Tagrisso (osimertinib) / AstraZeneca  >>  Phase 3
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34 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Tagrisso (osimertinib) / AstraZeneca
AURA3, NCT02151981 / 2014-000594-39: AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Checkmark AURA3 trial in 2L T790M NSCLC at WCLC 2016
Dec 2016 - Dec 2016: AURA3 trial in 2L T790M NSCLC at WCLC 2016
Checkmark AURA-3 trial in NSCLC
Jul 2016 - Jul 2016: AURA-3 trial in NSCLC
Checkmark Initiation of P3 AURA3 trial for TKI failure and primary resistance mutation T790M advanced EGFRm+ NSCLC
More
Active, not recruiting
3
419
Europe, Canada, Japan, US, RoW
Chemotherapy, Osimertinib, Platinum-based Doublet-Chemotherapy, Cross-over to Osimertinib
AstraZeneca
Anticancer Treatment
04/16
12/23
FLAURA, NCT02296125 / 2014-002694-11: AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Checkmark Data from FLAURA study for NSCLC
Mar 2021 - Mar 2021: Data from FLAURA study for NSCLC
Checkmark From FLAURA trial for 1st-line EGFR + NSCLC
Oct 2018 - Oct 2018: From FLAURA trial for 1st-line EGFR + NSCLC
Checkmark In 1L EGFR mutated NSCLC
More
Active, not recruiting
3
674
Europe, Canada, Japan, US, RoW
AZD9291 80 mg/40 mg + placebo, Placebo Erlotinib 150/100mg, Placebo Tarceva 150/100 mg, Placebo Gefitinib 250 mg, Placebo Iressa 250 mg, Erlotinib 150/100 mg, Tarceva 150/100 mg, Gefitinib 250 mg, Iressa 250mg, Placebo AZD9291 80 mg/ 40 mg
AstraZeneca, Parexel
Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer
06/17
01/25
CAURAL, NCT02454933: Study of AZD9291 Plus MEDI4736 Versus AZD9291 Monotherapy in NSCLC After Previous EGFR TKI Therapy in T790M Mutation Positive Tumours

Checkmark CAURAL trial of durvalumab in combination with osimertinib second-line T790M+ NSCLC
Feb 2019 - Feb 2019: CAURAL trial of durvalumab in combination with osimertinib second-line T790M+ NSCLC
Checkmark Of P3 CAURAL trial of Tagrisso + durvalumab in second-line advanced EGFRm T790M NSCLC due to safety/efficacy reason
Apr 2016 - Apr 2016: Of P3 CAURAL trial of Tagrisso + durvalumab in second-line advanced EGFRm T790M NSCLC due to safety/efficacy reason
Completed
3
29
Canada, RoW
AZD9291, MEDI4736
AstraZeneca
Locally Advanced or Metastatic EGFR T790M+ NSCLC
08/17
06/23
ADELOS, NCT02997501: T790M Plasma Testing Methodology Comparison and Clinical Validation

Completed
3
256
RoW
T790M+ Testing, Baseline Visit Blood & Urine Testing, Baseline ECG, Visual Slit-Lamp Testing, AZD9291 Dosing, Plasma AZD9291 testing
AstraZeneca, TigerMed
Lung Cancer
10/18
10/18
RELAY, NCT02411448 / 2014-004824-22: A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC

Checkmark Presentation of data from RELAY trial in combination with erlotinib in 1L treatment of NSCLC at ESMO 2020
Jul 2020 - Jul 2020: Presentation of data from RELAY trial in combination with erlotinib in 1L treatment of NSCLC at ESMO 2020
Checkmark From RELAY trial in combination with erlotinib for 1L EGFR-mutated NSCLC
Oct 2019 - Oct 2019: From RELAY trial in combination with erlotinib for 1L EGFR-mutated NSCLC
Checkmark From RELAY trial in combination with Tarceva for 1L EGFR NSCLC at ASCO 2019
More
Active, not recruiting
3
545
Europe, Canada, Japan, US, RoW
Ramucirumab, LY3009806, Placebo, Erlotinib, Gefitinib, Osimertinib
Eli Lilly and Company
Metastatic Non-Small Cell Lung Cancer
01/19
12/24
ASTRIS, NCT02474355 / 2015-001407-31: Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC

Completed
3
3017
Europe, Canada, RoW
T790M+ Testing, Baseline Visit Blood & Urine Testing, Baseline ECG, Visual Slit-Lamp Testing, AZD9291 Dosing
AstraZeneca, Parexel
Lung Cancer
04/19
04/19
APOLLO, NCT02972333: Open Label, Prospective Study to Investigate Efficacy and Safety of AZD9291 in BM From NSCLC Patients With EGFR T790M

