Trial · NCT00842712
Cilengitide and Cetuximab in Combination With Platinum-based Chemotherapy as First-line Treatment for Subjects With Advanced Non Small Cell Lung Cancer (NSCLC)
NCT00842712, Phase 2, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2014-09-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cilengitide and Cetuximab in Combination With Platinum-based Chemotherapy as First-line Treatment for Subjects With Advanced Non Small Cell Lung Cancer (NSCLC). Trials, record NCT00842712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00842712
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cilengitide and Cetuximab in Combination With Platinum-based Chemotherapy as First-line Treatment for Subjects With Advanced Non Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT00842712
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 232 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Cilengitide, Cilengitide, Cetuximab, Cisplatin, Cisplatin, Gemcitabine, Vinorelbine, Cilengitide, Cilengitide, Cetuximab, Chemotherapy
- First posted
- 2009-02-12
- Last updated
- 2017-01-13
- Other registries' IDs
- eudract:2008-004148-35
- Results first posted
- 2014-09-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to Week 3 | |
| Primary | Randomized Part: Progression Free Survival (PFS) Time - Independent Read | Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013) | The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC). |
| Secondary | Randomized Part: Progression Free Survival (PFS) Time - Investigator Read | Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013) | The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site. |
| Secondary | Randomized Part: Overall Survival (OS) Time | Time from randomization until death or last day known to be alive, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013) | The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. |
| Secondary | Randomized Part: Best Overall Response (BOR) Rate | Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013) | The BOR rate is defined as the percentage of participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors \[RECIST\]) as assessed by Independent Review Committee (IRC): CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions. |
| Secondary | Randomized Part: Time to Treatment Failure | Time from randomization until treatment failure or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013) | Time to treatment failure was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: Progressive Disease (PD) assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment. Time to treatment failure was assessed according to modified World Health Organization (WHO) criteria by Independent Review Committee (IRC). |
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 | Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to Week 3 | DLT population included all participants who completed first 3 weeks of treatment (first chemotherapy cycle) or who discontinued treatment due to any DLT during the first 3 weeks of treatment in the safety-run-in part. | participants | NUMBER |
| PRIMARY | Randomized Part: Progression Free Survival (PFS) Time - Independent Read | Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013) | Intent-to-treat (ITT) population included all participants who were randomized to trial treatment. | months | MEDIAN |
| SECONDARY | Randomized Part: Progression Free Survival (PFS) Time - Investigator Read | Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013) | ITT population included all participants who were randomized to trial treatment. | months | MEDIAN |
| SECONDARY | Randomized Part: Overall Survival (OS) Time | Time from randomization until death or last day known to be alive, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013) | ITT population included all participants who were randomized to trial treatment. | months | MEDIAN |
| SECONDARY | Randomized Part: Best Overall Response (BOR) Rate | Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013) | ITT population included all participants who were randomized to trial treatment. | percentage of participants | NUMBER |
| SECONDARY | Randomized Part: Time to Treatment Failure | Time from randomization until treatment failure or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013) | ITT population included all participants who were randomized to trial treatment. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs) | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem | 0 | participants | ||
| Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs) | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin | 0 | participants | ||
| Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs) | Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem | 0 | participants | ||
| Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs) | Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin | 0 | participants | ||
| Randomized Part: Progression Free Survival (PFS) Time - Independent Read | Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy | 6.2 | 95% Confidence Interval 5.6 to 7.4 | months | |
| Randomized Part: Progression Free Survival (PFS) Time - Independent Read | Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy | 5.6 | 95% Confidence Interval 4.0 to 7.5 | months | |
| Randomized Part: Progression Free Survival (PFS) Time - Independent Read | Randomized Part: Cetuximab + Chemotherapy | 5.0 | 95% Confidence Interval 4.2 to 5.6 | months | |
| Randomized Part: Progression Free Survival (PFS) Time - Investigator Read | Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy | 5.6 | 95% Confidence Interval 5.4 to 6.7 | months | |
| Randomized Part: Progression Free Survival (PFS) Time - Investigator Read | Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy | 5.6 | 95% Confidence Interval 4.2 to 7.0 | months | |
| Randomized Part: Progression Free Survival (PFS) Time - Investigator Read | Randomized Part: Cetuximab + Chemotherapy | 5.3 | 95% Confidence Interval 4.2 to 5.7 | months |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow49
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Safety Run-in Part | STARTED | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem | 3 | |
| Safety Run-in Part | STARTED | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin | 3 | |
| Safety Run-in Part | STARTED | Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem | 3 | |
| Safety Run-in Part | STARTED | Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin | 3 | |
| Safety Run-in Part | STARTED | Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy | 0 | |
| Safety Run-in Part | STARTED | Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy | 0 | |
| Safety Run-in Part | STARTED | Randomized Part: Cetuximab + Chemotherapy | 0 | |
| Safety Run-in Part | COMPLETED | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem | 0 | |
| Safety Run-in Part | COMPLETED | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin | 1 | |
| Safety Run-in Part | COMPLETED | Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem | 3 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 participant flowAdverse events1,631
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 | RASH | Skin and subcutaneous tissue disorders | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem | 3 | 3 | |
| other | RASH | Skin and subcutaneous tissue disorders | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin | 3 | 3 | |
| other | RASH | Skin and subcutaneous tissue disorders | Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem | 3 | 3 | |
| other | RASH | Skin and subcutaneous tissue disorders | Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin | 3 | 3 | |
| other | RASH | Skin and subcutaneous tissue disorders | Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy | 35 | 85 | |
| other | RASH | Skin and subcutaneous tissue disorders | Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy | 17 | 50 | |
| other | RASH | Skin and subcutaneous tissue disorders | Randomized Part: Cetuximab + Chemotherapy | 29 | 80 | |
| other | ACNE | Skin and subcutaneous tissue disorders | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem | 0 | 3 | |
| other | ACNE | Skin and subcutaneous tissue disorders | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin | 0 | 3 | |
| other | ACNE | Skin and subcutaneous tissue disorders | Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem | 0 | 3 |
1 to 10 of 1,631Source ClinicalTrials.gov
See all 1,631 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem | ||
| Total, all-cause mortality | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin | ||
| Total, all-cause mortality | Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem | ||
| Total, all-cause mortality | Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin | ||
| Total, all-cause mortality | Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy | ||
| Total, all-cause mortality | Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy | ||
| Total, all-cause mortality | Randomized Part: Cetuximab + Chemotherapy | ||
| Total, other adverse events | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem | 3 | 3 |
| Total, other adverse events | Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin | 3 | 3 |
| Total, other adverse events | Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem | 3 | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25939894 | DERIVED |
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 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/NCT00842712
GET https://conductscience.org/api/trials/v1/NCT00842712/flow?page=2