Trial · NCT00300885

A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)

NCT00300885, Phase 3, Terminated, Bayer; results first posted 2010-09-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC). Trials, record NCT00300885. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00300885

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)
NCT number: NCT00300885
Status: Terminated
Phases: Phase 3
Enrollment: 926 participants, actual
Lead sponsor: Bayer
Conditions: Carcinoma, Non-Small Cell Lung
Interventions: Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel, Carboplatin plus Paclitaxel
First posted: 2006-03-10
Last updated: 2014-11-04
Other registries' IDs: eudract:2005-005245-19
Results first posted: 2010-09-20
Limitations and caveats: Based on the results of the interim analysis, it was determined that the study would not meet its primary efficacy endpoint and the study was terminated early. The planned biomarker analysis was suspended due to early termination.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo	Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis	Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks during study treatment and every 3 months during post-treatment.
Secondary	Progression Free Survival (PFS)	Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis	PFS determined as time (days) from the date of randomization at start of study to disease progression (radiological or clinical) or death due to any cause, if death occurs before progression.
Secondary	Overall Best Response	Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis	Best overall tumor response for the ITT population was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased).
Secondary	Duration of Response	Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis	Duration of response (PR or better) is defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented).
Secondary	Patient Reported Outcome as Assessed by FACT-L Score. Change From Baseline in Total FACT-L at Cycles 3,5,7,9 and End of Treatment (EOT)	Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every other cycle (i.e. Cycle 3, 5, 7 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis	Functional Assessment of Cancer Therapy - Lung cancer subscore (FACT-L). Patient reported outcome as assessed by FACT-L score. FACT-L questionnaire comprises statements about physical, social / family, emotional and functional well-being as well as additional concerns which have to be rated by the patients (0="not at all" to 4="very much"). Cycle duration defined as 21 days. Change from baseline in Total FACT-L on day 1 of cycles 3,5,7,9 (weeks 7,13,19 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation.
Secondary	Patient Reported Outcome as Assessed by LCS Subscale Score. Change From Baseline in LCS Subscale at Cycles 2 Through 9 and at End of Treatment (EOT)	Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every cycle (i.e. Cycle 2, 3, 4, 5 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis	Lung Cancer Symptoms (LCS) subscale ranges from 0 (severe debilitation) to 28 (asymptomatic). Cycle duration defined as 21 days. Change from baseline in LCS Subscale on day 1 of cycles 2 through 9 (weeks 4,7,10,13,16,19,22 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation.

Source ClinicalTrials.gov

Outcomes6

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 Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo	Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis	Evaluations of OS based on the ITT population. Subjects 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, if the day is missing, day 15 (the middle of the month) will be used.	days	MEDIAN
SECONDARY	Progression Free Survival (PFS)	Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis	PFS (based on the ITT population) for subjects without disease progression/death at the time of analysis were censored at the last evaluation date. PFS for surviving subjects without post-baseline tumor assessments were censored at one day. In the case of an incomplete date (missing day), day 15 (the middle of the month) will be used.	days	MEDIAN
SECONDARY	Overall Best Response	Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis	Evaluations of overall best response rate based on the ITT population.	percentage of participants	NUMBER
SECONDARY	Duration of Response	Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis	Evaluations of duration of response based on the ITT population.	days	MEDIAN
SECONDARY	Patient Reported Outcome as Assessed by FACT-L Score. Change From Baseline in Total FACT-L at Cycles 3,5,7,9 and End of Treatment (EOT)	Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every other cycle (i.e. Cycle 3, 5, 7 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis	Evaluations of Total FACT-L based on the ITT population.	Scores on a scale	MEAN
SECONDARY	Patient Reported Outcome as Assessed by LCS Subscale Score. Change From Baseline in LCS Subscale at Cycles 2 Through 9 and at End of Treatment (EOT)	Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every cycle (i.e. Cycle 2, 3, 4, 5 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis	Evaluations of LCS Subscale based on the ITT population.	Scores on a scale	MEAN

Source ClinicalTrials.gov

Results by group46

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 Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo	Sorafenib + C/P		324	95% Confidence Interval 277 to 423	days
Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo	Placebo + C/P		322	95% Confidence Interval 293 to 366	days
Progression Free Survival (PFS)	Sorafenib + C/P		139	95% Confidence Interval 132 to 160	days
Progression Free Survival (PFS)	Placebo + C/P		163	95% Confidence Interval 134 to 175	days
Overall Best Response	Sorafenib + C/P	Complete Response (CR)	0.0		percentage of participants
Overall Best Response	Placebo + C/P	Complete Response (CR)	1.1		percentage of participants
Overall Best Response	Sorafenib + C/P	Partial Response (PR)	27.4		percentage of participants
Overall Best Response	Placebo + C/P	Partial Response (PR)	22.9		percentage of participants
Overall Best Response	Sorafenib + C/P	Stable Disease (SD)	45.9		percentage of participants
Overall Best Response	Placebo + C/P	Stable Disease (SD)	47.8		percentage of participants

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment	STARTED	Sorafenib + C/P	464
Treatment	STARTED	Placebo + C/P	462
Treatment	Received Treatment	Sorafenib + C/P	463
Treatment	Received Treatment	Placebo + C/P	459
Treatment	COMPLETED	Sorafenib + C/P	91
Treatment	COMPLETED	Placebo + C/P	88
Treatment	NOT COMPLETED	Sorafenib + C/P	373
Treatment	NOT COMPLETED	Placebo + C/P	374
Follow-up	STARTED	Sorafenib + C/P	354
Follow-up	STARTED	Placebo + C/P	369

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events442

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
other	Neutrophils	Blood and lymphatic system disorders	Sorafenib + C/P	170	463
other	Neutrophils	Blood and lymphatic system disorders	Placebo + C/P	168	459
other	Hemoglobin	Blood and lymphatic system disorders	Sorafenib + C/P	145	463
other	Hemoglobin	Blood and lymphatic system disorders	Placebo + C/P	148	459
other	Platelets	Blood and lymphatic system disorders	Sorafenib + C/P	140	463
other	Platelets	Blood and lymphatic system disorders	Placebo + C/P	67	459
other	Leukocytes	Blood and lymphatic system disorders	Sorafenib + C/P	78	463
other	Leukocytes	Blood and lymphatic system disorders	Placebo + C/P	67	459
other	Hypertension	Cardiac disorders	Sorafenib + C/P	90	463
other	Hypertension	Cardiac disorders	Placebo + C/P	46	459

1 to 10 of 442Source ClinicalTrials.gov

See all 442 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sorafenib + C/P
Total, all-cause mortality	Placebo + C/P
Total, other adverse events	Sorafenib + C/P	454	463
Total, other adverse events	Placebo + C/P	450	459
Total, serious adverse events	Sorafenib + C/P	272	463
Total, serious adverse events	Placebo + C/P	195	459

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20212250	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 + C/P vs Placebo + C/P: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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