Trial · NCT00981058
First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
NCT00981058, Phase 3, Completed, Eli Lilly and Company; results first posted 2016-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin. Trials, record NCT00981058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00981058
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
- NCT number
- NCT00981058
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,093 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Necitumumab, Gemcitabine, Cisplatin
- First posted
- 2009-09-22
- Last updated
- 2025-06-18
- Other registries' IDs
- eudract:2009-013838-25
- Results first posted
- 2016-06-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival Time (OS) | Randomization to Death from Any Cause (Up to 31 Months) | Overall survival is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated by the Kaplan-Meier method. |
| Secondary | Progression-Free Survival (PFS) | Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months) | PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participants were censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits. |
| Secondary | Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR]) | Baseline to Measured Progressive Disease (Up to 31 Months) | ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions. PR defined as a \>=30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \* 100. |
| Secondary | Time to Treatment Failure (TTF) | Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months) | TTF is defined as the time from the date of randomization until the date of the first radiographic documentation of PD, death from any cause, discontinuation of treatment for any reason, or initiation of new cancer therapy. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study. |
| Secondary | Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D) | Baseline, Cycle 6 (Cycle = 3 Weeks) | The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). |
| Secondary | Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS) | Baseline, Cycle 6 (Cycle = 3 Weeks) | The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. |
| Secondary | Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC) | 31 Months | EGFR IHC Histoscore H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria was used to assess participants with a low EGFR expression defined by a H-score cutoff value of \<200 and participants with a high EGFR expression defined by a H-score of cutoff value of \>=200. |
| Secondary | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab | Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months | |
| Secondary | Number of Participants With a Serum Anti-Necitumumab Antibody Assessment | Baseline through 31 Months | A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival Time (OS) | Randomization to Death from Any Cause (Up to 31 Months) | All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 127, Gemcitabine + Cisplatin = 106 | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months) | All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 114, Gemcitabine + Cisplatin = 131 | months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR]) | Baseline to Measured Progressive Disease (Up to 31 Months) | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Time to Treatment Failure (TTF) | Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months) | All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 16, Gemcitabine + Cisplatin =20 | Months | MEDIAN |
| SECONDARY | Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D) | Baseline, Cycle 6 (Cycle = 3 Weeks) | All randomized participants who had evaluable baseline and postbaseline EQ-5D data. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS) | Baseline, Cycle 6 (Cycle = 3 Weeks) | All randomized participants who had evaluable data for LCSS. | millimeter (mm) | MEAN |
| SECONDARY | Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC) | 31 Months | All randomized participants who received at least one dose of study drug and had evaluable data for EGFR IHC. | participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab | Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months | All randomized participants who received at least one dose of study drug and had evaluable data for PK. | micrograms/milliliter (ug/mL) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With a Serum Anti-Necitumumab Antibody Assessment | Baseline through 31 Months | All randomized participants who received who received at least 1 dose of drug and had evaluable data for antibodies. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival Time (OS) | Necitumumab + Gemcitabine + Cisplatin | 11.5 | 95% Confidence Interval 10.4 to 12.6 | Months | |
| Overall Survival Time (OS) | Gemcitabine + Cisplatin | 9.9 | 95% Confidence Interval 8.9 to 11.1 | Months | |
| Progression-Free Survival (PFS) | Necitumumab + Gemcitabine + Cisplatin | 5.7 | 95% Confidence Interval 5.6 to 6.0 | months | |
| Progression-Free Survival (PFS) | Gemcitabine + Cisplatin | 5.5 | 95% Confidence Interval 4.8 to 5.6 | months | |
| Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR]) | Necitumumab + Gemcitabine + Cisplatin | 31.2 | 95% Confidence Interval 27.4 to 35.2 | percentage of participants | |
| Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR]) | Gemcitabine + Cisplatin | 28.8 | 95% Confidence Interval 25.2 to 32.8 | percentage of participants | |
| Time to Treatment Failure (TTF) | Necitumumab + Gemcitabine + Cisplatin | 4.3 | 95% Confidence Interval 4.2 to 4.8 | Months | |
| Time to Treatment Failure (TTF) | Gemcitabine + Cisplatin | 3.6 | 95% Confidence Interval 3.3 to 4.1 | Months | |
| Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D) | Necitumumab + Gemcitabine + Cisplatin | -0.0053 | Standard Deviation 0.23626 | units on a scale | |
| Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D) | Gemcitabine + Cisplatin | -0.0083 | Standard Deviation 0.23866 | units on a scale |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Necitumumab + Gemcitabine + Cisplatin | 545 | |
| Overall Study | STARTED | Gemcitabine + Cisplatin | 548 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Necitumumab + Gemcitabine + Cisplatin | 538 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Gemcitabine + Cisplatin | 541 | |
| Overall Study | COMPLETED | Necitumumab + Gemcitabine + Cisplatin | 476 | |
| Overall Study | COMPLETED | Gemcitabine + Cisplatin | 487 | |
| Overall Study | NOT COMPLETED | Necitumumab + Gemcitabine + Cisplatin | 69 | |
| Overall Study | NOT COMPLETED | Gemcitabine + Cisplatin | 61 |
Source ClinicalTrials.gov
Adverse events532
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 | Necitumumab + Gemcitabine + Cisplatin | 221 | 538 | 221 |
| other | Anaemia | Blood and lymphatic system disorders | Gemcitabine + Cisplatin | 246 | 541 | 246 |
| other | Leukopenia | Blood and lymphatic system disorders | Necitumumab + Gemcitabine + Cisplatin | 71 | 538 | 71 |
| other | Leukopenia | Blood and lymphatic system disorders | Gemcitabine + Cisplatin | 85 | 541 | 85 |
| other | Neutropenia | Blood and lymphatic system disorders | Necitumumab + Gemcitabine + Cisplatin | 220 | 538 | 220 |
| other | Neutropenia | Blood and lymphatic system disorders | Gemcitabine + Cisplatin | 229 | 541 | 229 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Necitumumab + Gemcitabine + Cisplatin | 103 | 538 | 103 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Gemcitabine + Cisplatin | 124 | 541 | 124 |
| other | Abdominal pain upper | Gastrointestinal disorders | Necitumumab + Gemcitabine + Cisplatin | 31 | 538 | 31 |
| other | Abdominal pain upper | Gastrointestinal disorders | Gemcitabine + Cisplatin | 29 | 541 | 29 |
1 to 10 of 532Source ClinicalTrials.gov
See all 532 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Necitumumab + Gemcitabine + Cisplatin | 476 | 538 |
| Total, all-cause mortality | Gemcitabine + Cisplatin | 487 | 541 |
| Total, other adverse events | Necitumumab + Gemcitabine + Cisplatin | 518 | 538 |
| Total, other adverse events | Gemcitabine + Cisplatin | 512 | 541 |
| Total, serious adverse events | Necitumumab + Gemcitabine + Cisplatin | 262 | 538 |
| Total, serious adverse events | Gemcitabine + Cisplatin | 208 | 541 |
Source ClinicalTrials.gov
Papers5
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Necitumumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin: deaths from any cause | Trial comparisons |
| Necitumumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin: 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/NCT00981058
GET https://conductscience.org/api/trials/v1/NCT00981058/results?page=2