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Association details:
| Biomarker: | EGFR T790M |
|---|---|
| Cancer: | Lung Cancer |
| Drug: | Tagrisso (osimertinib) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Tagrisso (osimertinib) receives full Health Canada approval for targeted treatment of non-small cell lung cancer
Excerpt:
AstraZeneca Canada announces that Health Canada has granted full approval (Notice of Compliance) for Tagrisso (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
Source:
Title:
TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy
Excerpt:
...DCR`PFS`T790M postive rate in Plasma cell free DNA`T790M postive rate in BALF free DNA`T790M postive rate in tissue`Concordance rate of T790M positivity between plasma & BALF`T790M sensitivity & specificity in Plasma & BALF (gold standard: tissue biopsy)`The frequency of occurrence of grade 3 or higher AE/SAEs...
Source:
Title:
Real-world Analysis of Workup at Disease Progression and Implementation of Osimertinib for EGFR+ NSCLC
Excerpt:
...the rate of rebiopsy and molecular workup (especially T790M testing) at disease progression under treatment with first-/second-generation EGFR inhibitors the frequency of T790M mutations in the molecular workup of patients with disease progression under first-/second-generation EGFR inhibitors the actual rate of osimertinib implementation after failure of first-/second-generation EGFR inhibitors in the "real-world" setting.`...
More C2 evidence
Source:
Title:
A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)
Excerpt:
...Confirmation by the local laboratory that the tumour harbours one of the two common EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo EGFR mutation resulting in substitution of threonine with methionine at amino acid position 790 in exon 20 of EGFR (T790M) or uncommon EGFR mutations G719X, S768I, and L861Q, either alone, in combination with each other, or in combination with other uncommon EGFR mutations (excluding all exon 20 insertions) (Uncommon EGFRm Cohort)....
Trial ID:
Source:
Title:
OCEANiC: A Phase II, Open-label, Multi-centre Clinical Trial of Osimertinib With or Without Adjuvant Chemotherapy Guided by Tumour NGS Co-mutation Status and ctDNA Detection in Patients WithnStage IIA-IIIA EGFR-Mutant Non Small Cell Lung Cancer Following Complete Surgical Resection
Excerpt:
...These include exon 19 deletions, L858R (exon 21), G719X (exon 18), L861Q (exon 21), S768I (exon 20) and T790M (exon 20). ...
Trial ID:
Source:
Title:
Combination of Osimertinib and Aspirin to Treat 1st Generation EGFR-TKI Resistance in NSCLC
Excerpt:
...To evaluate the response to therapy and 1 year median progression-free survival（PFS） rates of the combination of Osimertinib and Aspirin in patients who harbors T790M EGFR-mutant with metastatic pulmonary adenocarcinoma disease progression to 1st generation EGFR-TKI .`...
Source:
Title:
AZD9291, an Irreversible EGFR-TKI, in Relapsed EGFR-mutated Non-small Cell Lung Cancer Patients Previously Treated With an EGFR-TKI, Coupled to Extensive Translational Studies
Excerpt:
...Documented EGFR mutation known to be associated with EGFR TKI sensitivity (also including T790M)....
Source:
Title:
T790M Plasma Testing Methodology Comparison and Clinical Validation
Excerpt:
...To evaluate concordance of T790M mutation plasma testing between the Cobas test and Super-ARMS platform.`...
Source:
Title:
Local Ablative Therapy for Treatment of Oligoprogressive, EGFR-Mutated, Non-Small Cell Lung Cancer After Treatment With Osimertinib
Excerpt:
...- Patients with histologically confirmed, by the National Cancer Institute (NCI) Laboratory of Pathology or by Clinical Laboratory Improvement Amendments of 1988 (CLIA)-certified Next Generation Sequencing or Cobas estimated Epidermal Growth Factor Receptor (EGFR) Mutation Test v1/2 at an outside institution, advanced lung adenocarcinoma with EGFR-sensitizing somatic mutations or a germline T790M mutation (detected histologically or via circulating tumor deoxyribonucleic acid (ctDNA) analysis using a CLIA assay) with:...
Trial ID:
Source:
Title:
EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer
Excerpt:
...Group 2: Patient has an EGFR T790M-persistent mutation, having progressed on/after 2nd- or later-line osimertinib or other 3rd-generation EGFR TKI....
Source:
Title:
Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm
Excerpt:
...At least one documented uncommon EGFR mutation of G719X/L861Q/S768I/de novo T790M without EGFR Ex19del/L858R/exon 20 insertion as detected in tumour tissue, through real-time PCR or NGS analysis from accredited laboratories approved by the Chinese regulatory authority....
