Trial · NCT01218516
A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
NCT01218516, Phase 2, Completed, Morphotek; results first posted 2020-08-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung. Trials, record NCT01218516. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01218516
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
- NCT number
- NCT01218516
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 130 participants, actual
- Lead sponsor
- Morphotek
- Conditions
- Adenocarcinoma of the Lung
- Interventions
- Farletuzumab, Placebo, Carboplatin, Paclitaxel, Pemetrexed, Cisplatin
- First posted
- 2010-10-11
- Last updated
- 2020-08-20
- Other registries' IDs
- eudract:2010-022229-13
- Results first posted
- 2020-08-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | From date of first administration of study drug up to 6 month follow-up from randomization of the last participant, i.e., cut-off date 15 Dec 2012 for primary analysis and cut-off date of 1 Nov 2013 or up to approximately 28 months for final analysis | PFS was defined as the time from the date of randomization to the date of the first observation of investigator-assessed (radiology review) progression based on Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1 or other protocol-approved measures of disease progression (e.g., new occurrence of positive fluid cytology, newly diagnosed evidence of disease progression from histologic samples, PET-positive metastases, or new bone or brain metastases), or date of death, whatever the cause. Disease progression as assessed by the investigator per RECIST v1.0 was defined as at least a 20% increase in sum of longest diameters (RECIST definition) compared to baseline (or lowest sum while on study if less than baseline), or any new lesions (measurable or nonmeasurable). |
| Secondary | Overall Response Rate (ORR) | From Day 1 until documented radiographic progression, other protocol-approved measures of disease progression, withdrawal by participant, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis | ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator's radiologic assessments using RECIST 1.1 for target lesions and assessed by Magnetic resonance imaging (MRI) and computerized tomography (CT) scan (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR. |
| Secondary | Duration of Response (DR) | From the first documentation of objective response (CR or PR) to the first documentation of disease progression, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis | DR was derived for those participants with objective evidence of CR or PR. DR was defined as the time (in months) from first documentation of objective response (CR or PR) to the first documentation of disease progression (ie, objective tumor progression as assessed by investigator's radiology review or other protocol-approved measures of disease progression) or death due to any cause. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Overall Survival (OS) | From the date of randomization to the date of death due to any cause or up to cut-off date of 1 Nov 2013 (up to approximately 28 months) for final analysis | OS was defined as the time (in months) from the date of randomization to the date of death, regardless of cause. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) | For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis | An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the participant was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, TEAEs (defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed. |
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 | Progression-free Survival (PFS) | From date of first administration of study drug up to 6 month follow-up from randomization of the last participant, i.e., cut-off date 15 Dec 2012 for primary analysis and cut-off date of 1 Nov 2013 or up to approximately 28 months for final analysis | The ITT population included all randomized participants who received at least 1 dose of test article (placebo or farletuzumab), with treatment assignments designated according to actual study treatment received. This was the primary analysis population for evaluating treatment administration, tolerability, and safety. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | From Day 1 until documented radiographic progression, other protocol-approved measures of disease progression, withdrawal by participant, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis | The ITT population included all randomized participants who received at least 1 dose of test article (placebo or farletuzumab), with treatment assignments designated according to actual study treatment received. This was the primary analysis population for evaluating treatment administration, tolerability, and safety. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DR) | From the first documentation of objective response (CR or PR) to the first documentation of disease progression, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis | Tumor Response (TR) Evaluable Analysis Set (responders only) included all participants who received at least 1 dose of test article and who had a baseline assessment and at least 1 on-treatment assessment performed, sufficient to assess the endpoint of interest. The TR Evaluable Analysis Set was used for all RECIST assessments of tumor response. