Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002674-93 | EudraCT Number |
Not provided
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The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with aumolertinib.
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Aumolertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets EGFR mutations. The reason for this study is to learn whether adding chemotherapy to a new investigational drug called aumolertinib helps to slow or stop cancer growth in people with EGFR mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC). The study will compare this new combination of drugs to osimertinib, given alone. Aumolertinib given alone will also be used in the study, and it will be looked at in comparison with osimertinib given alone.
This is a randomized, open-label study with 3 different groups that are listed below. "Randomized" means the study treatment participants take will be chosen by chance (decided at random by a computer). "Open-label" means that the participant, the study doctor, and the Sponsor will know which study treatment each participant is receiving.
Participants will be randomly assigned to one of the following 3 treatment groups:
Because there will be twice as many participants in Group 2 and Group 3 as in Group 1, the chance of a participant being randomly assigned to either of those groups is twice as likely as being assigned to Group 1.
Participants can continue to receive study treatment as long as they have not withdrawn consent, as long as they choose to continue to receive study treatment and are judged by their doctor to continue to receive clinical benefit from receiving the study treatment, and as long as no other study treatment and/or study discontinuation criteria are met .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aumolertinib monotherapy | Experimental |
| |
| Aumolertinib + platinum-based doublet chemotherapy | Experimental | For adenocarcinoma, either:
For squamous cell carcinoma, one of the following:
|
|
| Osimertinib monotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aumolertinib monotherapy | Drug | Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from date of randomization until death from any cause. | Up to 6 years |
| Objective Response Rate (ORR) as Assessed by BICR Per RECIST v1.1 | ORR is defined as proportion of participants who achieve a complete response or partial response at any time before progressive disease or initiating a subsequent anticancer therapy. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | 72762 | United States | ||
| Memorial Cancer Institute |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Aumolertinib Monotherapy | Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. |
| FG001 | Aumolertinib + Platinum-based Doublet Chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2023 | Oct 20, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Osimertinib monotherapy | Drug | 80 mg tablet administered orally, once daily |
|
|
| Pemetrexed | Drug | Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy |
|
|
| Cisplatin | Drug | Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. |
|
| Carboplatin | Drug | Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. |
|
| Paclitaxel | Drug | Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. |
|
|
| Nab paclitaxel | Drug | Administered by IV Infusion given over 4 fixed cycles per prescribing information. |
|
|
| Gemcitabine | Drug | Administered by IV Infusion over 4 fixed cycles per prescribing information. |
|
|
| Up to 5 years |
| Disease Control Rate (DCR) as Assessed by BICR Per RECIST v1.1 | DCR is defined as the proportion of participants who have a best overall response of complete response or partial response or stable disease. | Up to 5 years |
| Tumor Growth Rate (TGR) as Assessed by BICR Per RECIST v1.1 | TGR is defined as the constant exponential growth rate estimated using the sum of longest diameters based on radiological tumor assessment per RECIST v1.1. | Up to 5 years |
| Duration of Response (DOR) as Assessed by BICR Per RECIST v1.1 | DOR is defined as date of first response (complete response or partial response) until date of disease progression or death due to any cause, whichever occurs first | Up to 5 years |
| Depth of Response (DepOR) as Assessed by BICR Per RECIST v1.1 | DepOR is defined as the relative change in target lesion tumor size (calculated as the sum of the longest diameters of the target lesions, in the absence of new lesions or progression of nontarget lesions) as compared to baseline. | Up to 5 years |
| PFS as Assessed by the Investigator Per RECIST v1.1 | PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first. | Up to 5 years |
| ORR as Assessed by the Investigator Per RECIST v1.1 | ORR is defined as the proportion of participants who achieve a complete response or partial response at any time before disease progression or initiating a subsequent anticancer therapy. | Up to 5 years |
| DCR as Assessed by the Investigator Per RECIST v1.1 | DCR is defined as the proportion of participants who have a best overall response of complete response or partial response or stable disease. | Up to 5 years |
| TGR as Assessed by the Investigator Per RECIST v1.1 | TGR is defined as the constant exponential growth rate estimated using the sum of longest diameters based on radiological tumor assessment per RECIST v1.1. | Up to 5 years |
| DOR as Assessed by the Investigator Per RECIST v1.1 | DOR is defined as date of first response (complete response or partial response) until the date of disease progression or death due to any cause, whichever occurs first. | Up to 5 years |
