Trial · NCT02027428
Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer
NCT02027428, Phase 3, Completed, Celgene; results first posted 2018-12-07
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ConductScience Library. Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer. Trials, record NCT02027428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02027428
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer
- NCT number
- NCT02027428
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 427 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Squamous Cell Carcinoma, Non-Small-Cell Lung
- Interventions
- Abraxane (Induction), Carboplatin (Induction), Abraxane (Maintenance), Best Supportive Care (Maintenance), Abraxane (Induction), Carboplatin (Induction), Best Supportive Care (Maintenance)
- First posted
- 2014-01-06
- Last updated
- 2020-08-17
- Other registries' IDs
- eudract:2014-003804-66
- Results first posted
- 2018-12-07
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kaplan-Meier Estimate of Progression-Free Survival (PFS) From Randomization Into Maintenance | From the date of randomization to the date of disease progression or death of any cause; up to data cut off date of 15 September 2017; up to 27.6 months | Progression-free survival is defined as the time in months from the date of randomization to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by computerized axial tomography \[CT scan\], not including symptomatic deterioration) or death (any cause) on or prior to 01 Aug 2019. RECIST 1.1 Definition: - Complete response (CR) -disappearance of all target lesions; - Partial response (PR) -at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease (SD) -neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase of lesions to qualify for progressive disease (PD) - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir, and/or the appearance of new lesions. |
| Secondary | Kaplan-Meier Estimate of Overall Survival (OS) From Randomization Into Maintenance | From the date of randomization to death from any cause; up to 01 August 2019; survival follow up was 55.89 months | Overall survival was defined as the duration in months between randomization and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off (01 August 2019 whichever was earlier. The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive. |
| Secondary | Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) Over Entire Study | Day 1 of treatment in the induction period and subsequent anticancer therapy, death or discontinuation up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study | Overall response was defined as the percentage of participants with a confirmed assessment of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and confirmed in no less than 28 days. The 95% confidence interval (CI) was calculated using Clopper-Pearson method. RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to \< 10 mm. - Partial response-at least a 30% decrease in the sum of diameters of target lesions from baseline. |
| Secondary | Kaplan-Meier Estimate of Progression-Free Survival (PFS) Over Entire Study | Between Day 1 of the Induction Part through to the date of disease progression or death; up to 01 August 2019; the maximum treatment duration was 234.1 weeks for entire study | PFS was defined as the time in months from Day 1 of treatment for the Induction part to the date of disease progression according to RECIST 1.1 criteria (documented by CT-scan, not including symptomatic deterioration) or death (any cause) on or prior to 01 August 2019, whichever occurred earlier. RECIST 1.1 Definition: - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of new lesions is also considered progression. |
| Secondary | Kaplan-Meier Estimate of Overall Survival (OS) Over Entire Study | Between Day 1 of treatment in the Induction Part to death from any cause; up to 01 August 2019; survival follow up was 55.89 months | Overall survival was defined as the time in months from Day 1 of treatment for the Induction part to death from any cause. Subjects who were alive at the time of analysis had their OS censored at the date or last contact of 01 August 2019, whichever was earlier. The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive. |
| Secondary | Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) In Maintenance Beyond the Response in Induction | For the induction period the maximum treatment was 19 weeks for the maintenance period the maximum treatment was 150 weeks. | Overall response in the maintenance period was defined as the percentage of participants who showed an improvement in best overall response from stable disease (SD) or partial response (PR) during Induction to a Complete Response (CR) or PR during Maintenance according to RECIST 1.1 criteria and confirmed in no less than 28 days. Evaluation takes as reference the lesion measurement or status at the last tumor assessment before randomization to Maintenance. The 95% CI was calculated using Clopper-Pearson method. RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. - Partial response-at least a 30% decrease in the sum of diameters of target lesions from baseline. - Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. |