Trial ID:
Source:
Title:
AZD9291 First Time In Patients Ascending Dose Study
Excerpt:
...- For dose expansion and extension cohorts, patients must also have confirmation of tumour T790M mutation status (confirmed positive or negative) from a biopsy sample taken after disease progression on the most recent treatment regimen (irrespective of whether this is EGFR TKI or chemotherapy)....
Source:
Title:
Intrathecal Pemetrexed for Leptomeningeal Metastasis in EGFR-Mutant NSCLC
Excerpt:
...EGFR activating mutations include exon19 deletion, T790M, L858R, G719X, L861Q, or S768I....
Trial ID:
Source:
Title:
Open-label PET Study With [11C]Osimertinib in Patients With EGFRm NSCLC and Brain Metastases
Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR-TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) or T790M EGFR resistance mutation as assessed by local laboratory/or central laboratory via tissue/cytology or in plasma....
Source:
Title:
AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.
Excerpt:
...Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M....
Source:
Title:
Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)
Excerpt:
...As confirmed by the central laboratory, the tumor contains one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), alone or in conjunction with other EGFR mutations, including T790M; 7....
Source:
Title:
AZD9291 in Combination With Ascending Doses of Novel Therapeutics
Excerpt:
...Local confirmation of tumour T790M status is acceptable if performed with an approved test and agreed by AstraZeneca....
Source:
Title:
A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)
Excerpt:
...The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations known to be associated with Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EGFR) mutations, which may include T790M....
Source:
Title:
Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery
Excerpt:
...- Documented activating EGFR mutation (Exon 19 deletion, T790M, or L858R) on tumor samples by Clinical Laboratory Clinical Laboratory Improvement Amendments (CLIA)-approved test...
Trial ID:
Source:
Title:
Osimertinib, Surgery, and Radiation Therapy in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer With EGFR Mutations, NORTHSTAR Study
Excerpt:
...- NSCLC which harbors an EGFR T790M mutation that was acquired following progression on erlotinib, gefitinib or afatinib....
Trial ID:
Source:
Title:
Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study
Excerpt:
...Ongoing or planned osimertinib treatment according to marketing authorization (first line treatment of tumor positive for a common or uncommon EGFR mutation, or later line treatment of tumor positive for EGFR T790M mutation, assessed according to local standard....
Trial ID:
Source:
Title:
Study of Osimertinib in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation
Excerpt:
...Testing for T790M mutation in circulating tumour DNA or tumour tissue sample at progression on the last treatment received before inclusion....
Trial ID:
Source:
Title:
Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC
Excerpt:
...- A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q)....
Source:
Title:
Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO)
Excerpt:
...- Histologically confirmed, treatment naïve EGFR-mutant NSCLC, with or without T790M resistance mutation....
Trial ID:
Source:
Title:
Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC
Excerpt:
...The tumour harbors at least 1 of the 4 uncommon EGFR mutations (G719X/L861Q/S768I/T790M), either alone or in combination, which...
Trial ID:
Source:
Title:
First Line Osimertinib for EGFR Mutation-positive Non-Small Cell Lung Cancer in Real World Chinese Setting
Excerpt:
...Progression-free survival (PFS) and Progression-free survival rate (PFS rate)`Objective Response Rate (ORR) and Disease Control Rate (DCR)`Overall survival rate (OS rate)`de novo T790M mutation rate`Adverse events/Serious adverse events...
Trial ID:
Source:
Title:
Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations
Excerpt:
...Patients with the T790M mutation will also be eligible....
Trial ID:
Source:
Title:
Neo-adjuvant Trial With AZD9291 in EGFRm+ Stage IIIA/B NSCLC
Excerpt:
...Treatment-naïve stage IIIA/B NSCLC with an activating sensitizing EGFR mutation/T790M • Uncommon sensitizing EGFR mutations are allowed....
Trial ID:
Source:
Title:
Osimertinib for Russian EGFR T790M Mutation-positive NSCLC Patients Who Progressed on or After EGFR TKI Therapy
Excerpt:
...- Confirmed diagnosis of IIIB (locally advanced) or IV (metastatic) stages of NSCLC with T790M EGFRm;...
Source:
Title:
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
Excerpt:
...- Patients with confirmed advanced (locally advanced (stage IIIB) or metastatic (stage IV)) NSCLC with a positive test result for the EGFR T790M mutation...
Trial ID:
Source:
Title:
Osimertinib for Advanced EGFR-positive NSCLC Patients
Excerpt:
...Validated activating EGFR sensitising mutations with or without T790M resistance mutation at the time of recruitment for patients who have...
Trial ID:
Source:
Title:
Study of AZD9291 in NSCLC Patients Harboring T790M Mutation Who Failed EGFR TKI and With Brain and/or LMS
Excerpt:
...- EGFR activating mutant NSCLC patients who failed EGFR TKIs (gefitinib, erlotinib, or afatinib) and develop CNS disease (BM and/or LM) with T790M mutation either tissue or plasma....
