Study of Osimertinib in Patients with a Lung Cancer with Brain or Leptomeningeal Metastases with EGFR Mutation
NCT ID: NCT04233021
Last Updated: 2025-02-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
57 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-07-16
Study Completion Date
2024-12-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Treatment of non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation is mainly based on tyrosine kinase inhibitors (TKIs) targeting EGFR. 1st or 2nd generation inhibitors have been shown to be superior to chemotherapy in terms of Progression-Free Survival (PFS) when used as 1st line treatment.
In case of progression at several metastatic sites, systemic treatment will be considered and will depend on the presence of the TKI resistance mutation, the T790M mutation. In the presence of the T790M mutation, osimertinib is superior to chemotherapy in terms of progression-free survival, while in the absence of the T790M mutation, platinum salt chemotherapy is recommended. In case of local progression, treatment of the site in progression by radiotherapy and/or surgery is considered. As these local treatments can cause long-term adverse effects, systemic treatments are increasingly being considered in this indication.
Brain and leptomeningeal metastases are the most frequent isolated site of progression in EGFR mutated patients treated with TKI. The high frequency of isolated cerebral and leptomeningeal progression is a consequence of the lower diffusion of 1st and 2nd generation TKIs in the central nervous system (CNS). Osimertinib is a 3rd generation TKI that has the particularity of overcoming the T790M mutation and having greater brain penetration than 1st or 2nd generation TKIs, which could make it an attractive therapeutic option in the event of brain progression or leptomeningeal progression. However, its efficacy in patients with cerebral or leptomeningeal metastases is still poorly understood.
In case of progression at several metastatic sites, systemic treatment will be considered and will depend on the presence of the TKI resistance mutation, the T790M mutation. In the presence of the T790M mutation, osimertinib is superior to chemotherapy in terms of progression-free survival, while in the absence of the T790M mutation, platinum salt chemotherapy is recommended. In case of local progression, treatment of the site in progression by radiotherapy and/or surgery is considered. As these local treatments can cause long-term adverse effects, systemic treatments are increasingly being considered in this indication.
Brain and leptomeningeal metastases are the most frequent isolated site of progression in EGFR mutated patients treated with TKI. The high frequency of isolated cerebral and leptomeningeal progression is a consequence of the lower diffusion of 1st and 2nd generation TKIs in the central nervous system (CNS). Osimertinib is a 3rd generation TKI that has the particularity of overcoming the T790M mutation and having greater brain penetration than 1st or 2nd generation TKIs, which could make it an attractive therapeutic option in the event of brain progression or leptomeningeal progression. However, its efficacy in patients with cerebral or leptomeningeal metastases is still poorly understood.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib
NCT03239340
EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
COMPLETED
PHASE2
Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations
NCT05103605
Non Small Cell Lung Cancer
ACTIVE_NOT_RECRUITING
Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
NCT04410796
Metastatic Non-small Cell Lung Cancer
RECRUITING
PHASE2
Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
NCT03122717
Non-Small Cell Lung Cancer
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
Osimertinib In EGFR Mutant Lung Cancer
NCT03586453
Carcinoma, Non-Small-Cell Lung
RECRUITING
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Non Small Cell Lung Cancer Metastatic
Leptomeningeal Metastasis
Brain Metastases
EGFR Activating Mutation
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Osimertinib
Osimertinib 80 mg/d
Group Type
EXPERIMENTAL
Osimertinib
Intervention Type
DRUG
Osimertinib 80 mg/d
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Osimertinib
Osimertinib 80 mg/d
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Patient with NSCLC (histological or cytological diagnosis) stage IV (8th UICC TNM edition, 2017).
2. Patients with brain and/or leptomeningeal metastases. 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.
3. Presence of an activating EGFR mutation. The following mutations are considered to be activating: L858R, exon 19 deletions, exon 19 insertions, L861Q, G719X. The inclusion of patients with other mutations should be discussed on a case-by-case basis with IFCT.
The presence of co-mutations on an oncogenic driver should be discussed with the IFCT before inclusion of the patient.
4. Testing for T790M mutation in circulating tumour DNA or tumour tissue sample at progression on the last treatment received before inclusion.
5. Maximum lines of anti-cancer treatment received before inclusion:
* For Cohort 1, patients could have been previously treated with maximum 3 lines of anti-cancer treatment.
* For cohort 2, patients could have been previously treated with maximum 1 line of anti-cancer treatment.
In case of previous chemotherapy, a wash-out period of 28 days will be applied. If there was any prior therapy with an investigational agent, a washout period of five half-lives of the compound or 3 months, whichever is greater, is needed.
6. Patient having recovered from all grade ≤ 1 toxicities related to previous anticancer therapies (CTCAE v 5.0) except for alopecia, platinum-therapy-related neuropathy (where ≤2 is allowed).
8\. Presence of at least one evaluable lesion not previously irradiated according to RECIST 1.1. For cohort 2, presence of one CNS evaluable lesion not previously irradiated according to RECIST 1.1.The radiological assessment has to be done within the timelines indicated.
