Trial · NCT00449033
A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)
NCT00449033, Phase 3, Completed, Bayer; results first posted 2011-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC). Trials, record NCT00449033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00449033
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT00449033
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 904 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Sorafenib (Nexavar, BAY43-9006), Placebo, Gemcitabine, Cisplatin
- First posted
- 2007-03-19
- Last updated
- 2015-04-23
- Other registries' IDs
- eudract:2006-002688-26
- Results first posted
- 2011-09-09
- Limitations and caveats
Inclusion of squamous patients stopped in FEB 2008, as 11961 (NCT00558636) trial reported higher mortality for this subgroup. Squamous patients in 12006 (NCT00449033) trial discontinued drug as a precaution endorsed by Data Monitoring Committee.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death of any cause whichever came first | Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact. |
| Secondary | OS in the ITT (Both Squamous and Non-squamous) Population | from randomization of the first patient until 38 months or date of death of any cause whichever came first | OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact. |
| Secondary | OS in the ITT (Squamous) Population | from randomization of the first patient until 38 months or date of death of any cause whichever came first | OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact. |
| Secondary | Progression-free Survival (PFS) in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks | PFS was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0) or death due to any cause, whichever occured first. Patients without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions. |
| Secondary | Time to Progression (TTP) in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks | TTP was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using RECIST version 1.0). Patients without progression at the time of analysis or death before progression were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions. |
| Secondary | Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks | Tumor response (= Best Overall Response) of a patient was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes or new lesions)) observed during trial period assessed according to the RECIST criteria (version 1.0) based on Investigator-assessment. |
| Secondary | Disease Control (DC) in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks | DC was defined as the total number of patients whose best response was not PD according to RECIST (version 1.0) by Investigator-assessment (= total number of CR + total number of PR + total number of SD; CR or PR had to be maintained for at least 28 days from the first demonstration of that rating, SD had to be documented at least once more than 6 weeks from baseline). PD: an increase in the sum of tumor lesions sizes or new lesions. |
| Secondary | Duration of Response in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks | Duration of response was defined as the time from date of first documented objective response of PR or CR, whichever was noted earlier, to date of disease progression or death (if death occurred before progression was documented). Patients without disease progression at the time of analysis or death before progression were censored at the last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions. |
| Secondary | Duration of Stable Disease (SD) in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks | Duration of SD was defined as the time from date of randomization to date that disease progression (radiological or clinical, whichever was earlier) was first documented. Patients without disease progression at the time of analysis or death before progression were censored at the date of their last tumor assessment.(Disease progression: increase in the sum of tumor lesion sizes or new lesions.) Duration of stable disease was only evaluated in patients failing to achieve a best response of CR or PR. |
| Secondary | Time to Response (TTR) in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death of any cause whichever came first | TTR for patients who achieved a best response (CR or PR) was defined as the time from date of randomization to the earliest date that response was first documented. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death of any cause whichever came first | Evaluation of OS based on ITT (non-squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used. | days | MEDIAN |
| SECONDARY | OS in the ITT (Both Squamous and Non-squamous) Population | from randomization of the first patient until 38 months or date of death of any cause whichever came first | Evaluation of OS based on ITT (both non-squamous and squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used. | days | MEDIAN |
| SECONDARY | OS in the ITT (Squamous) Population | from randomization of the first patient until 38 months or date of death of any cause whichever came first | Evaluation of OS based on ITT (squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used. No statistical testing performed. | days | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks | Evaluation of PFS based on ITT (non-squamous) population. PFS for patients with no tumour assessments after baseline was censored at one day. | days | MEDIAN |