Trial ID:
Source:
Title:
Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M
Excerpt:
...- Patients with histological confirmation of locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with an activating EGFR mutation and concomitant T790M mutation who are...
Trial ID:
Source:
Title:
KOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy)
Excerpt:
...Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy...
Trial ID:
Source:
Title:
Resistance & Activating Mutations Diagnosed Among NSCLC Community Dwelling EGFR Mutation Positive Patients
Excerpt:
...The Overall Percent Agreement will be estimated as analytic concordance between Guardant360 plasma and Trovera urine testing versus cobas tissue testing in identifying T790M status (positive or negative). ...
Trial ID:
Source:
Title:
Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC
Excerpt:
...with confirmation of the presence of the T790M mutation 4....
Source:
Title:
Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC
Excerpt:
...- Confirmed T790M mutation...
Trial ID:
Source:
Title:
Intracranial Activity of AZD9291 (TAGRISSO) in Advanced EGFRm NSCLC Patients With Asymptomatic Brain Metastases
Excerpt:
...- Exon 19 deletion, L858R, T790M and uncommon sensitizing EGFR mutations in treatment-naïve patients are allowed....
Source:
Title:
Osimertinib in First and Second Line Treatment of NSCLC Harboring EGFR Mutations From Circulating Tumor DNA
Excerpt:
...T790M mutation detected from circulating tumor DNA either by PANA mutyper® or Cobas® EGFR mutation test....
Source:
Title:
Uncommon EGFR AZD9291
Excerpt:
...- Histologically confirmed metastatic or recurrent stage IV NSCLC with activating EGFR mutation other than deletion in exon 19, L858R, T790M and insertion in exon 20...
Trial ID:
Source:
Title:
Open Label, Prospective Study to Investigate Efficacy and Safety of AZD9291 in BM From NSCLC Patients With EGFR T790M
Excerpt:
...with confirmation of the presence of the T790M mutation....
Source:
Title:
Phase II study of 5 years of adjuvant osimertinib in completely resected EGFRm NSCLC Estudio de fase II de 5 años del tratamiento adyuvante con osimertinib en el cáncer de pulmón no microcítico con mutación del receptor del factor de crecimiento epidérmico completamente resecado.
Excerpt:
...Staging will be according to the pTNM (pathologic tumour,node, metastasis) staging system for lung cancer 8) Confirmation by the local laboratory that the tumour harbours 1 of the following EGFRmutations:-1 of the 2 common EGFR mutations (Ex19del, L858R), either alone or incombination with other EGFR mutations including de novo T790M and excluding allexon 20 insertions (Common EGFRm Cohort); or - Uncommon EGFR mutations G719X, S768I, and L861Q, either alone, in combination with each other, or in combination with other uncommon EGFR mutations (excluding all exon 20 insertions) (Uncommon EGFRm Cohort).9) Complete surgical resection of the primary NSCLC is mandatory. ...
Trial ID:
Source:
Title:
A Clinical Study of Lazertinib with Subcutaneous Amivantamab Administered via Manual Injection Compared with Intravenous Amivantamab or Amivantamab Subcutaneous On Body Delivery System in Patients with EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy Uno studio clinico di lazertinib con amivantamab per via sottocutanea somministrato tramite iniezione manuale rispetto ad amivantamab per via endovenosa o ad amivantamab per via sottocutanea in pazienti con carcinoma polmonare non a piccole cellule avanzato o metastatico con mutazioni di EGFR dopo progressione durante il trattamento con osimertinib e chemioterapia
Excerpt:
...Have progressed on or after osimertinib and platinum-based chemotherapy •Osimertinib must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. ...
Trial ID:
Source:
Title:
Phase 2 trial of alternating osimertinib with gefitinib in patients with EGFR-T790M mutation positive advanced non-small cell lung cancer
Excerpt:
...Documented evidence of EGFR-T790M mutation on tissue and/or plasma sample following disease progression on the most recent EGFR-TKI therapy (T790M mutation status will need to be re-confirmed in the event of an alternative systemic treatment following progression on the most-recent EGFR-TKI therapy)....
Trial ID:
Source:
Title:
The Efficacy and Safety of Osimertinib with Platinum plus Pemetrexed Chemotherapy, as First-Line Treatment in Recurrent or Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients with Uncommon Epidermal Growth Factor Receptor Mutations (EGFRm): A Phase II, Open Label, Single Arm, Multicenter, Exploratory 
Excerpt:
...According to the ARMS or Super-ARMS or NGS test results of tumor tissue or plasma from a certified laboratory approved by Chinese regulatory authorities, the tumor carries at least one of the 4 rare EGFR mutations (G719X/L861Q/S768I/T790M) (single mutation or compound mutation), but not other EGFR mutations (including ex19del/L858R). ...