Unknown status
3
150
NA
AZD9291 80mg oral each day, AZD9291, 80mg, QD, p.o. (2nd line or later), Radiation therapy, WBRT or SRS
Shandong Cancer Hospital and Institute, AstraZeneca
EGFR-TKI Resistant Mutation, Nonsmall Cell Lung Cancer, AZD9291, Brain Metastases
09/19
12/19
ADAURA, NCT02511106 / 2015-000662-65: AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

Checkmark DFS of five and a half years from ADAURA trial for adjuvant treatment of EGFRm NSCLC
Sep 2022 - Sep 2022: DFS of five and a half years from ADAURA trial for adjuvant treatment of EGFRm NSCLC
Checkmark Exploratory and post-hoc analysis data from ADAURA study
Jan 2021 - Jan 2021: Exploratory and post-hoc analysis data from ADAURA study
Checkmark From ADAURA trial in adjuvant EGFRm NSCLC at ESMO 2020
More
Active, not recruiting
3
682
Europe, Canada, Japan, US, RoW
AZD9291 80 mg/40 mg, Placebo AZD9291 80 mg/40 mg, Open-label AZD9291 80 mg/40 mg
AstraZeneca
Stage IB-IIIA Non-small Cell Lung Carcinoma
04/22
01/29
2019-003969-18: A study to evaluate Chemotherapy Plus Osimertinib against Chemotherapy Plus Placebo in patients with non-small cell lung cancer (NSCLC)

Not yet recruiting
3
204
Europe
Osimertinib 80 mg, Osimertinib 40 mg, Cisplatin, Carboplatin, Pemetrexed, AZD9291, Film-coated tablet, Concentrate for solution for infusion, Solution for infusion, Powder for concentrate for solution for infusion, TAGRISSO
AstraZeneca AB, ASTRAZENECA AB, AstraZeneca AB
Non-Small Cell Lung Cancer, EGFRm locally adv or metastatic Non-Small Cell Lung Cancer., Diseases [C] - Cancer [C04]
 
 
2021-001825-33: A Clinical Study of Amivantamab and Lazertinib in Combination with Platinum-Based Chemotherapy Compared with Platinum-Based Chemotherapy in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure

Not yet recruiting
3
690
Europe, RoW
Amivantamab, Lazertinib, JNJ-61186372, JNJ-73841937/YH-25448, Solution for infusion, Tablet
Janssen-Cilag International NV, JANSSEN CILAG INTERNATIONAL NV, Janssen Research and Development, Janssen Cilag SpA
Locally Advanced or Metastatic Non-Small Cell Lung Cancer, A specific type of lung cancer called "Non-Small Cell Lung Cancer", Diseases [C] - Cancer [C04]
 
 
2021-004135-89: 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.

Not yet recruiting
3
380
Europe
Osimertinib 40 mg, Osimertinib 80 mg, AZD9291, Film-coated tablet, Tagrisso
AstraZeneca AB, ASTRAZENECA AB, AstraZenecaAB
Stage IA2-IA3 non-small cell lung carcinoma, with EGFR mutation type (Ex19del, L858R), following complete tumour resection. Estadio IA2-IA3 de cáncer de pulmón no microcítico, positivo para la mutación de EGFR (Ex19del, L858R), tras la resección completa del tumor., Specific type of lung cancer called non-small cell lung cancer (NSCLC) stage IA2-IA3 with EGFR mutations positive after complete surgical removal of a tumour between 1 and 3 centimetres. Tipo específico de cáncer de pulmón no microcítico (CPNM) en estadío IA2-IA3 positivo para mutaciones de EGFR, tras la resección completa del tumor entre 1 y 3 centímetros., Diseases [C] - Cancer [C04]
 
 
2021-006374-24: A clinical trial to compare the effectiveness of savolitinib plus osimertinib versus chemotherapy for the treatment of non-small cell lung cancer Un ensayo clínico para comparar la eficacia de savolitinib más osimertinib frente a la quimioterapia para el tratamiento del cáncer de pulmón no microcítico

