Trial · NCT00409188
Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)
NCT00409188, Phase 3, Completed, EMD Serono; results first posted 2015-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START). Trials, record NCT00409188. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00409188
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)
- NCT number
- NCT00409188
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,513 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Tecemotide (L-BLP25), Single low dose cyclophosphamide, Placebo
- First posted
- 2006-12-08
- Last updated
- 2015-11-20
- Results first posted
- 2015-11-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Up to 66 months | Overall survival time was defined as the time from randomization to death. Participants without events were censored at the last date they were known to be alive or the clinical cut-off date, whatever was earlier. |
| Secondary | Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS) | Up to 66 months | Time to symptom progression (TTSP) was measured by LCSS. Symptomatic progression was defined as an increase (worsening) of the Average Symptomatic Burden Index (ASBI that is, the mean of the six major lung cancer specific symptom scores of the LCSS patient scale - ranging from 0 to 100 where higher score indicates worst outcome). Worsening was defined as a 10% increase in the scale breadth from the baseline score. TTSP is defined as the time from randomization to worsening in ASBI. Participants without event are censored at the date of the last LCSS assessment. |
| Secondary | Time To Progression (TTP) | Up to 66 months | Time from randomization to disease progression. Disease progression was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 \[RECIST v1.0\]) as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions. |
| Secondary | One-, Two- and Three-year Survival Rate | Years 1, 2, and 3 | The percentages of participants who were alive at 1, 2, and 3 years were calculated as a cumulative percentage by Kaplan-Meier survival analysis approach. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions | From first dose up to 42 days after the last dose of the trial treatment | Treatment -emergent adverse events were defined as those with onset or worsening occurring at or after the first dosing day of study medication and up to 42 days after the last administration of any study drug or the clinical cut-off date. Injection site reactions were reported as assessed by the Investigator. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Up to 66 months | Primary analysis set (modified intention-to-treat \[ITT\] population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold. | months | MEDIAN |
| SECONDARY | Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS) | Up to 66 months | Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold. N signifies the number of participants who were evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Time To Progression (TTP) | Up to 66 months | Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold. | months | MEDIAN |
| SECONDARY | One-, Two- and Three-year Survival Rate | Years 1, 2, and 3 | Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions | From first dose up to 42 days after the last dose of the trial treatment | Safety analysis set included all participants who received at least 1 dose of trial treatment (cyclophosphamide, tecemotide, saline, or placebo). Participants were reported based on the actual treatment received (as-treated). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Tecemotide (L-BLP25) + Cyclophosphamide | 25.6 | 95% Confidence Interval 22.5 to 29.2 | months | |
| Overall Survival | Saline + Placebo | 22.3 | 95% Confidence Interval 19.6 to 25.5 | months | |
| Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS) | Tecemotide (L-BLP25) + Cyclophosphamide | 14.2 | 95% Confidence Interval 12.9 to 15.7 | months | |
| Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS) | Saline + Placebo | 11.4 | 95% Confidence Interval 9.3 to 13.1 | months | |
| Time To Progression (TTP) | Tecemotide (L-BLP25) + Cyclophosphamide | 10.0 | 95% Confidence Interval 9.1 to 11.5 | months | |
| Time To Progression (TTP) | Saline + Placebo | 8.4 | 95% Confidence Interval 7.2 to 10.8 | months | |
| One-, Two- and Three-year Survival Rate | Tecemotide (L-BLP25) + Cyclophosphamide | Year 1 | 77.0 | percentage of participants | |
| One-, Two- and Three-year Survival Rate | Saline + Placebo | Year 1 | 74.7 | percentage of participants | |
| One-, Two- and Three-year Survival Rate | Tecemotide (L-BLP25) + Cyclophosphamide | Year 2 | 50.8 | percentage of participants | |
| One-, Two- and Three-year Survival Rate | Saline + Placebo | Year 2 | 45.9 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tecemotide (L-BLP25) + Cyclophosphamide | 1,006 | |
| Overall Study | STARTED | Saline + Placebo | 507 | |
| Overall Study | COMPLETED | Tecemotide (L-BLP25) + Cyclophosphamide | 623 | |
| Overall Study | COMPLETED | Saline + Placebo | 332 | |
| Overall Study | NOT COMPLETED | Tecemotide (L-BLP25) + Cyclophosphamide | 383 | |
| Overall Study | NOT COMPLETED | Saline + Placebo | 175 |
Source ClinicalTrials.gov
Adverse events574
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 | Constipation | Gastrointestinal disorders | Tecemotide (L-BLP25) + Cyclophosphamide | 75 | 1,024 | |
| other | Constipation | Gastrointestinal disorders | Saline + Placebo | 26 | 477 | |
| other | Diarrhoea | Gastrointestinal disorders | Tecemotide (L-BLP25) + Cyclophosphamide | 85 | 1,024 | |
| other | Diarrhoea | Gastrointestinal disorders | Saline + Placebo | 46 | 477 | |
| other | Nausea | Gastrointestinal disorders | Tecemotide (L-BLP25) + Cyclophosphamide | 140 | 1,024 | |
| other | Nausea | Gastrointestinal disorders | Saline + Placebo | 39 | 477 | |
| other | Vomiting | Gastrointestinal disorders | Tecemotide (L-BLP25) + Cyclophosphamide | 65 | 1,024 | |
| other | Vomiting | Gastrointestinal disorders | Saline + Placebo | 26 | 477 | |
| other | Asthenia | General disorders | Tecemotide (L-BLP25) + Cyclophosphamide | 71 | 1,024 | |
| other | Asthenia | General disorders | Saline + Placebo | 29 | 477 |
1 to 10 of 574Source ClinicalTrials.gov
See all 574 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tecemotide (L-BLP25) + Cyclophosphamide | ||
| Total, all-cause mortality | Saline + Placebo | ||
| Total, other adverse events | Tecemotide (L-BLP25) + Cyclophosphamide | 918 | 1,024 |
| Total, other adverse events | Saline + Placebo | 417 | 477 |
| Total, serious adverse events | Tecemotide (L-BLP25) + Cyclophosphamide | 303 | 1,024 |
| Total, serious adverse events | Saline + Placebo | 151 | 477 |
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 |
|---|
| Tecemotide (L-BLP25) + Cyclophosphamide vs Saline + Placebo: 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/NCT00409188
GET https://conductscience.org/api/trials/v1/NCT00409188/events?page=2