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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Lung Cancer |
| Drug: | Tagrisso (osimertinib) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Tagrisso approved in Japan for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
Excerpt:
AstraZeneca’s Tagrisso (osimertinib) has been approved in Japan for the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after surgery.
Source:
Title:
A Study of Osimertinib with or without Chemotherapy versus Chemotherapy alone as neoadjuvant therapy for Patients with Epidermal Growth Factor Receptor mutation positive resectable Non-Small Cell Lung Cancer
Excerpt:
...For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.- Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease (according to Version 8 of the IASLC Cancer Staging Manual [IASLC Staging Manual in Thoracic Oncology 2016]).- Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a Mulit-disciplinary Team (MDT) evaluation (which should include a thoracic surgeon, specialised in oncologic procedures).- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.- 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).`...
Trial ID:
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)....
More C2 evidence
Source:
Title:
Phase I, Study in Chinese NSCLC Patients
Excerpt:
...- Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) 6....
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:
OSIREAL - Osimertinib RWE on EGFRm NSCLC in Spain
Excerpt:
...To describe the effectiveness of osimertinib monotherapy in patients with locally advanced or metastatic EGFRm NSCLC (Cohort 1) who have uncommon EGFR mutations.`...
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:
Combination of Osimertinib and Aspirin to Treat EGFR Mutation NSCLC Patients
Excerpt:
...- Patients must have Histologically or cytologically confirmed non small cell carcinoma of the lung who harbors EGFR-mutation and are previously disease progression to 3st generation EGFR-TKI Osimertinib....
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:
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 histologically or cytologically confirmed, advanced or metastatic NSCLC, characterized by either EGFR Exon 19del or Exon 21 L858R mutation by an FDA-approved or other validated test of either ctDNA or tumor tissue in a CLIA certified laboratory or an accredited local laboratory. ...
Trial ID:
Source:
Title:
PET/CT imaging detect EGFR protein mutations of lung cancer with specific molecular probe 11C-AZD9291
Excerpt:
...EGFR mutation status was confirmed by ARMS fluorescence PCR, including 4 cases of 19del mutant, 4 cases of 21L858R mutant, and 2 cases of wild type; 3. ...
Trial ID:
Source:
Title:
Combination of Osimertinib and Aspirin to Treat 1st Generation EGFR-TKI Resistance in NSCLC
Excerpt:
...- Patients must have Histologically or cytologically confirmed non small cell carcinoma of the lung who harbors EGFR-mutation and are previously disease progression to 1st generation EGFR-TKI....
Source:
Title:
Combination of Osimertinib and Aspirin to Treat Osimertinib Resistance Non-small Cell Lung Cancer ( NSCLC)
Excerpt:
...•Patients must have Histologically or cytologically confirmed non small cell carcinoma of the lung who harbors EGFR-mutation and are previously disease progression to 3st generation EGFR-TKI Osimertinib....
Source:
Title:
MEchanisms of resitance in EGFR mutated nonpretreated advanced Lung cancer Receiving OSimErtib Mécanismes de résistance chez des patients avec un cancer du poumon avancé non prétraité, EGFR muté, recevant un traitement par OSIMERTINIB
Excerpt:
...• The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19 deletions, L858R), either alone or in combination with other EGFR mutations. ...
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)....
Source:
Title:
Study to osimertinib treatment in patients with lung cancer. Onderzoek naar de behandeling met osimertinib bij patiënten met longkanker.
Excerpt:
...Patients with EGFR-mutated NSCLC receiving standard treatment with osimertinib for at least 2 months, without any signs of disease progression. ...
Trial ID:
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:
A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients
Excerpt:
...Confirmed EGFR mutation positive before start use prior EGFR TKI(s) ....
Source:
Title:
Real-world Analysis of Workup at Disease Progression and Implementation of Osimertinib for EGFR+ NSCLC
Excerpt:
...- activating EGFR mutation confirmed...
Source:
Title:
Study to Assess the Effect of AZD9291 on the Blood Levels of Rosuvastatin, in Patients With EGFRm+ Non-small Cell Lung Cancer
Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)....