| Secondary | Percentage of Participants Who Achieved Disease Control (Disease Control Rate) by Investigator Assessment During Induction and Over the Entire Study | Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 induction through maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study | Disease control rate was defined as the percentage of participants who had radiologic CR, PR or SD for \>= 6 weeks according to RECIST 1.1 criteria as determined by the investigator. Only participants with a confirmed CR/PR are included in this summary. Two timeframes are offered: - Time to confirmed response within the Induction timeframe. - Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study. RECIST 1.1 Definition: - CR- disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to \< 10 mm. - PR- at least a 30% decrease in the sum of diameters of target lesions from baseline; - SD- neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for PD. The 95% CI was calculated using Clopper-Pearson method. |
| Secondary | Time to Confirmed Response During Induction and Over the Entire Study | Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 Induction through Maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study | Time to confirmed complete or partial response (CR/PR) is defined as the time from day 1 of treatment in Induction to the first occurrence of confirmed CR/PR. Two timeframes are offered: - Time to confirmed response within the Induction timeframe. - Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study. Only participants with a confirmed CR or PR are included in this summary. |
| Secondary | Kaplan-Meier Estimate for Duration of Response Over the Entire Study | Between Day 1 of the Induction Period through to the date of disease progression or death; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study. | Duration of overall response was measured from the time criteria were first met for CR/PR until the first date the recurrent or progressive disease (PD) was radiologically documented. Participants who did not have PD after the response were censored on the date of last tumor assessment. If a participant died before PD, the participant was censored on the date of death. |
| Secondary | Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period | Day 1 of Induction up to Week 23 (maximum treatment in Induction plus 4 weeks if not continuing into Maintenance) | TEAE in the Induction part is defined as any adverse event (AE) with an onset on or after Day 1 of treatment for the Induction part, and on or before the day of randomization for subjects who entered into the Maintenance part, or, for subjects who did not enter into the Maintenance part, before the treatment discontinuation date plus 28 days or any serious AE which occurred thereafter but was determined to be related to any study drug by the investigator. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild, Grade 2 = Moderate Grade, 3 = Severe Grade, 4 = Life threatening, Grade 5 = Death. Relation to study drug was determined by the investigator. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Kaplan-Meier Estimate of Progression-Free Survival (PFS) From Randomization Into Maintenance | From the date of randomization to the date of disease progression or death of any cause; up to data cut off date of 15 September 2017; up to 27.6 months | Intent to treat (ITT) population of participants randomized to Maintenance. The ITT population in the Maintenance part included all randomized subjects regardless of whether the subject received any study drug or had any efficacy assessments collected. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate of Overall Survival (OS) From Randomization Into Maintenance | From the date of randomization to death from any cause; up to 01 August 2019; survival follow up was 55.89 months | Intent to Treat population of participants randomized to maintenance. | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) Over Entire Study | Day 1 of treatment in the induction period and subsequent anticancer therapy, death or discontinuation up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study | Intent to treat population of participants randomized to Maintenance | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Progression-Free Survival (PFS) Over Entire Study | Between Day 1 of the Induction Part through to the date of disease progression or death; up to 01 August 2019; the maximum treatment duration was 234.1 weeks for entire study | Intent to treat population of participants randomized to Maintenance | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate of Overall Survival (OS) Over Entire Study | Between Day 1 of treatment in the Induction Part to death from any cause; up to 01 August 2019; survival follow up was 55.89 months | ITT population of participants randomized to Maintenance. | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) In Maintenance Beyond the Response in Induction | For the induction period the maximum treatment was 19 weeks for the maintenance period the maximum treatment was 150 weeks. | Intent to treat population of participants randomized to the maintenance period. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Disease Control (Disease Control Rate) by Investigator Assessment During Induction and Over the Entire Study | Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 induction through maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study | Induction includes the ITT population of participants treated during Induction. Entire Study includes the entire experience of the ITT population of participants randomized to maintenance. | percentage of participants | NUMBER |
