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The purpose of this study is to compare disease response of Albumin-bound paclitaxel (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin-bound paclitaxel + Carboplatin | Experimental | Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. |
|
| Paclitaxel + Carboplatin | Active Comparator | Participants received 200 mg/m^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21 day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin-bound paclitaxel | Drug | Administered by intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment | Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target and non-target lesions and no new lesions. Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesions). | Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival by Blinded Radiology Assessment | Progression free survival time was defined as the time from the day of randomization to the start of disease progression or death (any cause), whichever occurred first, based on the blinded radiological review response assessment. Progressive disease was defined as a ≥ 20% increase in the SLD of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the presence of one or more new lesions, or the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesion(s). Participants who did not have disease progression or had not died were censored at the last visit they were documented as progression free. If palliative radiotherapy or surgery at lesion sites occurred, the participant was censored at the last date without documented progression prior to radiotherapy or surgery. In follow-up, participants who began new therapy prior to progression were censored at the last documented date as progression-free. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment, by Histology | Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target and non-target lesions and no new lesions. Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesions). Histology was determined at the time of primary diagnosis. |
Inclusion Criteria:
Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)
Male or non-pregnant and non-lactating female, and equal or greater than age 18
No other current active malignancy
Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion)
Patients must have received no prior chemotherapy for the treatment of metastatic disease. Adjuvant chemotherapy permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study
Patient has the following blood counts at baseline:
Patient has the following blood chemistry levels at baseline:
Expected survival of greater than 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Socinski, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clearview Cancer Institute Oncology Specialties, P.C. | Huntsville | Alabama | 35805 | United States | ||
| Genesis Cancer Center- Hot Springs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24467217 | Background | Hirsh V. nab-paclitaxel for the management of patients with advanced non-small-cell lung cancer. Expert Rev Anticancer Ther. 2014 Feb;14(2):129-41. doi: 10.1586/14737140.2014.881719. | |
| 25572008 | Background | Langer CJ, Hirsh V, Ko A, Renschler MF, Socinski MA. Weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: analysis of safety and efficacy in patients with renal impairment. Clin Lung Cancer. 2015 Mar;16(2):112-20. doi: 10.1016/j.cllc.2014.09.003. Epub 2014 Sep 30. |
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Eligible patients were randomized on Day 1 in a 1:1 ratio into 1 of 2 treatment arms and were required to start treatment within 7 days of randomization. The data below represent a cut-off of 31 January 2011. One patient was randomized twice and not included in the Intent-to-treat population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Albumin-bound Paclitaxel + Carboplatin | Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Paclitaxel | Drug | Administered by intravenous infusion. |
|
|
| Carboplatin | Drug | Administered by intravenous infusion. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate [GFR] + 25). For the purposes of this protocol, the GFR is considered to be equivalent to creatinine clearance (calculated by the method of Cockcroft and Gault, 1976). |
|
| Assessed every 6 weeks until progression or death, up to 38 months |
| Overall Participant Survival | Overall survival was defined as the time from the day of randomization to participant death (due to any cause), as assessed by post study follow-up performed monthly for 6 months and every 3 months thereafter for 12 months. All participants who were lost to the follow-up prior to the end of the trial or who completed the 18 month follow up phase were censored at last known time the participant was alive. | Up to 38 months |