Source:
Title:
TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy
Excerpt:
...Patients with EGFR sensitizing mutation (E19Del, L858R, L861Q, G719X) positive, who had shown clinical benefits (responders (CR or PR) and SD ≥6 months) from EGFR-TKIs and had developed progressive disease following those therapy...
Source:
Title:
Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva)
Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)....
Source:
Title:
T790M Plasma Testing Methodology Comparison and Clinical Validation
Excerpt:
...Concordance of T790M mutation plasma testing between Cobas test and Super-ARMS platform`To assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR- TKI therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS.`...
Source:
Title:
Osimertinib as First-line Therapy for Patients With Late-stage Lung Cancer
Excerpt:
...Patients with EGFR mutation(any form of EGFR mutation subtype except for EGFR exon 20 insertion mutation) detected by First generation sequencing(Sager sequencing) or next generation sequencing(NGS) from tissue sample includes fresh tissue or formalin-fixed paraffin-embedded(FFPE)sample or body fluid sample(blood, pleural effusion, cerebrospinal fluid ,etc.) 3....
Source:
Title:
Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC
Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)....
Source:
Title:
Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)
Excerpt:
...Histologically or cytologically confirmed adenocarcinoma of the lung (patients with mixed histology are eligible if adenocarcinoma is the predominant histology) harboring EGFR mutation(s) known to be associated with EGFR TKI sensitivity at diagnosis....
Source:
Title:
EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer
Excerpt:
...Patients with histologically or cytologically confirmed advanced/metastatic EGFR-mutant NSCLC 5....
Source:
Title:
Intrathecal Pemetrexed for Leptomeningeal Metastasis in EGFR-Mutant NSCLC
Excerpt:
...- Patients with metastatic NSCLC harboring known EGFR activating mutation and with a diagnosis of probable or confirmed LM by the European Association of Neuro-Oncology-European Society for Medical Oncology (EANO-ESMO) guideline....
Trial ID:
Source:
Title:
Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC
Excerpt:
...- Advanced EGFR exon 19 or 21 mutant NSCLC,...
Trial ID:
Source:
Title:
AZD9291 First Time In Patients Ascending Dose Study
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...
Source:
Title:
Osimertinib In EGFR Mutant Lung Cancer
Excerpt:
...- Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory from tumor tissue....
Trial ID:
Source:
Title:
Osimertinib in Treating Patients With Stage IIIB-IV or Recurrent Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
Excerpt:
...- An EGFR exon 20 insertion mutation must be detected in the tumor tissue; patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any Clinical Laboratory Improvement Act (CLIA)-certified tissue assay -...
Trial ID:
Source:
Title:
A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
Excerpt:
...Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation....
Trial ID:
Source:
Title:
Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
Excerpt:
...- Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory....
Trial ID:
Source:
Title:
Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer
Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)....
Source:
Title:
Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma
Excerpt:
...The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion....
Trial ID:
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:
Real-World Study on Gene Profile in Patients With Advanced NSCLC Who Progressed on First-Line Osimertinib Therapy(GPS).
Excerpt:
...Pathologically confirmed non-small cell lung cancer (NSCLC) with documented EGFR sensitive mutation (EGFR 19del and L858R) positive before Osimertinib 1L....
Trial ID:
Source:
Title:
Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
Excerpt:
...- Somatic activating mutation in EGFR in pre-treatment tumor biopsy/ cytology from pleural fluid or cfDNA...
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:
A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations
Excerpt:
...To assess the safety and tolerability of osimertinib plus amivantamab in participants with EGFR mutation-positive, locally advanced, or metastatic NSCLC.`...
Trial ID:
Source:
Title:
Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations
Excerpt:
...- Patients with activating EGFR mutation-positive,...
Trial ID:
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:
A Multicountry, Multicentre, Non-interventional, Retrospective Study to Determine Real-world Treatment Patterns and Associated Outcomes After First Line Osimertinib in Patients With Advanced and Metastatic NSCLC EGFRm in the GCC Region
Excerpt:
...Patients with Stage IIIB-IV NSCLC using either AJCC 7th or 8th edition with EGFR mutation....