9\. Age of at least 18 years old. 10. Performance status (PS) 0 to 2 (ECOG) except for patients with leptomeningeal carcinomatosis (cohort 1) a PS 3 is authorised.
11\. Patient with a life expectancy of ≥ 6 weeks for cohort 1 and ≥ 12 weeks for cohort 2.
12\. Haematological function:
* Absolute number of neutrophils ≥ 1.5 x 109/L;
* Platelets ≥ 100 x 109/L;
* Haemoglobin ≥ 9 g/dL (transfusions to maintain or exceed this value are accepted).
13\. Hepatic function:
* Total bilirubin ≤ 1.5 x UNL (Upper Normal Limit) or ≤ 3 x UNL in case of documented Gilbert's syndrome or liver metastases;
* AST / ALT \< 2.5 x UNL if no liver metastases or \< 5 x UNL in case of liver metastases.
14\. Renal function: Creatinine ≤1.5 x UNL. If creatinine \> 1.5 x UNL, Creatinine clearance must be ≥ 50 mL/min (Cockroft or MDRD or CKD-epi) 15. Coagulation:
* International Normalized Ratio (INR) ≤ 1.5 ;
* Prothrombin Ratio (PR) ≤ 1.5 x UNL. 16. Patient having signed an informed consent form prior to any study specific procedure 17. Patient able, according to the investigator, to comply with study requirements, 18. Patient covered by a national health insurance 19. Female subjects should be using highly effective contraceptive measures during the study and 2 months after discontinuing osimertinib (highly effective methods of contraception have a failure rate of \< 1% when used consistently and correctly), and must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
* Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
* Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution
* Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation 20. Male subjects should be willing to use highly effective barrier contraception during the study and for 4 months after discontinuing osimertinib
2. Patients with brain and/or leptomeningeal metastases. 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.
3. Presence of an activating EGFR mutation. The following mutations are considered to be activating: L858R, exon 19 deletions, exon 19 insertions, L861Q, G719X. The inclusion of patients with other mutations should be discussed on a case-by-case basis with IFCT.
The presence of co-mutations on an oncogenic driver should be discussed with the IFCT before inclusion of the patient.
4. Testing for T790M mutation in circulating tumour DNA or tumour tissue sample at progression on the last treatment received before inclusion.
5. Maximum lines of anti-cancer treatment received before inclusion:
* For Cohort 1, patients could have been previously treated with maximum 3 lines of anti-cancer treatment.
* For cohort 2, patients could have been previously treated with maximum 1 line of anti-cancer treatment.
In case of previous chemotherapy, a wash-out period of 28 days will be applied. If there was any prior therapy with an investigational agent, a washout period of five half-lives of the compound or 3 months, whichever is greater, is needed.
6. Patient having recovered from all grade ≤ 1 toxicities related to previous anticancer therapies (CTCAE v 5.0) except for alopecia, platinum-therapy-related neuropathy (where ≤2 is allowed).
8\. Presence of at least one evaluable lesion not previously irradiated according to RECIST 1.1. For cohort 2, presence of one CNS evaluable lesion not previously irradiated according to RECIST 1.1.The radiological assessment has to be done within the timelines indicated.
9\. Age of at least 18 years old. 10. Performance status (PS) 0 to 2 (ECOG) except for patients with leptomeningeal carcinomatosis (cohort 1) a PS 3 is authorised.
11\. Patient with a life expectancy of ≥ 6 weeks for cohort 1 and ≥ 12 weeks for cohort 2.
12\. Haematological function:
* Absolute number of neutrophils ≥ 1.5 x 109/L;
* Platelets ≥ 100 x 109/L;
* Haemoglobin ≥ 9 g/dL (transfusions to maintain or exceed this value are accepted).
13\. Hepatic function:
* Total bilirubin ≤ 1.5 x UNL (Upper Normal Limit) or ≤ 3 x UNL in case of documented Gilbert's syndrome or liver metastases;
* AST / ALT \< 2.5 x UNL if no liver metastases or \< 5 x UNL in case of liver metastases.
14\. Renal function: Creatinine ≤1.5 x UNL. If creatinine \> 1.5 x UNL, Creatinine clearance must be ≥ 50 mL/min (Cockroft or MDRD or CKD-epi) 15. Coagulation:
* International Normalized Ratio (INR) ≤ 1.5 ;
* Prothrombin Ratio (PR) ≤ 1.5 x UNL. 16. Patient having signed an informed consent form prior to any study specific procedure 17. Patient able, according to the investigator, to comply with study requirements, 18. Patient covered by a national health insurance 19. Female subjects should be using highly effective contraceptive measures during the study and 2 months after discontinuing osimertinib (highly effective methods of contraception have a failure rate of \< 1% when used consistently and correctly), and must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
* Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
* Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution
* Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation 20. Male subjects should be willing to use highly effective barrier contraception during the study and for 4 months after discontinuing osimertinib
Exclusion Criteria
1. Small cell lung cancer histology (SCLC) or tumours with mixt histology including a SCLC component.
2. Previous treatment with osimertinib or another 3rd generation EGFR inhibitor.
3. Previous treatment with any EGFR TKI (cohort 2 only)
4. Brain progression requiring whole brain radiation without delay.
5. Local treatments (neurosurgical or stereotactic treatment) for brain metastases performed less than 2 weeks prior to enrolment.