| Percentage of Participants With Controlled Disease | Controlled disease was defined as the percentage of participants with stable disease for ≥ 16 weeks or confirmed complete or partial overall response, based on blinded radiological assessment. Stable disease was defined as neither sufficient shrinkage of target lesions to qualify for Partial Response, nor sufficient increase to qualify for Progressive Disease, or the persistence of one or more non-target lesions not qualifying for Complete Response or Progressive Disease. | Assessed every 6 weeks, up to 22 months |
| Duration of Response in Responding Patients | Duration of response was assessed by progression free survival for participants who achieved a confirmed complete response or partial response based on blinded radiological assessment. | Assessed every 6 weeks, up to 38 months |
| Number of Participants With Adverse Events (AEs) | A Treatment-emergent AE was any AE that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. Treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. | Up to 38 months |
| Pharmacokinetic (PK) Parameters | Blood samples for PK analyses were taken during Cycle 1 at 0.25, 3.5 and 24 hours post-infusion. |
| SPARC Status and Correlation With Overall Survival | The expression and cellular distribution of Secreted Protein Acidic and Rich in cysteine (SPARC) in biopsies of lung tumor was examined by immunohistochemistry using a 2 antibody system by an approved central laboratory and analyzed by 2 pathologists. The following tissue components were scored: tumor cells, fibroblasts, inflammatory cells, acellular stroma/matrix, and blood vessels. To classify participants into "high-SPARC" and "low-SPARC" groups, an average z-score was calculated across variables and classified "high-SPARC" (average z-scores ≥0) and "low-SPARC" (average z-scores <0) groups. SPARC status was then correlated with overall survival (the time from the day of randomization to participant death due to any cause). | Archival tissue samples were used for SPARC analysis. Survival was assessed for up to 38 months. |
| Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months. |
| Maximal Degree of Anemia Based on Clinical Laboratory Values for Hemoglobin | The maximal degree of anemia (and myelosuppression) was assessed by the overall nadir of hemoglobin levels based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. | 38 months |
| Maximal Degree of Neutropenia Based on Clinical Laboratory Values of Absolute Neutrophil Count | The maximal degree of neutropenia (and myelosuppression) was assessed by the overall nadir of absolute neutrophil count (ANC) based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. | 38 months |
| Maximal Degree of Thrombocytopenia Based on Clinical Laboratory Values of Platelet Count | The maximal degree of thrombocytopenia (and myelosuppression) was assessed by the overall nadir of platelet count based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. | 38 months |
| Time to Improvement of ≥ Grade 3 Treatment Related Peripheral Neuropathy | Peripheral neuropathy was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. Improvement in peripheral neuropathy was evaluated as:
Time to improvement was defined as the time from the first occurrence of grade 3 or higher treatment related neuropathy to improvement, as defined. Participants not experiencing improvement were censored at the last time the participant was evaluated for adverse events. | 38 months |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Little Rock Hematology Oncology Associates | Little Rock | Arkansas | 72205 | United States |
| Pacific Cancer Medical Center, Inc. | Anaheim | California | 92801 | United States |
| Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | United States |
| Southwest Cancer Care | Escondido | California | 92064 | United States |
| Robert A. Moss, MD, FACP, Inc. | Fountain Valley | California | 92708 | United States |
| Pacific Shores Medical Group | Long Beach | California | 90813 | United States |
| Ventura County Hematology-Oncology Specialists | Oxnard | California | 93030 | United States |
| Comprehensice Cancer Ctr. | Palms Springs | California | 92262 | United States |
| Gulf Coast Oncology Associates | St. Petersburg | Florida | 33705 | United States |
| Lake County Oncology and Hematology, PA | Tavares | Florida | 32778 | United States |
| Phoebe Cancer Center | Albany | Georgia | 31701 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| Kentuckiana Cancer Institute, PLLC | Louisville | Kentucky | 40202 | United States |
| Mercy Hospital | Portland | Maine | 04101 | United States |
| Maine Center for Cancer Medicine | Scarborough | Maine | 04074 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| St. Louis University | St Louis | Missouri | 63110 | United States |
| Essex Oncology of North Jersey | Belleville | New Jersey | 07109 | United States |
| Mary Imogene Bassett Hospital | Cooperstown | New York | 13326 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| St. Mary Medical Center- Oncology, Hematology PC | Langhorne | Pennsylvania | 19047 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Dallas Oncology Consultants, PA | Duncanville | Texas | 75137 | United States |
| The Center for Cancers and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | United States |