Trial ID:
Source:
Title:
Osimertinib With Stereotactic Radiosurgery (SRS) in Brain Metastases From EGFR Positive NSCLC
Excerpt:
...- Confirmed pathology of EGFR mutation positive NSCLC with new brain metastases....
Trial ID:
Source:
Title:
A Prospective Cohort Study to Evaluate Molecular pRognostic Factors and Resistance Mechanisms to Osimertinib in Adjuvant Treatment of Completely Resected pIB-IIIA Non-small Cell Lung Carcinoma With Common EGFR Mutations (L858R and Del19)
Excerpt:
...Presence of a common EGFR mutation (Del19 or L858R)....
Trial ID:
Source:
Title:
AZD9291 in Combination With Ascending Doses of Novel Therapeutics
Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including exon 19 deletion and L858R)....
Source:
Title:
MEchanisms of Resistance in EGFR Mutated Nonpretreated Advanced Lung Cancer Receiving OSimErtib
Excerpt:
...The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19 deletions, L858R), either alone or in combination with other EGFR mutations....
Trial ID:
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:
A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers
Excerpt:
...- Somatic activating mutation in EGFR in pre-treatment tumor biopsy or cfDNA...
Trial ID:
Source:
Title:
AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Excerpt:
...The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)....
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 EGFR exon 19 deletion or L858R mutation....
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:
Study to Assess the Effect of Osimertinib (TAGRISSO™ ) on Blood Levels of Fexofenadine in Patients With EGFRm+ NSCLC
Excerpt:
...- Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR-TKI sensitivity...
Source:
Title:
Study of Osimertinib in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation
Excerpt:
...For cohort 1, the diagnosis of leptomeningeal metastasis requires either 1) detection of cancer cell or EGFR mutation in the CSF, or 2) presence of both clinical and neuro-imaging findings typical of LM, according to EANO-ESMO criteria....
Trial ID:
Source:
Title:
Osimertinib for NSCLC With Uncommon EGFR Mutations
Excerpt:
...Uncommon mutation of EGFR (exon 20 insertion excluded) 5....
Trial ID:
Source:
Title:
Real-world Analysis of Workup at Disease Progression and Implementation of Osimertinib for EGFR+ NSCLC
Excerpt:
...- activating EGFR mutation confirmed...
Trial ID:
Source:
Title:
Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
Excerpt:
...Positive EGFR mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal fluid, etc.); 6....
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:
A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib
Excerpt:
...Patients with an EGFR deletion or mutation known (from tumour biopsy or plasma) to be associated with EGFR TKI sensitivity 6....
Trial ID:
Source:
Title:
A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations
Excerpt:
...- EGFR mutations as performed on a CLIA certified laboratory demonstrating EGFR exon 18 G719X, exon 20 S768I, or exon 21 L861Q....
Trial ID:
Source:
Title:
TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases
Excerpt:
......
Trial ID:
Source:
Title:
Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer With Osimertinib Third-line Rechallenge
Excerpt:
...- Patients must have a known activating Epidermal Growth Factor Receptor (EGFR) mutation....
Trial ID:
Source:
Title:
Osimertinib Resistance in Patients With Non-small-cell Lung Carcinoma That Have Progressed.
Excerpt:
...- Histologically confirmed metastatic NSCLC, characterized by a sensitizing EGFR mutation....
Trial ID:
Source:
Title:
Osimertinib Combined With Aspirin Neoadjuvant Therapy for Resectable EGFR Mutated NSCLC Patients.
Excerpt:
...Patients with EGFR sensitizing mutations (Ex19del or L858R)....
Trial ID:
Source:
Title:
Study to Evaluate SBRT for EGFR Mutant NSCLC Patients Receiving Osimertinib (CULTRO)
Excerpt:
...- Have histological confirmation compatible with EGFR mutant non-small cell lung cancer (NSCLC) and metastatic disease (with or without histological confirmation of metastatic lesions)....