Trial ID:
Source:
Title:
this trial is finalized to evaluate the tolerability and the quality of life in patients with Lung cancer who take AZD9291 Questa sperimentazione ¿ finalizzata a valutare la tollerabilit¿ e l'impatto sulla qualit¿ della vita dei pazienti affetti da tumore polmonare che assumono AZD9291
Excerpt:
...Patients must have confirmation of tumour T790M mutation positive status from a biopsy sample taken after confirmation of disease progression on treatment with EGFR-TKI. ...
Source:
Title:
An open, multicenter study of the Mechanism of Osimertinib Resistance in Chinese Non-small Cell Lung Cancer (NSCLC)
Excerpt:
...The EGFR must be defined before administration of Osmertinib T790m mutation positive; 5. ...
Trial ID:
Source:
Title:
Radiation during Osimertinib Treatment: a Safety and Efficacy Cohort Study
Excerpt:
...Ongoing or planned osimertinib treatment according to marketing authorization (first line treatment of tumor positive for an activating EGFR mutation, or later line treatment of tumor positive for EGFR T790M mutation, assessed according to local standard. ...
Trial ID:
Source:
Title:
Patients on osimertinib with EGFR mutation exon 20, non-T790M in lung cancer. The position-20 trial.
Excerpt:
...Presence of an EGFR exon 20, non-T790M, mutation, deletions and/or insertion only, 5. ...
Trial ID:
Source:
Title:
A clinical study exploring the effect of osimertinib and radiation therapy, in people with newly diagnosed non-small cell lung cancer (NSCLC) that has spread to a few other parts of the body and shows a change (mutation) in the EGFR gene. Un estudio clínico que explora el efecto del osimertinib y la radioterapia en personas con cáncer de pulmón de células no pequeñas (CPCNP) recién diagnosticado que se ha diseminado a algunas otras partes del cuerpo y muestra un cambio (mutación) en el gen EGFR.
Excerpt:
...1) Histologically confirmed, treatment naïve EGFR-mutant NSCLC, with or without T790M resistance mutation.2) Presence of sensitising EGFR-mutation (exon 19 deletion and/or exon 21 L858R) detected by an accredited laboratory.3) Synchronous oligo-metastatic stage IV disease (max 5 lesions)4) Measurable disease as defined according to RECIST v1.15) All lesions amenable for radical radiotherapy according to local judgment6) ECOG performance status 0-27) Adequate haematological, renal and liver function 1) CPNM con mutación EGFR sin tratamiento, confirmado histológicamente, con o sin mutación de resistencia T790M.2) Presencia de mutación EGFR sensibilizante (deleción del exón 19 y / o exón 21 L858R) detectada por un laboratorio acreditado.3) Enfermedad sincrónica oligo-metastásica en estadio IV (máximo 5 lesiones)4) Enfermedad medible según se define de acuerdo con RECIST v1.15) Todas las lesiones susceptibles de radioterapia radical según el criterio local.6) estado funcional ECOG 0-27) Función hematológica, renal y hepática adecuada`- Histologically confirmed, treatment naïve EGFR-mutant NSCLC, with or without T790M resistance mutation.- Presence of sensitising EGFR-mutation (exon 19 deletion and/or exon 21 L858R) detected by an accredited laboratory.- Synchronous oligo-metastatic stage IV disease (max 5 lesions).- Measurable disease as defined according to RECIST v1.1.- All lesions amenable for radical radiotherapy according to local judgment.- ECOG performance status 0-2.- Adequate haematological, renal and liver function. ...
Trial ID:
Source:
Title:
A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer
Excerpt:
...- A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (eg., T790M, G719X, Exon20 insertions, S7681 and L861Q)....
Less C2 evidence
Source:
Title:
Osimertinib for lung cancer cells harboring low-frequency EGFR T790M mutation
Published date:
05/30/2022
Excerpt:
NGS and allele-specific PCR confirmed the low-allele frequency of EGFR T790M present at 5% with a 100-fold higher resistance to erlotinib in the PC-9R cells and its sub-clones….Consistent with in vitro data, osimertinib, but not erlotinib, caused tumor regression in mice injected with PC-9R cells, while both osimertinib and erlotinib inhibited tumors in mice injected with PC-9 cells...allele-specific PCR confirmed the presence of EGFR T790M mutation in PC-9R cells (Fig. 2C)....In accordance with the in vitro data and literature supporting the higher efficacy of osimertinib, both the PC-9 and PC-9R mice showed remarkable responses to daily osimertinib treatment.
DOI:
https://doi.org/10.1016/j.tranon.2022.101461