| Blood and Cancer Center of East Texas | Tyler | Texas | 75701 | United States |
| Tyler Hematology Oncology | Tyler | Texas | 75701 | United States |
| Fletcher Allen Health Care | Burlington | Vermont | 05405 | United States |
| Cancer Outreach Associates, PC | Abingdon | Virginia | 24211 | United States |
| Royal Columbian Hospital | New Westminster | British Columbia | V3L 3W4 | Canada |
| William Osler Health Centre, Brampton Clinic | Brampton | Ontario | L6R 3J7 | Canada |
| Toronto East General Hospital | Toronto | Ontario | M4C3E7 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University- Dept. of Oncology | Montreal | Quebec | H2W 1S6 | Canada |
| Hopital du Sacre-Coeur de Montreal | Montreal | Quebec | H4J 1C5 | Canada |
| 26035702 | Background | Langer CJ, Hirsh V, Okamoto I, Lin FJ, Wan Y, Whiting S, Ong TJ, Renschler MF, Botteman MF. Survival, quality-adjusted survival, and other clinical end points in older advanced non-small-cell lung cancer patients treated with albumin-bound paclitaxel. Br J Cancer. 2015 Jun 30;113(1):20-9. doi: 10.1038/bjc.2015.181. Epub 2015 Jun 2. |
| 22547591 | Result | Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2055-62. doi: 10.1200/JCO.2011.39.5848. Epub 2012 Apr 30. |
| 23123509 | Result | Socinski MA, Langer CJ, Okamoto I, Hon JK, Hirsh V, Dakhil SR, Page RD, Orsini J, Zhang H, Renschler MF. Safety and efficacy of weekly nab(R)-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell lung cancer. Ann Oncol. 2013 Feb;24(2):314-321. doi: 10.1093/annonc/mds461. Epub 2012 Nov 2. |
| 23545279 | Result | Satouchi M, Okamoto I, Sakai H, Yamamoto N, Ichinose Y, Ohmatsu H, Nogami N, Takeda K, Mitsudomi T, Kasahara K, Negoro S. Efficacy and safety of weekly nab-paclitaxel plus carboplatin in patients with advanced non-small cell lung cancer. Lung Cancer. 2013 Jul;81(1):97-101. doi: 10.1016/j.lungcan.2013.02.020. Epub 2013 Mar 30. |
| 23842283 | Result | Socinski MA, Okamoto I, Hon JK, Hirsh V, Dakhil SR, Page RD, Orsini J, Yamamoto N, Zhang H, Renschler MF. Safety and efficacy analysis by histology of weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer. Ann Oncol. 2013 Sep;24(9):2390-6. doi: 10.1093/annonc/mdt235. Epub 2013 Jul 10. |
| 24346096 | Result | Hirsh V, Okamoto I, Hon JK, Page RD, Orsini J, Sakai H, Zhang H, Renschler MF, Socinski MA. Patient-reported neuropathy and taxane-associated symptoms in a phase 3 trial of nab-paclitaxel plus carboplatin versus solvent-based paclitaxel plus carboplatin for advanced non-small-cell lung cancer. J Thorac Oncol. 2014 Jan;9(1):83-90. doi: 10.1097/JTO.0000000000000011. |
| 37922432 | Derived | Loureiro H, Kolben TM, Kiermaier A, Ruttinger D, Ahmidi N, Becker T, Bauer-Mehren A. Correlation Between Early Trends of a Prognostic Biomarker and Overall Survival in Non-Small-Cell Lung Cancer Clinical Trials. JCO Clin Cancer Inform. 2023 Sep;7:e2300062. doi: 10.1200/CCI.23.00062. |
| FG001 | Paclitaxel + Carboplatin | Participants received 200 mg/m^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. |
| Treated |
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| Biomarker Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Albumin-bound Paclitaxel + Carboplatin | Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. |
| BG001 | Paclitaxel + Carboplatin | Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Smoking status | Number | participants |
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| Eastern Cooperative Oncology Group (ECOG) Performance Status | A scale used to assess the progress of disease in a patient, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. | Number | participants |
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| Time from Primary Diagnosis to Study Entry | Mean | Standard Deviation | months |
| |||||||||||||||
| Stage at Primary Diagnosis | I: The tumor has not spread outside the chest or to the lymph nodes. II: A tumor that may have spread to local lymph nodes, but has not spread further. IIIa: A tumor of any size, cancer cells are found in the lymph nodes near the lungs and bronchi and in the lymph nodes between the lungs on the same side of the chest. IIIb: Any size tumor that has spread to distant lymph nodes, or invaded other structures in the chest such as the heart or esophagus, or a tumor with a malignant pleural effusion. IV - The cancer has spread to another part of the body, including the opposite lung. | Number | participants |
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| Anatomic Site of Primary Diagnosis | Number | participants |
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| Histology of Primary Diagnosis | Number | participants |
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| Time from 1st Documented Metastasis/Relapse to Study Entry | Mean | Standard Deviation | months |
| |||||||||||||||