| DepOR as Assessed by the Investigator Per RECIST v1.1 | DepOR is defined as the relative change in target lesion tumor size (calculated as the sum of the longest diameters of the target lesions, in the absence of new lesions or progression of nontarget lesions) as compared to baseline. | Up to 5 years |
| Quality of Life as Assessed by the National Cancer Institute Patient Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) Questionnaire | NCI PRO-CTCAE questionnaire responses are scored from 0 to 4, wherein lower values represent a better outcome. For this trial, the burden of symptoms that will be captured by this questionnaire comprises nausea, diarrhea, and rash. | Up to 5 years |
| Rate of Circulating Tumor DNA (ctDNA) Clearance | ctDNA clearance is defined as when a detectable EGFR mutation in ctDNA at baseline becomes undetectable or drops below a predetermined threshold. Rate of ctDNA clearance is defined as 100 × number of participants who are ctDNA-negative at 6 weeks divided by number of participants who are ctDNA-positive at baseline. | 6 weeks |
| Plasma Concentration of Aumolertinib | Plasma concentration is defined as the measured drug concentration of aumolertinib. | Up to approximately 5 months |
| Plasma Concentration of Aumolertinib Metabolite | Plasma concentration is defined as the measured drug concentration of aumolertinib metabolite. | Up to approximately 5 months |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | This outcome will evaluate the incidence of participants with TEAEs, graded according to NCI CTCAE V5. | From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years |
| Number of Participants With Serious Adverse Events (SAEs) | This outcome will evaluate incidence of participants with SAEs, be graded according to NCI CTCAE V5. | From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | This outcome will evaluate incidence of participants with ECG abnormalities | From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years |
| Number of Participants With Laboratory Abnormalities | This outcome will evaluate incidence of participants with laboratory abnormalities, graded according to NCI CTCAE V5. | From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years |
| Hollywood |
| Florida |
| 33021 |
| United States |
| Memorial Cancer Institute | Pembroke Pines | Florida | 33028 | United States |
| QCCA - Mission Blood & Cancer | Des Moines | Iowa | 50314 | United States |
| Summit Health | Florham Park | New Jersey | 07932 | United States |
| SCRI - Tennessee Oncology PLLC- Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| SCRI - Tennessee Oncology- Nashville | Nashville | Tennessee | 37203 | United States |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
For adenocarcinoma, either:
For squamous cell carcinoma, one of the following:
Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.
Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy
Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information.
Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information.
Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.
| FG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
| COMPLETED |
|
| NOT COMPLETED |
|
Study terminated early, no participants completed the study, no participants were analyzed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aumolertinib Monotherapy | Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. |
| BG001 | Aumolertinib + Platinum-based Doublet Chemotherapy | For adenocarcinoma, either:
For squamous cell carcinoma, one of the following:
Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information. |
| BG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
| BG003 | 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 | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first. | data not collected, 0 participants analyzed | Posted | Up to 5 years |
|
| |||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from date of randomization until death from any cause. | data not collected, 0 participants analyzed | Posted | Up to 6 years |
| ||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) as Assessed by BICR Per RECIST v1.1 | ORR is defined as proportion of participants who achieve a complete response or partial response at any time before progressive disease or initiating a subsequent anticancer therapy. | data not collected, 0 participants analyzed | Posted | Up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) as Assessed by BICR Per RECIST v1.1 | DCR is defined as the proportion of participants who have a best overall response of complete response or partial response or stable disease. | data not collected, 0 participants analyzed | Posted | Up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | Tumor Growth Rate (TGR) as Assessed by BICR Per RECIST v1.1 | TGR is defined as the constant exponential growth rate estimated using the sum of longest diameters based on radiological tumor assessment per RECIST v1.1. | data not collected, 0 participants analyzed | Posted | Up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) as Assessed by BICR Per RECIST v1.1 | DOR is defined as date of first response (complete response or partial response) until date of disease progression or death due to any cause, whichever occurs first | data not collected, 0 participants analyzed | Posted | Up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | Depth of Response (DepOR) as Assessed by BICR Per RECIST v1.1 | DepOR is defined as the relative change in target lesion tumor size (calculated as the sum of the longest diameters of the target lesions, in the absence of new lesions or progression of nontarget lesions) as compared to