Trial ID:
Source:
Title:
First Line Osimertinib in the Real World: an Inter-regional Prospective Study
Excerpt:
...- histological confirmed diagnosis of NSCLC and EGFR mutation in exon 18-21;...
Source:
Title:
A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)
Excerpt:
...The tumor harbours one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations, assessed by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test in a CLIA certified (USA sites) or an accredited local laboratory (sites outside of the USA) or by central testing (cobas® v2 only)....
Source:
Title:
Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)
Excerpt:
...The resected lung adenocarcinoma should have actionable EGFR mutation, which is limited to L858R or exon 19 deletion....
Trial ID:
Source:
Title:
LAT for Oligoprogressive NSCLC Treated With First-line OSImertinib
Excerpt:
...with an EGFR actionable mutation receiving first-line targeted TKI therapy with osimertinib 3....
Trial ID:
Source:
Title:
Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via ddPCR in NSCLC
Excerpt:
...- histologically/cytologically confirmed stage IV NSCLC patients harboring sensitizing EGFR mutations;...
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:
Efficacy Study of Osimertinib in Treatment-naïve Patients With EGFR Mutant NSCLC According to TP53 Mutational Status.
Excerpt:
...- Locally advanced or metastatic EGFR mutant NSCLC,...
Trial ID:
Source:
Title:
First Line Osimertinib for EGFR Mutation-positive Non-Small Cell Lung Cancer in Real World Chinese Setting
Excerpt:
...- With confirmation of the presence of the EGFR mutation....
Trial ID:
Source:
Title:
Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer
Excerpt:
...- Treatment-naïve for locally advanced/metastatic EGFR-mutated NSCLC and osimertinib treatment-naïve for NSCLC....
Trial ID:
Source:
Title:
SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC
Excerpt:
...Patients receiving first-line Osimertinib for EGFR mutant-positive for 3 months and achieved stable disease or partial response....
Trial ID:
Source:
Title:
Pharmacokinetic Boosting of Osimertinib
Excerpt:
...- Patients with EGFR-mutated NSCLC receiving standard treatment with osimertinib for at least 2 months (steady state), without any signs of disease progression, or during treatment beyond progression, if treatment continuation is expected for multiple months....
Trial ID:
Source:
Title:
First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer
Excerpt:
...Documented EGFR mutation in exon 18-21, except insertions in exon 20, based on tissue analysis....
Trial ID:
Source:
Title:
Osimertinib Plus Chemotherapy vs Osimertinib in EGFRm NSCLC With Persistence Week-3 ctDNA EGFRm After 1L Osimertinib
Excerpt:
...- Newly diagnosed, and histologically documented metastatic non-squamous NSCLC with sensitizing EGFR mutations positive, and classified as stage IV or recurrent NSCLC which are...
Trial ID:
Source:
Title:
Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations
Excerpt:
...- Patients must have adequate archival material from a previous biopsy to determine EGFR mutation status and Cripto-1 expression, or undergo a biopsy of fresh tissue of the primary cancer or a metastatic site in order to make these determinations, if archival material is...
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:
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:
A Window of Opportunity Study for Investigating Drug Tolerant Persister (DTP) to Neoadjuvant Osimertinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harbouring EGFR Mutations
Excerpt:
...Documented activating EGFR mutation (Exon 19 deletion or L858R) 5....
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:
Neurocognition in NSCLC Patients Treated With Osimertinib or Osimertinib + WBI
Excerpt:
...Histologically documented that with sensitizing EGFR mutations(either L858R or Exon19del) 7....
Trial ID:
Source:
Title:
Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC
Excerpt:
...- Epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations)...
Trial ID:
Source:
Title:
Phase III Study Comparing Osimertinib Monotherapy to Combination Therapy With Osimertinib,Carboplatin and Pemetrexed for Untreated Patients With Advanced Non-squamous Non-Small Cell Lung Cancer With Concurrent EGFR and TP53 Mutations
Excerpt:
...Histologically or cytologically confirmed stage IV or recurrent non-squamous non-small cell lung carcinoma with activating EGFR mutations (exon 19 deletion or exon 21 L858R point mutation) and concurrent TP53 mutations; 6....