| Stage at Randomization | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment | Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target and non-target lesions and no new lesions. Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesions). | The intent-to-treat population which includes all randomized patients regardless of whether the patient received any study drug or had any efficacy assessments collected. | Posted | Number | 95% Confidence Interval | percentage of participants | Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months. |
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| Secondary | Progression-free Survival by Blinded Radiology Assessment | Progression free survival time was defined as the time from the day of randomization to the start of disease progression or death (any cause), whichever occurred first, based on the blinded radiological review response assessment. Progressive disease was defined as a ≥ 20% increase in the SLD of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the presence of one or more new lesions, or the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesion(s). Participants who did not have disease progression or had not died were censored at the last visit they were documented as progression free. If palliative radiotherapy or surgery at lesion sites occurred, the participant was censored at the last date without documented progression prior to radiotherapy or surgery. In follow-up, participants who began new therapy prior to progression were censored at the last documented date as progression-free. | Intent-to-treat | Posted | Median | 95% Confidence Interval | months | Assessed every 6 weeks until progression or death, up to 38 months |
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| Secondary | Overall Participant Survival | Overall survival was defined as the time from the day of randomization to participant death (due to any cause), as assessed by post study follow-up performed monthly for 6 months and every 3 months thereafter for 12 months. All participants who were lost to the follow-up prior to the end of the trial or who completed the 18 month follow up phase were censored at last known time the participant was alive. | Intent-to-treat | Posted | Median | 95% Confidence Interval | months | Up to 38 months |
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| Secondary | Percentage of Participants With Controlled Disease | Controlled disease was defined as the percentage of participants with stable disease for ≥ 16 weeks or confirmed complete or partial overall response, based on blinded radiological assessment. Stable disease was defined as neither sufficient shrinkage of target lesions to qualify for Partial Response, nor sufficient increase to qualify for Progressive Disease, or the persistence of one or more non-target lesions not qualifying for Complete Response or Progressive Disease. | Intent-to-treat | Posted | Number | 95% Confidence Interval | percentage of participants | Assessed every 6 weeks, up to 22 months |
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| Secondary | Duration of Response in Responding Patients | Duration of response was assessed by progression free survival for participants who achieved a confirmed complete response or partial response based on blinded radiological assessment. | Intent-to-treat patients with an objective response. | Posted | Median | 95% Confidence Interval | months | Assessed every 6 weeks, up to 38 months |
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| Secondary | Number of Participants With Adverse Events (AEs) | A Treatment-emergent AE was any AE that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. Treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. | Treated population | Posted | Number | participants | Up to 38 months |
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| Secondary | Pharmacokinetic (PK) Parameters | Patients randomized to receive albumin-bound paclitaxel/carboplatin treatment in Canada, Russia, Ukraine and United States had the option to participate in sparse PK sampling in this study. Only 15 participants consented to participate, an insufficient number to support the planned population PK analysis hence these analyses were not performed. | Posted | Blood samples for PK analyses were taken during Cycle 1 at 0.25, 3.5 and 24 hours post-infusion. |
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| Secondary | SPARC Status and Correlation With Overall Survival | The expression and cellular distribution of Secreted Protein Acidic and Rich in cysteine (SPARC) in biopsies of lung tumor was examined by immunohistochemistry using a 2 antibody system by an approved central laboratory and analyzed by 2 pathologists. The following tissue components were scored: tumor cells, fibroblasts, inflammatory cells, acellular stroma/matrix, and blood vessels. To classify participants into "high-SPARC" and "low-SPARC" groups, an average z-score was calculated across variables and classified "high-SPARC" (average z-scores ≥0) and "low-SPARC" (average z-scores <0) groups. SPARC status was then correlated with overall survival (the time from the day of randomization to participant death due to any cause). | SPARC biomarker Population | Posted | Number | participants | Archival tissue samples were used for SPARC analysis. Survival was assessed for up to 38 months. |
