Clinical trials: Osimertinib
Non-small Cell Lung Cancer, EGFR Activating Mutation
Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial
This study is a prospective, single-arm, phase II trial. It is aimed to evaluate the efficacy and safety of the combination of osimertinib and dalpiciclib in patients with EGFR-mutant, CDK4/6 pathway aberrant, advanced NSCLC…
- Conditions
- Non-small Cell Lung Cancer, EGFR Activating Mutation, Cell Cycle Deregulation, EGFR-TKI Resistant Mutation
- Trial name
- NCT06363734
- Testing
- Osimertinib plus Dalpiciclib
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer
AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer
- Trial name
- FLAURA (NCT02296125)
- Testing
- Erlotinib 150/100 mg, Gefitinib 250 mg
- Where
- 170 sites in United States, Australia and 28 more
- Volunteers
- 674 people
- Sponsor
- AstraZeneca
Oncology
A Phase I, Open-label Study to Assess Bioavailability of a Single Oral Dose of AZD9291 vs an IV Dose of [14C]AZD9291
The Sponsor is developing the study drug, AZD9291, for the potential treatment of nonsmall cell lung cancer. Lung cancer has been the most common cancer in the world for several decades and represents 12.8% of all new cancer…
- Trial name
- NCT02491944
- Testing
- AZD9291, [14C]AZD9291
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Carcinoma, Non-Small-Cell Lung
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally…
- Trial name
- SAFFRON (NCT05261399)
- Testing
- Savolitinib, Osimertinib, Pemetrexed
- Where
- 214 sites in United States, Argentina and 25 more
- Volunteers
- 341 people
- Sponsor
- AstraZeneca
Non Small Cell Lung Cancer Metastatic
A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain
The researchers are doing this study is to find out whether treating brain metastasis with SRS after 3 months of therapy with osimertinib is better than treating with osimertinib alone in people with NSCLC.
- Trial name
- NCT06741085
- Testing
- osimertinib, stereotactic radiosurgery (SRS)
- Where
- 8 sites in United States
- Volunteers
- 56 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Non Small Cell Lung Cancer
TAURAS - T790 AURA ScreenFailure SOC Registry Study
The aim of this study is to evaluate clinical outcomes of 2nd line therapy in NSCLC patients without the T790M mutation, both independently and when compared indirectly with NSCLC patients with the T790M mutation in the T STAR…
- Trial name
- TAURAS (NCT02405247)
- Testing
- Patient Reported Outcome (PRO)
- Where
- 5 sites in United States, South Korea
- Volunteers
- 400 people
- Sponsor
- AstraZeneca
Stage II-IIIB Non-small Cell Lung Carcinoma
A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)
To assess the efficacy and safety of osimertinib in participants with EGFRm positive stage II-IIIB NSCLC, following complete tumour resection with or without adjuvant chemotherapy.
- Trial name
- TARGET (NCT05526755)
- Testing
- Osimertinib 80 mg/40 mg
- Where
- 56 sites in United States, Hong Kong and 9 more
- Volunteers
- 188 people
- Sponsor
- AstraZeneca
Lung Neoplasm, Carcinoma, Non-Small-Cell Lung
(HARMONY) Study of BLU-701 in EGFR-mutant NSCLC
This is a Phase 1/2, open-label, first-in-human (FIH) study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of BLU-701 as monotherapy or in combination with either…
- Conditions
- Lung Neoplasm, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Neoplasms
- Trial name
- NCT05153408
- Testing
- BLU-701, osimertinib, carboplatin
- Where
- 7 sites in United States
- Volunteers
- 20 people
- Sponsor
- Blueprint Medicines Corporation
Non-Small Cell Lung Cancer
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
This first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and/or in combination with…
- Trial name
- LuCa-MERIT-1 (NCT05142189)
- Testing
- BNT116, Cemiplimab, Docetaxel
- Where
- 45 sites in United States, Australia and 6 more
- Volunteers
- 320 people
- Sponsor
- BioNTech SE
Nonsmall-cell Lung Cancer
TQ-B3525 Tablets Combined With Osimertinib Mesylate Tablets in the Treatment of Advanced Non-Small Cell Lung Cancer
TQ-B3525 tablet is a new α/δ dual inhibitor phosphatidylinositol 3-kinase inhibitor developed by Chia Tai Tianqing pharmaceutical Group Co., Ltd.
