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The study terminated before Phase 1 was completed. This study was reprioritized within the rociletinib development program.
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This clinical research study is being carried out in two parts, Phase 1 and Phase 2. The primary purpose of the Phase 1 portion of the study is to observe the safety of the combination of rociletinib and MPDL3280A in EGFR-mutant NSCLC patients.
The primary purpose of the Phase 2 portion of the study is to evaluate the safety and anti-tumor effects of the combination of rociletinib and MPDL3280A, at the best doses for the combination determined in Phase 1, in patients with EGFR-mutant NSCLC.
This is a Phase 1b/2, open-label, non-randomized, multicenter study evaluating the safety and efficacy of rociletinib administered in combination with MPDL3280A.
Phase 1: This will be the dose finding phase of the study. Patients will be enrolled to available Dosing Cohort. Patients who have progressed after prior first- or second-generation EGFR TKI, regardless of T790M mutation status, will be enrolled.
Phase 2: Patients will be enrolled into 2 groups. Group A will enroll eligible first-line patients who are EGFR TKI treatment-naïve and chemotherapy-naïve. Group B will enroll eligible patients who have progressed after prior first- or second-generation EGFR TKI, regardless of T790M mutation status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Rociletinib and MPDL3280A | Experimental | Specific doses of rociletinib, taken continuously BID, will be administered in combination with a fixed dose of MPDL3280A, given intravenously on Day 1 of each 21-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rociletinib | Drug | A novel, potent, covalent (irreversible) small molecule, tyrosine kinase inhibitor (TKI) administered orally (PO) to patients with EGFRm NSCLC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-emergent Adverse Events, as Assessed by NCI CTCAE v4.03 | The safety analyses will be performed using the safety population. Safety data analysis will be conducted on all patients receiving at least one dose of rociletinib or MPDL3280A. | Continuously, up to approximately 18.5 months |
| Maximum Concentration (Cmax) of Rociletinib and Its Metabolites | Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmax will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. | Treatment Day 1 and Day 15 |
| Time to Maximum Concentration (Tmax) for Rociletinib and Rociletinib Metabolites | Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Tmax will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. | Treatment Day 1 and Day 15 |
| Minimum Concentration (Cmin) of Rociletinib and Metabolites | Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmin will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. | Approximately every 6 weeks up to 24 months |
| Area Under the Curve (AUC) of Rociletinib and Rociletinib Metabolites | Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. AUC0 24 will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate Per Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2 | Conventional response criteria may not be adequate to characterize the antitumor activity of immunotherapeutic agents like MPDL3280A, which can produce delayed responses that may be preceded by initial apparent radiological progression, including the appearance of new lesions. Therefore, modified response criteria have been developed that account for the possible appearance of new lesions and allow radiological progression to be confirmed at a subsequent assessment. In this protocol, patients will be permitted to continue study treatment even after modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease are met if the benefit-risk ratio is judged to be favorable. These modified criteria are derived from RECIST version 1.1 (v1.1) conventions and immune related response criteria (irRC). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsey Rolfe, MD | Clovis Oncology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Los Angeles | Santa Monica | California | 90404 | United States |
The Dose Finding Phase included a 7 day Run in Period of rociletinib monotherapy, at the Dosing Cohort-defined dose level, prior to the initiation of combination treatment.
Three patients were enrolled at a single center in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Rociletinib and MPDL3280A in Combination | Rociletinib (CO-1686), a novel, potent, covalent (irreversible) small molecule, tyrosine kinase inhibitor (TKI) administered orally (PO) to patients with EGFRm NSCLC in combination with MPDL3280A, a human IgG1 monoclonal antibody administered intravenously (IV). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 26, 2015 |
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|
| MPDL3280A | Drug | A human IgG1 monoclonal antibody administered intravenously (IV) |
|
|
| Treatment Day 1 and Day 8 |
| Maximum Concentration (Cmax) of MPDL3280A | Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmax, for MPDL3280A will be assessed using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. | Cycle 1 Day 1 |
| Minimum Concentration (Cmin) of MPDL3280A | Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmin for MPDL3280A will be assessed using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. | Approximately every 6 weeks up to 24 months |
| Objective Response Rate Per RECIST v1.1 in Phase 2 | To determine the efficacy of the combination of rociletinib and MPDL3280A based on overall response rate per RECIST v1.1 in the following groups of patients:
| Approximately every 6-9 weeks |
| Approximately every 6-9 weeks, up to 24 months |
| Duration of Response Per RECIST v1.1 and Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2 | Conventional response criteria may not be adequate to characterize the antitumor activity of immunotherapeutic agents like MPDL3280A, which can produce delayed responses that may be preceded by initial apparent radiological progression, including the appearance of new lesions. Therefore, modified response criteria have been developed that account for the possible appearance of new lesions and allow radiological progression to be confirmed at a subsequent assessment. In this protocol, patients will be permitted to continue study treatment even after modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease are met if the benefit-risk ratio is judged to be favorable. These modified criteria are derived from RECIST version 1.1 (v1.1) conventions and immune related response criteria (irRC). | Approximately every 6-9 weeks, up to 24 months |