Not yet recruiting
3
324
Europe
Savolitinib, osimertinib 80 mg, osimertinib 40 mg, Cisplatin, Carboplatin, Pemetrexed, AZD6094, HMPL-504, AZD9291, Tablet, Film-coated tablet, Concentrate for solution for infusion, TAGRISSO
AstraZeneca AB, ASTRAZENECA AB, AstraZeneca AB
EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Cáncer de pulmón no microcítico localmente avanzado o metastásico con mutación EGFR y MET positivo, Non-Small Cell Lung Cancer Cáncer de pulmón no microcítico, Diseases [C] - Cancer [C04]
 
 
2022-000525-25: 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

Ongoing
3
640
Europe
Amivantamab (JNJ-61186372), Amivantamab (JNJ-61186372) co-formulated with recombinant human hyaluronidase (rHuPH20), Amivantamab JNJ-61186372 co-formulated with recombinant human hyaluronidase (rHuPH20) OBDS, Lazertinib mesylate monohydrate, [JNJ-61186372], [JNJ-73841937-ZCY/YH25448AM], Concentrate for solution for infusion, Concentrate for solution for injection/infusion, Film-coated tablet
JANSSEN CILAG INTERNATIONAL NV, Janssen-Cilag International NV, Janssen Research & Development, LLC
EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer carcinoma polmonare non a piccole cellule avanzato o metastatico con mutazioni di EGFR, A specific type of lung cancer called "Non-Small Cell Lung Cancer" carcinoma polmonare non a piccole cellule, Diseases [C] - Cancer [C04]
 
 
GEOMETRY-E, NCT04816214 / 2020-003677-21: Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy

Terminated
3
6
Japan, RoW
Capmatinib, INC280, Osimertinib, Pemetrexed, Cisplatin, Carboplatin
Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
12/22
12/22
FLAURA2, NCT04035486 / 2019-000650-61: 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

Hourglass Jan 2024 - Mar 2024 : Q1'24 - PDUFA date for FDA approval in adults with locally advanced/metastatic EGFRm NSCLC (based on FLAURA2 trial)
Jan 2022 - Dec 2023: Data from FLAURA2 trial in combination with carboplatin or pemetrexed/cisplatin for 1L EGFRm NSCLC
Active, not recruiting
3
587
Europe, Canada, Japan, US, RoW
Osimertinib, AZD9291, Pemetrexed/Carboplatin, Pemetrexed/Cisplatin
AstraZeneca
Non-Small Cell Lung Cancer
04/23
06/26
MARIPOSA-2, NCT04988295: A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

Active, not recruiting
3
776
Europe, Canada, Japan, US, RoW
Lazertinib, JNJ-73841937, YH-25448, Amivantamab, JNJ-61186372, Pemetrexed, Carboplatin
Janssen Research & Development, LLC
Carcinoma, Non-Small-Cell Lung
07/23
12/25
TREBLE, NCT05493501: Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer

Terminated
3
8
US
Aumolertinib monotherapy, EQ143, HS-10296, Osimertinib monotherapy, Tagrisso, Pemetrexed, Alimta, Cisplatin, Carboplatin, Paclitaxel, Taxol, Nab paclitaxel, Abraxane, Albumin-bound paclitaxel, Gemcitabine, Gemzar
EQRx International, Inc.
NSCLC
08/23
08/23
PALOMA-3, NCT05388669 / 2022-000525-25: A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

Active, not recruiting
3
418
Europe, Canada, Japan, US, RoW
Lazertinib, JNJ-73841937, YH25448, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), JNJ-61186372, Amivantamab Intravenous
Janssen Research & Development, LLC, Janssen Research & Development, LLC
Advanced or Metastatic Non-small Cell Lung Cancer
01/24
01/25
LAURA, NCT03521154 / 2018-001061-16: A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer

Hourglass Jan 2022 - Dec 2023 : From LAURA trial for unresectable EGFRm stage III NSCLC
Hourglass Jan 2022 - Dec 2023 : Acceptance of regulatory submission in US (based on LAURA trial) for unresectable NSCLC
Active, not recruiting
3
216
Europe, Japan, US, RoW
Osimertinib 80mg/40mg, Placebo Osimertinib 80mg/40mg
AstraZeneca
Non Small Cell Lung Cancer (Stage III)
01/24
06/26
NCT06380348: JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations

Not yet recruiting
3
398
NA
JMT101 Injection, Osimertinib tablet, Cisplatin injection, Pemetrexed injection
Shanghai JMT-Bio Inc.
Local Advanced or Metastatic NSCLC
03/27
03/28
TROPION-Lung14, NCT06350097: Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer

Recruiting
3
582
Europe, RoW
Osimertinib, Osimertinib: AZD9291, Datopotamab Deruxtecan: Dato-DXd, Datopotamab Deruxtecan
AstraZeneca, Daiichi Sankyo
Non-small Cell Lung Cancer
03/28
05/32
MARIPOSA, NCT04487080 / 2020-000743-31: A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Calendar Jan 2024 - Dec 2024: From MARIPOSA trial in combination with amivantamab for advanced NSCLC
Active, not recruiting
3
1074
Europe, Canada, Japan, US, RoW
Amivantamab, JNJ-61186372, Osimertinib, Lazertinib, JNJ-73841937 and YH-25448, Placebo
Janssen Research & Development, LLC
Carcinoma, Non-Small-Cell Lung
04/24
06/27
COMPEL, NCT04765059: A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)

Active, not recruiting
3
98
Europe, US, RoW
Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin, Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin
AstraZeneca, Parexel
Non-small Cell Lung Cancer
12/24
12/24
NeoADAURA, NCT04351555 / 2020-000058-89: 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

Hourglass Jan 2022 - Dec 2023 : Data from NeoADAURA trial for EGFRm NSCLC
Recruiting
3
328
Europe, Canada, Japan, US, RoW
Osimertinib, AZD9291; TAGRISSO, Cisplatin, Carboplatin, Placebo, Pemetrexed
AstraZeneca
Non-Small Cell Lung Cancer
07/24
06/29
TROPION Lung15, NCT06417814: A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Not yet recruiting
3
630
NA
Dato-DXd, DS-1062a, Osimertinib, Tagrisso, AZD9291, Pemetrexed, Carboplatin, Cisplatin
AstraZeneca, Daiichi Sankyo
Metastatic Non-small Cell Lung Cancer
09/26
02/28
SACHI, NCT05015608: Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification

Recruiting
3
250
RoW
Savolitinib + Osimertinib, Pemetrexed + Cisplatin /Carboplatin
Hutchison Medipharma Limited
Non-small Cell Lung Cancer
09/24
11/24
SANOVO, NCT05009836: Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC

Recruiting
3
320
RoW
Savolitinib, HMPL-504, Placebo
Hutchison Medipharma Limited
Non-small Cell Lung Cancer
11/24
01/25
ROSY-T, NCT05629234: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO)

Active, not recruiting
3
37
Europe, RoW
Osimertinib, TAGRISSO
AstraZeneca, Parexel
Cancer
02/25
02/25
FLETEO, NCT05382728: Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Recruiting
3
680
RoW
TY-9591, TY-9591 Tablets, placebo Osimertinib, placebo Tagrisso, Osimertinib, Tagrisso, placebo TY-9591, placebo TY-9591 Tablets
TYK Medicines, Inc
NSCLC, EGFR Activating Mutation
05/25
12/27
SAFFRON, NCT05261399: Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

Recruiting
3
324
Europe, Canada, Japan, US, RoW
Savolitinib, AZD6094, HMPL-504, volitinib, Osimertinib, AZD9291, Tagrisso, Pemetrexed, NAP, Cisplatin, Carboplatin
AstraZeneca
Carcinoma, Non-Small-Cell Lung
06/25
12/26
PACIFIC-4, NCT03833154 / 2018-002572-41: Durvalumab vs Placebo With Stereotactic Body Radiation Therapy in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients / Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation

Calendar Jan 2024 - Dec 2024: Data from PACIFIC-4 trial for stage I/II NSCLC
Calendar Jan 2024 - Dec 2024: Acceptance of submission for NSCLC (based on PACIFIC-4 trial)
Recruiting
3
690
Europe, Canada, Japan, US, RoW
Durvalumab, MEDI4736, Placebo, Osimertinib (single-arm, open-label)
AstraZeneca
Carcinoma, Non-Small-Cell Lung
03/26
04/28
ADAURA2, NCT05120349: A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

Recruiting
3
380
Europe, Canada, Japan, US, RoW
Osimertinib, AZD9291; TAGRISSO, Placebo
AstraZeneca
Non-Small Cell Lung Cancer
08/27
11/32
M22-142, NCT06093503: Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein

Withdrawn
3
250
NA
Telisotuzumab Vedotin, ABBV-399, Osimertinib, Cisplatin, Carboplatin, Pemetrexed
AbbVie
Non-Small Cell Lung Cancer
04/28
04/28
NCT05020769: SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer.

Recruiting
2/3
14
RoW
SI-B001, Osimertinib
Sichuan Baili Pharmaceutical Co., Ltd.
Non-small Cell Lung Cancer
08/24
08/24

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