| SECONDARY | Time to Progression (TTP) in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks | Evaluation of TTP based on ITT (non-squamous) population. TTP for patients with no tumour assessments after baseline was censored at one day. | days | MEDIAN |
| SECONDARY | Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks | Evaluation of Tumour Response based on ITT (non-squamous) population. | percentage of participants | NUMBER |
| SECONDARY | Disease Control (DC) in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks | Evaluation of Disease Control based on ITT (non-squamous) population. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks | Evaluation of duration of response based on ITT (non-squamous) population. No statistical testing performed. | days | MEDIAN |
| SECONDARY | Duration of Stable Disease (SD) in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks | Evaluation of duration of stable disease based on ITT (non-squamous) population. No statistical testing performed. | days | MEDIAN |
| SECONDARY | Time to Response (TTR) in the ITT (Non-squamous) Population | from randomization of the first patient until 38 months or date of death of any cause whichever came first | Evaluation of TTR based on ITT (non-squamous) population. No statistical testing performed. | days | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) in the ITT (Non-squamous) Population | Sorafenib (Nexavar, BAY43-9006) + GC | 376 | 95% Confidence Interval 333 to 416 | days | |
| Overall Survival (OS) in the ITT (Non-squamous) Population | Placebo + GC | 379 | 95% Confidence Interval 335 to 414 | days | |
| OS in the ITT (Both Squamous and Non-squamous) Population | Sorafenib (Nexavar, BAY43-9006) + GC | 371 | 95% Confidence Interval 322 to 410 | days | |
| OS in the ITT (Both Squamous and Non-squamous) Population | Placebo + GC | 378 | 95% Confidence Interval 335 to 412 | days | |
| OS in the ITT (Squamous) Population | Sorafenib (Nexavar, BAY43-9006) + GC | 254 | 95% Confidence Interval 197 to 455 | days | |
| OS in the ITT (Squamous) Population | Placebo + GC | 374 | 95% Confidence Interval 282 to 519 | days | |
| Progression-free Survival (PFS) in the ITT (Non-squamous) Population | Sorafenib (Nexavar, BAY43-9006) + GC | 183 | 95% Confidence Interval 168 to 208 | days | |
| Progression-free Survival (PFS) in the ITT (Non-squamous) Population | Placebo + GC | 168 | 95% Confidence Interval 156 to 174 | days | |
| Time to Progression (TTP) in the ITT (Non-squamous) Population | Sorafenib (Nexavar, BAY43-9006) + GC | 185 | 95% Confidence Interval 171 to 210 | days | |
| Time to Progression (TTP) in the ITT (Non-squamous) Population | Placebo + GC | 167 | 95% Confidence Interval 156 to 173 | days |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Sorafenib (Nexavar, BAY43-9006) + GC | 452 | |
| Treatment Period | STARTED | Placebo + GC | 452 | |
| Treatment Period | Received Treatment | Sorafenib (Nexavar, BAY43-9006) + GC | 452 | |
| Treatment Period | Received Treatment | Placebo + GC | 449 | |
| Treatment Period | COMPLETED | Sorafenib (Nexavar, BAY43-9006) + GC | 0 | |
| Treatment Period | COMPLETED | Placebo + GC | 0 | |
| Treatment Period | NOT COMPLETED | Sorafenib (Nexavar, BAY43-9006) + GC | 452 | |
| Treatment Period | NOT COMPLETED | Placebo + GC | 452 | |
| Follow-up Period | STARTED | Sorafenib (Nexavar, BAY43-9006) + GC | 425 | |
| Follow-up Period | STARTED | Placebo + GC | 434 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events450
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 | Blood - Other | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + GC | 16 | 452 | |
| other | Blood - Other | Blood and lymphatic system disorders | Placebo + GC | 34 | 449 | |
| other | Edema: Limb | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + GC | 22 | 452 | |
| other | Edema: Limb | Blood and lymphatic system disorders | Placebo + GC | 39 | 449 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + GC | 214 | 452 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Placebo + GC | 221 | 449 | |
| other | Leukocytes | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + GC | 158 | 452 | |
| other | Leukocytes | Blood and lymphatic system disorders | Placebo + GC | 146 | 449 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) + GC | 30 | 452 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo + GC | 17 | 449 |
1 to 10 of 450Source ClinicalTrials.gov
See all 450 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sorafenib (Nexavar, BAY43-9006) + GC | ||
| Total, all-cause mortality | Placebo + GC | ||
| Total, other adverse events | Sorafenib (Nexavar, BAY43-9006) + GC | 440 | 452 |
| Total, other adverse events | Placebo + GC | 435 | 449 |
| Total, serious adverse events | Sorafenib (Nexavar, BAY43-9006) + GC | 270 | 452 |
| Total, serious adverse events | Placebo + GC | 198 | 449 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22851564 | RESULT |
Source PubMed
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 |
|---|
| Sorafenib (Nexavar, BAY43-9006) + GC vs Placebo + GC: 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/NCT00449033
GET https://conductscience.org/api/trials/v1/NCT00449033/results?page=2