Pemetrexed + Cisplatin Followed by Placebo | Cycle 1 Day 1 | -0.01 | Standard Deviation 0.17 | units on a scale |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction | STARTED | Induction Pemetrexed + Cisplatin | 939 | |
| Induction | STARTED | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | 0 | |
| Induction | STARTED | Pemetrexed + Cisplatin Followed by Placebo | 0 | |
| Induction | COMPLETED | Induction Pemetrexed + Cisplatin | 540 | |
| Induction | COMPLETED | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | 0 | |
| Induction | COMPLETED | Pemetrexed + Cisplatin Followed by Placebo | 0 | |
| Induction | NOT COMPLETED | Induction Pemetrexed + Cisplatin | 399 | |
| Induction | NOT COMPLETED | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | 0 | |
| Induction | NOT COMPLETED | Pemetrexed + Cisplatin Followed by Placebo | 0 | |
| Maintenance | STARTED | Induction Pemetrexed + Cisplatin | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events741
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 | Induction Pemetrexed + Cisplatin | 152 | 939 | 600 |
| other | Anaemia | Blood and lymphatic system disorders | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | 76 | 359 | 295 |
| other | Anaemia | Blood and lymphatic system disorders | Pemetrexed + Cisplatin Followed by Placebo | 5 | 180 | 11 |
| other | Neutropenia | Blood and lymphatic system disorders | Induction Pemetrexed + Cisplatin | 158 | 939 | 340 |
| other | Neutropenia | Blood and lymphatic system disorders | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | 38 | 359 | 100 |
| other | Neutropenia | Blood and lymphatic system disorders | Pemetrexed + Cisplatin Followed by Placebo | 3 | 180 | 4 |
| other | Constipation | Gastrointestinal disorders | Induction Pemetrexed + Cisplatin | 131 | 939 | 339 |
| other | Constipation | Gastrointestinal disorders | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | 23 | 359 | 110 |
| other | Constipation | Gastrointestinal disorders | Pemetrexed + Cisplatin Followed by Placebo | 14 | 180 | 47 |
| other | Diarrhoea | Gastrointestinal disorders | Induction Pemetrexed + Cisplatin | 114 | 939 | 175 |
1 to 10 of 741Source ClinicalTrials.gov
See all 741 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction Pemetrexed + Cisplatin | ||
| Total, all-cause mortality | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | ||
| Total, all-cause mortality | Pemetrexed + Cisplatin Followed by Placebo | ||
| Total, other adverse events | Induction Pemetrexed + Cisplatin | 759 | 939 |
| Total, other adverse events | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | 287 | 359 |
| Total, other adverse events | Pemetrexed + Cisplatin Followed by Placebo | 117 | 180 |
| Total, serious adverse events | Induction Pemetrexed + Cisplatin | 257 | 939 |
| Total, serious adverse events | Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed | 94 | 359 |
| Total, serious adverse events | Pemetrexed + Cisplatin Followed by Placebo | 36 | 180 |
Source ClinicalTrials.gov
Papers8
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00789373
GET https://conductscience.org/api/trials/v1/NCT00789373/results?page=2