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:
Intracranial Activity of AZD9291 (TAGRISSO) in Advanced EGFRm NSCLC Patients With Asymptomatic Brain Metastases
Excerpt:
...Group A: treatment-naïve advanced NSCLC with an sensitizing EGFR mutation....
Source:
Title:
Liquid Biopsy as a Tool to Evaluate Resistance to First and Third (AZD9291) (EGFR) (TKIs) in (EGFR) Mutant NSCLC
Excerpt:
...Presence of EGFR activating mutations (exon 19 deletion or L858R in exon 21) 6....
Trial ID:
Source:
Title:
Osimertinib in First and Second Line Treatment of NSCLC Harboring EGFR Mutations From Circulating Tumor DNA
Excerpt:
...Activating EGFR mutation (G719X, exon 19 deletion, L858R, L861Q) detected from circulating tumor DNA either by PANA mutyper® or Cobas® EGFR mutation test....
Source:
Title:
Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC
Excerpt:
...PFS`T790M mutation testing time`Treatment patterns`Adverse events`Adverse event intensity`T790M mutation testing sample`T790M mutation testing platform`EGFR testing mutation subtype...
Trial ID:
Source:
Title:
Study to Assess the Effect of Rifampicin on Blood Levels and Safety of AZD9291, in Patients With EGFRm+ NSCLC
Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)....
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:
A multicenter, open-label, single arm pilot study: Osimertinib as neoadjuvant treatment for resectable stage II-IIIB EGFR mutant lung adenocarcinoma (NEOS)
Excerpt:
...Tested and confirmed to be EGFR mutation-positive (including exon 19 deletion and exon 21 L858R); 6. ...
Trial ID:
Source:
Title:
AZD9291 US Expanded Access Program
Excerpt:
...- Locally advanced or metastatic EGFRm NSCLC,...
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 randomized, open-label, multicenter, phase III study of osimertinib plus chemotherapy versus osimertinib monotherapy in EGFR active mutant NSCLC with concomitant mutation
Excerpt:
...NGS detection (targeting 150 genes) before treatment using tumor tissues indicating EGFR mutation (exon 19 deletion, or exon 21 L858R) and other concurrent mutations (TP53, Rb1, PTEN, Met, ERBB2, KRAS, BRAF, RET or ROS1); 8. ...
Trial ID:
Source:
Title:
The application of osimertinib in early stage combined with stereotactic radiotherapy in EGFR-mutant stage IV oligo-residual non-small cell lung cancer
Excerpt:
...Metastatic NSCLC with positive EGFR sensitive mutation; 4. ...
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 fulfil one of the following:• Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)• OR• Must have experienced clinical benefit from EGFR-TKI, according to the Jackman criteri (Jackman et al 2010) followed by systemic objective progression (RECIST or WHO) while on continuous treatment with EGFR TKI7. ...
Source:
Title:
Adjuvant osimertinib guided by ctDNA-assessed MRD in early-stage EGFR-positive non-small cell lung cancer
Excerpt:
...Patients with stage Ia-IIa non-small cell lung cancer who received complete surgical radical resection with negative margins (R0) and complete lymph node dissection with EGFR mutations (except those reported in the literature that are associated with osimertinib resistance); EGFR mutations, such as L718Q, C797S, etc.); 4. ...
Trial ID:
Source:
Title:
A late stage clinical trial to investigate the efficacy and safety of Osimertinib versus Placebo in patients with stage IA2-IA3 non-small cell lung cancer, following complete tumour resection. Ensayo clínico para investigar la eficacia y seguridad de Osimertinib versus Placebo en pacientes en estadío IA2-IA3 de cáncer de pulmón no microcítico, tras la resección completa del tumor.
Excerpt:
...Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation.8. ...
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:
...Documented evidence of EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be sensitive to osimertinib. ...