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| Other Pre-specified | Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment, by Histology | Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target and non-target lesions and no new lesions. Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesions). Histology was determined at the time of primary diagnosis. | The intent-to-treat population. N indicates the number of participants in each histology category for each treatment arm respectively. | Posted | Number | percentage of participants | Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months. |
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| Other Pre-specified | Maximal Degree of Anemia Based on Clinical Laboratory Values for Hemoglobin | The maximal degree of anemia (and myelosuppression) was assessed by the overall nadir of hemoglobin levels based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. | Treated population where laboratory data were available. | Posted | Mean | Standard Deviation | g/L | 38 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Maximal Degree of Neutropenia Based on Clinical Laboratory Values of Absolute Neutrophil Count | The maximal degree of neutropenia (and myelosuppression) was assessed by the overall nadir of absolute neutrophil count (ANC) based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. | Treated population where laboratory data were available. | Posted | Mean | Standard Deviation | × 10^9/L | 38 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Maximal Degree of Thrombocytopenia Based on Clinical Laboratory Values of Platelet Count | The maximal degree of thrombocytopenia (and myelosuppression) was assessed by the overall nadir of platelet count based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. | Treated population where laboratory data were available. | Posted | Mean | Standard Deviation | × 10^9/L | 38 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to Improvement of ≥ Grade 3 Treatment Related Peripheral Neuropathy | Peripheral neuropathy was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. Improvement in peripheral neuropathy was evaluated as:
Time to improvement was defined as the time from the first occurrence of grade 3 or higher treatment related neuropathy to improvement, as defined. Participants not experiencing improvement were censored at the last time the participant was evaluated for adverse events. | Treated population with ≥ grade 3 treatment-related peripheral neuropathy. | Posted | Median | 95% Confidence Interval | days | 38 months |
|
Up to 38 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Albumin-bound Paclitaxel + Carboplatin | Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. | 93 | 514 | 483 | 514 | ||
| EG001 | Paclitaxel + Carboplatin | Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. | 80 | 524 | 499 | 524 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Injection site abscess | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pleural haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Inguinal hernia strangulated | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Superior vena caval occlusion | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Influenza serology | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
Institution may publish the results of its findings if a multicenter publication is not forthcoming within 18 months after study completion. Institution shall provide Celgene with a copy of the papers prior to their submission; Celgene shall complete its review within 60 days after receipt. Upon Celgene's request, proposed publication or presentation will be delayed up to 60 additional days to enable Celgene to secure adequate intellectual property protection of patentable material.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials Disclosure | Celgene Corporation | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Male |
|
| Black, of African Heritage |
|
| North American Indian or Alaska Native |
|
| White, Non Hispanic and Non Latino |
|
| White, Hispanic or Latino |
|
| Other |
|
| Canada |
|
| Australia |
|
| Japan |
|
| Russian Federation |
|
| Ukraine |
|
| Smoked and quit smoking |
|
| Smoked and currently smokes |
|
| Missing |
|
| 1 (Restrictive but ambulatory) |
|
| 2 (Ambulatory but unable to work) |
|
| II |
|
| IIIa |
|
| IIIb |
|
| IV |
|
| Unknown |
|
| Other |
|
| Squamous Cell Carcinoma |
|
| Large Cell Carcinoma |
|
| Other |
|
| IV |
|
| OG001 | Paclitaxel + Carboplatin | Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG001 | Paclitaxel + Carboplatin | Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. |
|
|
|
| OG001 | Paclitaxel + Carboplatin | Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. |
|
|
|
|
|
|
|
|
|
| Paclitaxel + Carboplatin |
Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent. |
|
|