baseline. | data not collected, 0 participants analyzed | Posted | Up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | PFS as Assessed by the Investigator Per RECIST v1.1 | PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first. | data not collected, 0 participants analyzed | Posted | Up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | ORR as Assessed by the Investigator Per RECIST v1.1 | ORR is defined as the proportion of participants who achieve a complete response or partial response at any time before disease progression or initiating a subsequent anticancer therapy. | data not collected, 0 participants analyzed | Posted | Up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | DCR as Assessed by the Investigator Per RECIST v1.1 | DCR is defined as the proportion of participants who have a best overall response of complete response or partial response or stable disease. | data not collected, 0 participants analyzed | Posted | Up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | TGR as Assessed by the Investigator Per RECIST v1.1 | TGR is defined as the constant exponential growth rate estimated using the sum of longest diameters based on radiological tumor assessment per RECIST v1.1. | data not collected, 0 participants analyzed | Posted | Up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | DOR as Assessed by the Investigator Per RECIST v1.1 | DOR is defined as date of first response (complete response or partial response) until the date of disease progression or death due to any cause, whichever occurs first. | data not collected, 0 participants analyzed | Posted | Up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | DepOR as Assessed by the Investigator Per RECIST v1.1 | DepOR is defined as the relative change in target lesion tumor size (calculated as the sum of the longest diameters of the target lesions, in the absence of new lesions or progression of nontarget lesions) as compared to baseline. | data not collected, 0 participants analyzed | Posted | Up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | Quality of Life as Assessed by the National Cancer Institute Patient Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) Questionnaire | NCI PRO-CTCAE questionnaire responses are scored from 0 to 4, wherein lower values represent a better outcome. For this trial, the burden of symptoms that will be captured by this questionnaire comprises nausea, diarrhea, and rash. | data not collected, 0 participants analyzed | Posted | Up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | Rate of Circulating Tumor DNA (ctDNA) Clearance | ctDNA clearance is defined as when a detectable EGFR mutation in ctDNA at baseline becomes undetectable or drops below a predetermined threshold. Rate of ctDNA clearance is defined as 100 × number of participants who are ctDNA-negative at 6 weeks divided by number of participants who are ctDNA-positive at baseline. | data not collected, 0 participants analyzed | Posted | 6 weeks |
| ||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Aumolertinib | Plasma concentration is defined as the measured drug concentration of aumolertinib. | data not collected, 0 participants analyzed | Posted | Up to approximately 5 months |
| ||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Aumolertinib Metabolite | Plasma concentration is defined as the measured drug concentration of aumolertinib metabolite. | data not collected, 0 participants analyzed | Posted | Up to approximately 5 months |
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | This outcome will evaluate the incidence of participants with TEAEs, graded according to NCI CTCAE V5. | data not collected, 0 participants analyzed | Posted | From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | This outcome will evaluate incidence of participants with SAEs, be graded according to NCI CTCAE V5. | data not collected, 0 participants analyzed | Posted | From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities | This outcome will evaluate incidence of participants with ECG abnormalities | data not collected, 0 participants analyzed | Posted | From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years |
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities | This outcome will evaluate incidence of participants with laboratory abnormalities, graded according to NCI CTCAE V5. | data not collected, 0 participants analyzed | Posted | From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years |
|
Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
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 | Aumolertinib Monotherapy | Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Aumolertinib + Platinum-based Doublet Chemotherapy | For adenocarcinoma, either:
For squamous cell carcinoma, one of the following:
Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily | 0 | 5 | 0 | 5 | 5 | 5 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastro-oesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Skin Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Muscular weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pruritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| EQRx Clinical Trials | EQRx International | (650) 779-2300 | clinicalstudies@eqrx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 16, 2022 | Oct 20, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000718108 | aumolertinib |
| C000596361 | osimertinib |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D000418 | Albumins |
| D011506 | Proteins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|
| OG002 | Osimertinib Monotherapy | Osimertinib monotherapy: 80 mg tablet administered orally, once daily |
|