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:
First-line Osimertinib plus Consolidation Radiotherapy compared with Osimertinib alone in oligometastatic NSCLC EGFR mutated patients: the randomized phase II OCRa trial GOIRC-06-2019 Studio randomizzato di fase II di confronto tra Osimertinib in associazione alla radioterapia di consolidamento e Osimertinib da solo in pazienti con tumore polmonare non a piccole cellule (NSCLC) in stadio oligometastatico e con mutazione a carico di EGFR: studio OCRa- GOIRC-06-2019
Excerpt:
...Previously untreated advanced EGFR-mutated NSCLC patient, candidate to receive osimertinib as first-line treatment2. ...
Trial ID:
Source:
Title:
Efficacy of microwave ablation combined with oxitinib in the treatment of EGFR + advanced non-small cell lung cancer
Excerpt:
...NSCLC with positive epidermal growth factor receptor (EGFR) gene mutation; 3. ...
Trial ID:
Source:
Title:
Efficacy study of osimertinib in treatment-naïve patients with EGFR mutant NSCLC according to TP53 mutational status (TEMPLE-2) Studio sull’efficacia di Osimertinib in prima linea nei pazienti con NSCLC EGFR mutati sulla base dello stato mutazionale di TP53 (TEMPLE-2)
Excerpt:
...o Provision of informed consent prior to any study specific procedures.o Patients (male/female) must be > 18 years of age.o Locally advanced or metastatic EGFR mutant NSCLC, not amenable to curative surgery or radiotherapy with confirmation of the presence of EGFR exon 19 deletion or exon 21 p.L858R.o Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow central analysis.o Patients must be treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with osimertinib. ...
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:
Less C2 evidence
Source:
Title:
Clinical and genomic landscape of EGFR-mutant lung cancers (LCs) with squamous and adenosquamous differentiation.
Published date:
05/25/2023
Excerpt:
CONTRADICTING EVIDENCE: Pts with EGFR+ sq/adenosq LCs exhibit inferior TTD and OS with 1L osimertinib compared to adenocarcinoma controls.
DOI:
10.1200/JCO.2023.41.16_suppl.9129
Test:
Source:
Title:
Molecular biomarkers of disease outcomes and mechanisms of acquired resistance to first-line osimertinib in advanced EGFR-mutant lung cancers
Published date:
12/05/2022
Excerpt:
CONTRADICTING EVIDENCE: Using multivariate analysis, baseline atypical EGFR (mPFS 5.8 mo, p<0.001) and concurrent TP53/RB1 alterations (mPFS 10.5 mo, p=0.015) were associated with shorter progression-free survival on first-line osimertinib.
DOI:
https://doi.org/10.1016/j.jtho.2022.11.022
Source:
Title:
P76.09 - A Comparison of Sequential EGFR-TKI Therapy Versus First-Line Osimertinib in NSCLC: A Multi-Center, Retrospective Study
Published date:
01/12/2021
Excerpt:
…to assess the outcomes of EGFR mutated lung cancer patients being treated with a first or second generation EGFR TKI compared to osimertinib...The PFS rates at 12 and 18 months were 79.5% and 69.8% in the osimertinib group and 64.2% and 39.3% in the other EGFR TKI groups, respectively (p<0.0036)...osimertinib demonstrated a greater PFS compared to other EGFR TKIs at 12 and 18 months. Estimated OS were no different between the two groups.
Source:
Title:
Challenges in the Management of Lung Cancer: Real-World Experience from a Tertiary Center in South India
Published date:
12/20/2021
Excerpt:
We report the real-world experience in treating patients with lung cancer in India....Of the 58 patients who tested positive for EGFR mutation, 41 (71%) started on EGFR TKI (38 gefitinib, 2 erlotinib, and one osimertinib)….Among those treated with first-line EGFR TKIs, the median PFS was 8.5 months (95% CI, 5.6–11.4) and the median OS was 18.4 months (95% CI, 12.2–24.6).
DOI:
https://doi.org/10.1055/s-0041-1733312
