Trial · NCT00762034
A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous Non-Small Cell Lung Cancer
NCT00762034, Phase 3, Completed, Eli Lilly and Company; results first posted 2013-11-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous Non-Small Cell Lung Cancer. Trials, record NCT00762034. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00762034
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous Non-Small Cell Lung Cancer
- NCT number
- NCT00762034
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 939 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Pemetrexed, Pemetrexed, Paclitaxel, Carboplatin, Bevacizumab, Bevacizumab
- First posted
- 2008-09-30
- Last updated
- 2015-12-21
- Results first posted
- 2013-11-28
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Baseline to date of death from any cause (up to 37.06 months) | Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive. |
| Secondary | Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate) | Baseline to measured progressive disease (up to 37.06 months) | Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions. |
| Secondary | Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate) | Baseline to measured progressive disease (up to 37.06 months) | Disease Control Rate (DCR) is the number of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared with baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions compared with the smallest sum of the longest diameter recorded since the start of treatment or the appearance of 1 or more new lesion(s). Stable Disease (SD) was defined as small changes that did not meet above criteria. |
| Secondary | Progression Free Survival Time | Baseline to measured progressive disease or date of death from any cause (up to 33.54 months) | Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier. |
| Secondary | Time to Progressive Disease | Baseline to measured progressive disease (up to 37.06 months) | Time to progressive disease was defined as the time from randomization to the first date of objective disease progression. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier. |
| Secondary | Safety and Toxicity Profile of Study Treatments | Baseline to study endpoint (up to 37.06 months) | Safety and toxicity profile was defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module. |
| Secondary | Duration of Hospitalizations Per Participant | Baseline to study endpoint (up to 37.06 months) | Length of hospitalization in participants hospitalized during the study or within 30 days of discontinuation regardless of whether the hospitalization was or was not due to study drug. |
| Secondary | Number of Participants Who Received a Transfusion | Baseline to study endpoint (up to 37.06 months) | |
| Secondary | Number of Participants Receiving Concomitant Medication | Baseline to study endpoint (up to 37.06 months) | |
| Secondary | Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G) | Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days) | The FACT-G is a validated instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item questionnaire and is organized into subscales, each designed to assess a QOL domain: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT-G Total is the sum of the scores of all 4 subscales and ranges from 0 to 108. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Baseline to date of death from any cause (up to 37.06 months) | All randomized participants using the intent-to-treat principle. Number of participants censored: n=131, 127 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively. | months | MEDIAN |
| SECONDARY | Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate) | Baseline to measured progressive disease (up to 37.06 months) | All randomized participants using the intent-to-treat principle | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate) | Baseline to measured progressive disease (up to 37.06 months) | All randomized participants using the intent-to-treat principle | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival Time | Baseline to measured progressive disease or date of death from any cause (up to 33.54 months) | All randomized participants using the intent-to-treat principle. Number of participants censored: n=127, 109 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively. | months | MEDIAN |
| SECONDARY | Time to Progressive Disease | Baseline to measured progressive disease (up to 37.06 months) | All randomized participants using the intent-to-treat principle. Number of participants censored: n=198, 172 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively. | months | MEDIAN |
| SECONDARY | Safety and Toxicity Profile of Study Treatments | Baseline to study endpoint (up to 37.06 months) | All randomized participants who received at least 1 dose of study drug during the specified treatment phase. | participants | NUMBER |