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the date of randomization to the date of death due to any cause or up to cut-off date of 1 Nov 2013 (up to approximately 28 months) for final analysis | The ITT population included all randomized participants who received at least 1 dose of test article (placebo or farletuzumab), with treatment assignments designated according to actual study treatment received. This was the primary analysis population for evaluating treatment administration, tolerability, and safety. | Months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) | For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis | The safety analysis set (SAS) included randomized participants who received at least 1 dose of test article, with treatment assignments designated according to actual study treatment received. This was the primary analysis population for evaluating treatment administration, tolerability, and safety. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Combination Therapy: Placebo + Chemotherapy | Per Primary Analysis Cut-Off Date | 5.8 | 95% Confidence Interval 5.0 to 6.8 | Months |
| Progression-free Survival (PFS) | Combination Therapy: Farletuzumab + Chemotherapy | Per Primary Analysis Cut-Off Date | 4.7 | 95% Confidence Interval 4.2 to 5.6 | Months |
| Progression-free Survival (PFS) | Combination Therapy: Placebo + Chemotherapy | Per Final Analysis Cut-Off Date | 5.9 | 95% Confidence Interval 5.0 to 7.0 | Months |
| Progression-free Survival (PFS) | Combination Therapy: Farletuzumab + Chemotherapy | Per Final Analysis Cut-Off Date | 4.7 | 95% Confidence Interval 4.2 to 5.6 | Months |
| Overall Response Rate (ORR) | Combination Therapy: Placebo + Chemotherapy | 37.3 | Percentage of participants | ||
| Overall Response Rate (ORR) | Combination Therapy: Farletuzumab + Chemotherapy | 41.3 | Percentage of participants | ||
| Duration of Response (DR) | Combination Therapy: Placebo + Chemotherapy | 6.7 | 95% Confidence Interval 4.1 to 9.4 | Months | |
| Duration of Response (DR) | Combination Therapy: Farletuzumab + Chemotherapy | 4.1 | 95% Confidence Interval 3.0 to 7.0 | Months | |
| Overall Survival (OS) | Combination Therapy: Placebo + Chemotherapy | 10.5 | 95% Confidence Interval 8.3 to 14.0 | Months | |
| Overall Survival (OS) | Combination Therapy: Farletuzumab + Chemotherapy | 14.1 | 95% Confidence Interval 9.5 to 18.6 | Months |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Combination Therapy (up to 4.5 Months) | STARTED | Combination Therapy: Placebo + Chemotherapy | 67 | |
| Combination Therapy (up to 4.5 Months) | STARTED | Combination Therapy: Farletuzumab + Chemotherapy | 63 | |
| Combination Therapy (up to 4.5 Months) | STARTED | Monotherapy: Placebo | 0 | |
| Combination Therapy (up to 4.5 Months) | STARTED | Monotherapy: Farletuzumab | 0 | |
| Combination Therapy (up to 4.5 Months) | COMPLETED | Combination Therapy: Placebo + Chemotherapy | 38 | |
| Combination Therapy (up to 4.5 Months) | COMPLETED | Combination Therapy: Farletuzumab + Chemotherapy | 28 | |
| Combination Therapy (up to 4.5 Months) | COMPLETED | Monotherapy: Placebo | 0 | |
| Combination Therapy (up to 4.5 Months) | COMPLETED | Monotherapy: Farletuzumab | 0 | |
| Combination Therapy (up to 4.5 Months) | NOT COMPLETED | Combination Therapy: Placebo + Chemotherapy | 29 | |
| Combination Therapy (up to 4.5 Months) | NOT COMPLETED | Combination Therapy: Farletuzumab + Chemotherapy | 35 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events1,628
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 | Deep vein thrombosis | Vascular disorders | Combination Therapy: Placebo + Chemotherapy | 4 | 65 | 4 |
| other | Deep vein thrombosis | Vascular disorders | Combination Therapy: Farletuzumab + Chemotherapy | 3 | 64 | 3 |
| other | Deep vein thrombosis | Vascular disorders | Monotherapy: Placebo | 0 | 35 | 0 |
| other | Deep vein thrombosis | Vascular disorders | Monotherapy: Farletuzumab | 1 | 31 | 1 |
| other | Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Combination Therapy: Placebo + Chemotherapy | 2 | 65 | 2 |
| other | Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Combination Therapy: Farletuzumab + Chemotherapy | 1 | 64 | 1 |
| other | Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Monotherapy: Placebo | 2 | 35 | 3 |
| other | Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Monotherapy: Farletuzumab | 0 | 31 | 0 |
| other | Asthenia | General disorders | Combination Therapy: Placebo + Chemotherapy | 12 | 65 | 13 |
| other | Asthenia | General disorders | Combination Therapy: Farletuzumab + Chemotherapy | 22 | 64 | 32 |
1 to 10 of 1,628Source ClinicalTrials.gov
See all 1,628 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination Therapy: Placebo + Chemotherapy | 46 | 65 |
| Total, all-cause mortality | Combination Therapy: Farletuzumab + Chemotherapy | 39 | 64 |
| Total, all-cause mortality | Monotherapy: Placebo | 1 | 35 |
| Total, all-cause mortality | Monotherapy: Farletuzumab | 0 | 31 |
| Total, other adverse events | Combination Therapy: Placebo + Chemotherapy | 60 | 65 |
| Total, other adverse events | Combination Therapy: Farletuzumab + Chemotherapy | 63 | 64 |
| Total, other adverse events | Monotherapy: Placebo | 30 | 35 |
| Total, other adverse events | Monotherapy: Farletuzumab | 25 | 31 |
| Total, serious adverse events | Combination Therapy: Placebo + Chemotherapy | 27 | 65 |
| Total, serious adverse events | Combination Therapy: Farletuzumab + Chemotherapy | 27 | 64 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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