| Progression-free Survival Per RECIST v1.1 and Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2 | Conventional response criteria may not be adequate to characterize the antitumor activity of immunotherapeutic agents like MPDL3280A, which can produce delayed responses that may be preceded by initial apparent radiological progression, including the appearance of new lesions. Therefore, modified response criteria have been developed that account for the possible appearance of new lesions and allow radiological progression to be confirmed at a subsequent assessment. In this protocol, patients will be permitted to continue study treatment even after modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease are met if the benefit-risk ratio is judged to be favorable. These modified criteria are derived from RECIST version 1.1 (v1.1) conventions and immune related response criteria (irRC). | Approximately every 6-9 weeks, up to 24 months |
| Number of Patients Alive at Study Termination | Patients who received the combination of rociletinib and MPDL3280A alive at the termination of this study. | Up to approximately 18.5 months |
| Longitudinal Changes in Blood Based Biomarkers (eg, Mutations in EGFR) in ctDNA | Tumor tissue, plasma, and blood specimens will be used for pharmacodynamic assessment of rociletinib and/or MPDL3280A activity, to evaluate the concordance of mutant EGFR detection between tissue and plasma, and to explore biomarkers that may be predictive of response or resistance to rociletinib and/or MPDL3280A. Biomarkers and changes in biomarker status will be investigated for associations with rociletinib and/or MPDL3280A exposure, safety, and clinical activity. Given the limited sample size, no formal statistical analysis is planned. | Blood samples will be collected from each patient approximately every 3 weeks, up to 24 months |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Rociletinib and MPDL3280A in Combination | Rociletinib (CO-1686), a novel, potent, covalent (irreversible) small molecule, tyrosine kinase inhibitor (TKI) administered orally (PO) to patients with EGFRm NSCLC in combination with MPDL3280A, a human IgG1 monoclonal antibody administered intravenously (IV). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | 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 | Number of Treatment-emergent Adverse Events, as Assessed by NCI CTCAE v4.03 | The safety analyses will be performed using the safety population. Safety data analysis will be conducted on all patients receiving at least one dose of rociletinib or MPDL3280A. | All patients enrolled in the study. | Posted | Number | Treatment emergent adverse events | Continuously, up to approximately 18.5 months |
|
|
| ||||||||||||||||||||||||||
| Primary | Maximum Concentration (Cmax) of Rociletinib and Its Metabolites | Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmax will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. | Due to the small number of patients enrolled and small number of PK samples collected as a result of early termination of the study, these analyses were not conducted. | Posted | Treatment Day 1 and Day 15 |
|
| |||||||||||||||||||||||||||||
| Primary | Time to Maximum Concentration (Tmax) for Rociletinib and Rociletinib Metabolites | Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Tmax will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. | Due to the small number of patients enrolled and small number of PK samples collected as a result of early termination of the study, these analyses were not conducted. | Posted | Treatment Day 1 and Day 15 |
|
| |||||||||||||||||||||||||||||
| Primary | Minimum Concentration (Cmin) of Rociletinib and Metabolites | Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmin will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. | Due to the small number of patients enrolled and small number of PK samples collected as a result of early termination of the study, these analyses were not conducted. | Posted | Approximately every 6 weeks up to 24 months |
|
| |||||||||||||||||||||||||||||
| Primary | Area Under the Curve (AUC) of Rociletinib and Rociletinib Metabolites | Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. AUC0 24 will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. | Due to the small number of patients enrolled and small number of PK sample collected as a result of early termination of the study, these analyses were not conducted. | Posted | Treatment Day 1 and Day 8 |
|
| |||||||||||||||||||||||||||||
| Primary | Maximum Concentration (Cmax) of MPDL3280A | Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmax, for MPDL3280A will be assessed using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. | Due to the small number of patients enrolled and small number of PK samples collected as a result of early termination of the study, these analyses were not conducted. | Posted | Cycle 1 Day 1 |
|
| |||||||||||||||||||||||||||||
| Primary | Minimum Concentration (Cmin) of MPDL3280A | Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmin for MPDL3280A will be assessed using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. | Due to the small number of patients enrolled and small number of PK samples collected as a result of early termination of the study, these analyses were not conducted. | Posted | Approximately every 6 weeks up to 24 months |
|
| |||||||||||||||||||||||||||||
| Primary | Objective Response Rate Per RECIST v1.1 in Phase 2 | To determine the efficacy of the combination of rociletinib and MPDL3280A based on overall response rate per RECIST v1.1 in the following groups of patients:
| Given the early termination of the study and that no patients were enrolled in Phase 2 of the study, no conclusions can be drawn. | Posted | Approximately every 6-9 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Objective Response Rate Per Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2 | Conventional response criteria may not be adequate to characterize the antitumor activity of immunotherapeutic agents like MPDL3280A, which can produce delayed responses that may be preceded by initial apparent radiological progression, including the appearance of new lesions. Therefore, modified response criteria have been developed that account for the possible appearance of new lesions and allow radiological progression to be confirmed at a subsequent assessment. In this protocol, patients will be permitted to continue study treatment even after modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease are met if the benefit-risk ratio is judged to be favorable. These modified criteria are derived from RECIST version 1.1 (v1.1) conventions and immune related response criteria (irRC). | Given the early termination of the study and that no patients were enrolled in Phase 2 of the study, no conclusions can be drawn. | Posted | Approximately every 6-9 weeks, up to 24 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Response Per RECIST v1.1 and Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2 | Conventional response criteria may not be adequate to characterize the antitumor activity of immunotherapeutic agents like MPDL3280A, which can produce delayed responses that may be preceded by initial apparent radiological progression, including the appearance of new lesions. Therefore, modified response criteria have been developed that account for the possible appearance of new lesions and allow radiological progression to be confirmed at a subsequent assessment. In this protocol, patients will be permitted to continue study treatment even after modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease are met if the benefit-risk ratio is judged to be favorable. These modified criteria are derived from RECIST version 1.1 (v1.1) conventions and immune related response criteria (irRC). | Given the early termination of the study and that no patients were enrolled in Phase 2 of the study, no conclusions can be drawn. | Posted | Approximately every 6-9 weeks, up to 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival Per RECIST v1.1 and Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2 | Conventional response criteria may not be adequate to characterize the antitumor activity of immunotherapeutic agents like MPDL3280A, which can produce delayed responses that may be preceded by initial apparent radiological progression, including the appearance of new lesions. Therefore, modified response criteria have been developed that account for the possible appearance of new lesions and allow radiological progression to be confirmed at a subsequent assessment. In this protocol, patients will be permitted to continue study treatment even after modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease are met if the benefit-risk ratio is judged to be favorable. These modified criteria are derived from RECIST version 1.1 (v1.1) conventions and immune related response criteria (irRC). | Given the early termination of the study and that no patients were enrolled in Phase 2 of the study, no conclusions can be drawn. | Posted | Approximately every 6-9 weeks, up to 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Patients Alive at Study Termination | Patients who received the combination of rociletinib and MPDL3280A alive at the termination of this study. | Count of the number of enrolled patients alive at study termination. | Posted | Number | participants | Up to approximately 18.5 months |
|
| |||||||||||||||||||||||||||
| Secondary | Longitudinal Changes in Blood Based Biomarkers (eg, Mutations in EGFR) in ctDNA | Tumor tissue, plasma, and blood specimens will be used for pharmacodynamic assessment of rociletinib and/or MPDL3280A activity, to evaluate the concordance of mutant EGFR detection between tissue and plasma, and to explore biomarkers that may be predictive of response or resistance to rociletinib and/or MPDL3280A. Biomarkers and changes in biomarker status will be investigated for associations with rociletinib and/or MPDL3280A exposure, safety, and clinical activity. Given the limited sample size, no formal statistical analysis is planned. | Due to the small number of patients enrolled and small number of samples collected as a result of early termination of the study, these analyses were not conducted. | Posted | Blood samples will be collected from each patient approximately every 3 weeks, up to 24 months |
|
|
Adverse events were reported from the date of first dose of study drug and until 28 days after the last dose of study drug.
One patient withdrew consent during the washout period having only received rociletinib. This patient did not receive MPDL3280A.
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 | Single Arm Rociletinib and MPDL3280A in Combination | Rociletinib (CO-1686), a novel, potent, covalent (irreversible) small molecule, tyrosine kinase inhibitor (TKI) administered orally (PO) to patients with EGFRm NSCLC in combination with MPDL3280A, a human IgG1 monoclonal antibody administered intravenously (IV). | 0 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Increased Blood Sugar | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Stomach Pain | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Muscle Cramps | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Prolonged QTc interval | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Intermittent epigastric discomfort | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Stomach Pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Epigastric pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Bilateral hearing loss | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Firm raised lesion, dorsum of left foot | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cataracts | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Swelling finger | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Elevated aspartate aminotransferase | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Elevated alanine aminotransferase | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Elevated blood alkaline phosphatase | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Herpes virus reactivation | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
This study was terminated early which lead to small number of subjects analyzed. The study did not reach the target number of participants needed to achieve target power and statistically reliable results.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Bradley | Clovis Oncology, Inc. | 1-415-409-5495 | ebradley@clovisoncology.com |
| Oct 26, 2018 |
| Prot_SAP_000.pdf |
| 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 |
|---|---|
| C000589977 | rociletinib |
| C000594389 | atezolizumab |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Counts |
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| Units |
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| Counts |
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