| SECONDARY | Duration of Hospitalizations Per Participant | Baseline to study endpoint (up to 37.06 months) | All randomized participants who received at least 1 dose of study drug and had at least one hospitalization while on study or within 30 days of discontinuation. | days | MEAN |
| SECONDARY | Number of Participants Who Received a Transfusion | Baseline to study endpoint (up to 37.06 months) | All randomized participants who received at least 1 dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants Receiving Concomitant Medication | Baseline to study endpoint (up to 37.06 months) | All randomized participants | participants | NUMBER |
| SECONDARY | Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G) | Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days) | The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT-G data, using the intent-to-treat principle. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group82
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Pem/Carbo/Bev | 12.55 | 95% Confidence Interval 11.30 to 14.03 | months | |
| Overall Survival | Pac/Carbo/Bev | 13.40 | 95% Confidence Interval 11.86 to 14.91 | months | |
| Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate) | Pem/Carbo/Bev | 34.1 | 95% Confidence Interval 29.8 to 38.6 | percentage of participants | |
| Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate) | Pac/Carbo/Bev | 33.0 | 95% Confidence Interval 28.7 to 37.4 | percentage of participants | |
| Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate) | Pem/Carbo/Bev | 65.9 | 95% Confidence Interval 61.4 to 70.2 | percentage of participants | |
| Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate) | Pac/Carbo/Bev | 69.8 | 95% Confidence Interval 65.4 to 73.9 | percentage of participants | |
| Progression Free Survival Time | Pem/Carbo/Bev | 6.04 | 95% Confidence Interval 5.55 to 6.87 | months | |
| Progression Free Survival Time | Pac/Carbo/Bev | 5.55 | 95% Confidence Interval 5.39 to 5.98 | months | |
| Time to Progressive Disease | Pem/Carbo/Bev | 7.03 | 95% Confidence Interval 6.24 to 8.05 | months | |
| Time to Progressive Disease | Pac/Carbo/Bev | 6.04 | 95% Confidence Interval 5.58 to 6.87 | months |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period | STARTED | Pem/Carbo/Bev | 472 | |
| Induction Period | STARTED | Pac/Carbo/Bev | 467 | |
| Induction Period | Received at Least 1 Dose of Study Drug | Pem/Carbo/Bev | 442 | |
| Induction Period | Received at Least 1 Dose of Study Drug | Pac/Carbo/Bev | 443 | |
| Induction Period | COMPLETED | Pem/Carbo/Bev | 294 | |
| Induction Period | COMPLETED | Pac/Carbo/Bev | 298 | |
| Induction Period | NOT COMPLETED | Pem/Carbo/Bev | 178 | |
| Induction Period | NOT COMPLETED | Pac/Carbo/Bev | 169 | |
| Maintenance Period | STARTED | Pem/Carbo/Bev | 294 | |
| Maintenance Period | STARTED | Pac/Carbo/Bev | 298 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events634
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 | Pem/Carbo/Bev | 177 | 442 | 1,367 |
| other | Anaemia | Blood and lymphatic system disorders | Pac/Carbo/Bev | 136 | 443 | 793 |
| other | Leukopenia | Blood and lymphatic system disorders | Pem/Carbo/Bev | 73 | 442 | 387 |
| other | Leukopenia | Blood and lymphatic system disorders | Pac/Carbo/Bev | 76 | 443 | 362 |
| other | Neutropenia | Blood and lymphatic system disorders | Pem/Carbo/Bev | 170 | 442 | 733 |
| other | Neutropenia | Blood and lymphatic system disorders | Pac/Carbo/Bev | 219 | 443 | 790 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pem/Carbo/Bev | 159 | 442 | 829 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pac/Carbo/Bev | 105 | 443 | 452 |
| other | Lacrimation increased | Eye disorders | Pem/Carbo/Bev | 31 | 442 | 405 |
| other | Lacrimation increased | Eye disorders | Pac/Carbo/Bev | 2 | 443 | 12 |
1 to 10 of 634Source ClinicalTrials.gov
See all 634 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pem/Carbo/Bev | ||
| Total, all-cause mortality | Pac/Carbo/Bev | ||
| Total, other adverse events | Pem/Carbo/Bev | 430 | 442 |
| Total, other adverse events | Pac/Carbo/Bev | 433 | 443 |
| Total, serious adverse events | Pem/Carbo/Bev | 188 | 442 |
| Total, serious adverse events | Pac/Carbo/Bev | 181 | 443 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pem/Carbo/Bev vs Pac/Carbo/Bev: Number of Participants Who Received a Transfusion | Trial comparisons |
| Pem/Carbo/Bev vs Pac/Carbo/Bev: Number of Participants Receiving Concomitant Medication | Trial comparisons |
| Pem/Carbo/Bev vs Pac/Carbo/Bev: serious adverse events | 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/NCT00762034
GET https://conductscience.org/api/trials/v1/NCT00762034/registered?page=2