| SECONDARY | Time to Confirmed Response During Induction and Over the Entire Study | Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 Induction through Maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study | Includes the ITT population of participants who had a response. Induction includes the ITT population of participants treated during Induction who had a response. Induction+Maintenance includes the ITT population of participants randomized to Maintenance who had a response. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate for Duration of Response Over the Entire Study | Between Day 1 of the Induction Period through to the date of disease progression or death; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study. | The ITT population of participants randomized to the maintenance period and had a confirmed partial or complete response. | months | MEDIAN |
| SECONDARY | Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period | Day 1 of Induction up to Week 23 (maximum treatment in Induction plus 4 weeks if not continuing into Maintenance) | Safety population of participants treated during induction period. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group152
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kaplan-Meier Estimate of Progression-Free Survival (PFS) From Randomization Into Maintenance | Nab-Paclitaxel + Best Supportive Care (BSC) | 3.12 | 95% Confidence Interval 2.73 to 4.60 | months | |
| Kaplan-Meier Estimate of Progression-Free Survival (PFS) From Randomization Into Maintenance | Best Supportive Care (BSC) | 2.60 | 95% Confidence Interval 1.64 to 3.45 | months | |
| Kaplan-Meier Estimate of Overall Survival (OS) From Randomization Into Maintenance | Nab-Paclitaxel + Best Supportive Care (BSC) | 17.61 | 95% Confidence Interval 13.86 to 21.09 | months | |
| Kaplan-Meier Estimate of Overall Survival (OS) From Randomization Into Maintenance | Best Supportive Care (BSC) | 12.16 | 95% Confidence Interval 7.56 to 18.99 | months | |
| Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) Over Entire Study | Nab-Paclitaxel + BSC: Induction + Maintenance | 69.1 | 95% Confidence Interval 60.6 to 76.8 | percentage of participants | |
| Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) Over Entire Study | BSC: Induction + Maintenance | 57.6 | 95% Confidence Interval 44.8 to 69.7 | percentage of participants | |
| Kaplan-Meier Estimate of Progression-Free Survival (PFS) Over Entire Study | Nab-Paclitaxel + BSC: Induction + Maintenance | 6.47 | 95% Confidence Interval 5.65 to 7.79 | months | |
| Kaplan-Meier Estimate of Progression-Free Survival (PFS) Over Entire Study | BSC: Induction + Maintenance | 5.55 | 95% Confidence Interval 4.96 to 6.67 | months | |
| Kaplan-Meier Estimate of Overall Survival (OS) Over Entire Study | Nab-Paclitaxel + BSC: Induction + Maintenance | 20.57 | 95% Confidence Interval 17.05 to 24.05 | months | |
| Kaplan-Meier Estimate of Overall Survival (OS) Over Entire Study | BSC: Induction + Maintenance | 15.05 | 95% Confidence Interval 10.81 to 22.14 | months |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction | STARTED | All Participants - Induction | 427 | |
| Induction | STARTED | Nab-Paclitaxel + Best Supportive Care (BSC) | 0 | |
| Induction | STARTED | Best Supportive Care (BSC) | 0 | |
| Induction | Received Study Drug | All Participants - Induction | 420 | |
| Induction | Received Study Drug | Nab-Paclitaxel + Best Supportive Care (BSC) | 0 | |
| Induction | Received Study Drug | Best Supportive Care (BSC) | 0 | |
| Induction | COMPLETED | All Participants - Induction | 202 | |
| Induction | COMPLETED | Nab-Paclitaxel + Best Supportive Care (BSC) | 0 | |
| Induction | COMPLETED | Best Supportive Care (BSC) | 0 | |
| Induction | NOT COMPLETED | All Participants - Induction | 225 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events630
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 | All Participants - Induction | 256 | 420 | |
| other | Anaemia | Blood and lymphatic system disorders | Nab-Paclitaxel + Best Supportive Care (Maintenance) | 24 | 130 | |
| other | Anaemia | Blood and lymphatic system disorders | Best Supportive Care (Maintenance) | 6 | 62 | |
| other | Leukopenia | Blood and lymphatic system disorders | All Participants - Induction | 80 | 420 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nab-Paclitaxel + Best Supportive Care (Maintenance) | 1 | 130 | |
| other | Leukopenia | Blood and lymphatic system disorders | Best Supportive Care (Maintenance) | 1 | 62 | |
| other | Neutropenia | Blood and lymphatic system disorders | All Participants - Induction | 225 | 420 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nab-Paclitaxel + Best Supportive Care (Maintenance) | 14 | 130 | |
| other | Neutropenia | Blood and lymphatic system disorders | Best Supportive Care (Maintenance) | 0 | 62 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | All Participants - Induction | 163 | 420 |
1 to 10 of 630Source ClinicalTrials.gov
See all 630 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants - Induction | 80 | 420 |
| Total, all-cause mortality | Nab-Paclitaxel + Best Supportive Care (Maintenance) | 82 | 130 |
| Total, all-cause mortality | Best Supportive Care (Maintenance) | 48 | 62 |
| Total, other adverse events | All Participants - Induction | 417 | 420 |
| Total, other adverse events | Nab-Paclitaxel + Best Supportive Care (Maintenance) | 122 | 130 |
| Total, other adverse events | Best Supportive Care (Maintenance) | 45 | 62 |
| Total, serious adverse events | All Participants - Induction | 177 | 420 |
| Total, serious adverse events | Nab-Paclitaxel + Best Supportive Care (Maintenance) | 32 | 130 |
| Total, serious adverse events | Best Supportive Care (Maintenance) | 13 | 62 |
Source ClinicalTrials.gov
Papers35
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 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.
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