- Trial name
- NCT05284994
- Testing
- TQ-B3525 Tablets, Osimertinib Mesylate Tablets
- Where
- 9 sites in China
- Volunteers
- 160 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Non Small Cell Lung Cancer
Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours
A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor…
- Trial name
- AURA2 (NCT02094261)
- Testing
- AZD9291
- Where
- 44 sites in United States, Canada and 6 more
- Volunteers
- 210 people
- Sponsor
- AstraZeneca
Carcinoma, Non-Small-Cell Lung
Vitamin C and Tyrosine Kinase Inhibitor in Lung Cancer Patients With Epidermal Growth Factor Receptor Mutations
This trial was to explore whether intravenous vitamin C can prolong resistance time of Tyrosine Kinase Inhibitor(TKI) on lung adenocarcinoma patients with Epidermal Growth Factor Receptor(EGFR) mutations, and can benefit NSCLC…
- Trial name
- NCT03799094
- Testing
- Vitamin C, Tyrosine kinase inhibitor
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Clifford Hospital, Guangzhou, China
Non-small Cell Lung Cancer
A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)
This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor…
- Trial name
- NCT03940703
- Testing
- Tepotinib, Osimertinib
- Where
- 179 sites in United States, Belgium and 15 more
- Volunteers
- 140 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Non-Small Cell Lung Cancer
Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)
Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple…
- Trial name
- ORCHARD (NCT03944772)
- Testing
- Osimertinib, Savolitinib, Gefitinib
- Where
- 47 sites in United States, Denmark and 7 more
- Volunteers
- 247 people
- Sponsor
- AstraZeneca
Advanced Non-squamous Non-small-cell Lung Cancer
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC
To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with advanced non-small cell lung cancer (NSCLC).
- Trial name
- HERKULES-2 (NCT04959981)
- Testing
- ERAS-007, ERAS-601, Osimertinib
- Where
- 11 sites in United States
- Volunteers
- 24 people
- Sponsor
- Erasca, Inc.
Local Advanced or Metastatic NSCLC, Harboring EGFR Common Mutation
JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Common Mutations
This was a multicenter, open-label phase 2 study. This study aimed to evaluate the efficacy and safety of JMT101 combined with Osimertinib in participants with local advanced or metastatic non-small-cell lung cancer harbouring…
- Trial name
- NCT06391944
- Testing
- JMT101 Injection, Osimertinib tablet
- Where
- China
- Volunteers
- 161 people
- Sponsor
- Shanghai JMT-Bio Inc.
Anticancer Treatment
AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal…
- Trial name
- AURA3 (NCT02151981)
- Testing
- Chemotherapy, Cross-over to Osimertinib
- Where
- 150 sites in United States, Australia and 16 more
- Volunteers
- 421 people
- Sponsor
- AstraZeneca
Non Small Cell Lung Cancer
PDX Models From EGFR Mutant Tumors
A biospecimen collection study from individuals with EGFR mutant cancers resistant to EGFR TKIs or those harboring an Exon 20 insertion mutation.
- Trial name
- NCT03872440
- Where
- United States
- Sponsor
- Addario Lung Cancer Medical Institute
Non Small Cell Lung Cancer
Study to Assess the Effect of Osimertinib (TAGRISSO™ ) on Blood Levels of Fexofenadine in Patients With EGFRm+ NSCLC
This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior…
- Trial name
- NCT02908750
- Testing
- Fexofenadine tablet dosing, Osimertininb tablet dosing
- Where
- 7 sites in France, South Korea and 1 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Non-Small Cell Lung Cancer With EGFR Mutation
A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC
This study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients…
- Trial name
- NCT06306456
- Testing
- GH21, Tagrisso
- Where
- 6 sites in China
- Volunteers
- 94 people
- Sponsor
- Suzhou Genhouse Bio Co., Ltd.