6. Local brain treatment scheduled during study treatment.
7. Patient who received radiotherapy including the lung fields ≤ 4 weeks before enrolment or patient who has not recovered from radiotherapy-induced toxicities. For all other body sites (including radiotherapy on thoracic vertebrae and ribs), radiotherapy ≤ 2 weeks before enrolment or who have not recovered from radiotherapy-induced toxicities. Palliative radiotherapy for bone lesions ≤ 2 weeks before enrolment is authorised.
8. Any of the following cardiac criteria:
* Mean resting corrected QT interval (QTc) \> 470 msec using the screening clinic ECG machine derived QTc value
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block and second degree heart block).
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum/plasma potassium \< LLN; Serum/plasma magnesium \< LLN; Serum/plasma calcium \< LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes.
9. Active malignant disease other than NSCLC.
10. Previous or active cancer within the previous 3 years (except for treated carcinoma in situ of the cervix or basal cell skin cancer).
11. Others on-going anti-cancer treatment (including hormone therapy).
12. Major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic) during the 4 weeks before enrolment or patient who has not recovered from the side effects of such as procedure.
13. Current severe infectious disease or fever \> 38.5°C or evidence of any other pathology, degradation of organic or neurological functions, result of the physical examination or laboratory tests leading to suspect disease or a condition contra-indicating the use of the study treatment, which can impair the patient's compliance to the protocol conditions or expose to any possible risk of complications related to treatment.
14. Clinically significant heart disease (e.g. active): stroke or myocardial infarction in the 6 months prior to inclusion, unstable angina, congestive heart failure grade \> II according to New York Heart Association (NYHA) parameters, or cardiac arrhythmia requiring specific treatment during the study which could interfere with study compliance or which is not controlled by a treatment.
15. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).Active infection will include any patients receiving treatment for infection. Participants with a resolved or chronic infection HBV are eligible if they are:
* Negative for HBsAg and positive for hepatitis B core antibody \[anti-HBc IgG\] or
* Positive for HBsAg, negative for HBeAg but for \> 6 months have had transaminases levels below ULN and HBV DNA levels below 2000 IU/mL (i.e., are in an inactive carrier state).
16. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib
17. History of hypersensitivity to any of the active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
18. Currently receiving (or unable to stop use at least 3 week prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (see Appendix 2). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.
19. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
20. Patient who is subject to legal protection or who is unable to express his will.
21. Patient with a deficiency preventing complete understanding of the study requirements.
22. Patient having already been included and treated in this study or in another clinical trial (except for biological trials consisting of taking samples only).
23. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
2. Previous treatment with osimertinib or another 3rd generation EGFR inhibitor.
3. Previous treatment with any EGFR TKI (cohort 2 only)
4. Brain progression requiring whole brain radiation without delay.
5. Local treatments (neurosurgical or stereotactic treatment) for brain metastases performed less than 2 weeks prior to enrolment.
6. Local brain treatment scheduled during study treatment.
7. Patient who received radiotherapy including the lung fields ≤ 4 weeks before enrolment or patient who has not recovered from radiotherapy-induced toxicities. For all other body sites (including radiotherapy on thoracic vertebrae and ribs), radiotherapy ≤ 2 weeks before enrolment or who have not recovered from radiotherapy-induced toxicities. Palliative radiotherapy for bone lesions ≤ 2 weeks before enrolment is authorised.
8. Any of the following cardiac criteria:
* Mean resting corrected QT interval (QTc) \> 470 msec using the screening clinic ECG machine derived QTc value
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block and second degree heart block).
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum/plasma potassium \< LLN; Serum/plasma magnesium \< LLN; Serum/plasma calcium \< LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes.
9. Active malignant disease other than NSCLC.
10. Previous or active cancer within the previous 3 years (except for treated carcinoma in situ of the cervix or basal cell skin cancer).
11. Others on-going anti-cancer treatment (including hormone therapy).
12. Major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic) during the 4 weeks before enrolment or patient who has not recovered from the side effects of such as procedure.
13. Current severe infectious disease or fever \> 38.5°C or evidence of any other pathology, degradation of organic or neurological functions, result of the physical examination or laboratory tests leading to suspect disease or a condition contra-indicating the use of the study treatment, which can impair the patient's compliance to the protocol conditions or expose to any possible risk of complications related to treatment.
14. Clinically significant heart disease (e.g. active): stroke or myocardial infarction in the 6 months prior to inclusion, unstable angina, congestive heart failure grade \> II according to New York Heart Association (NYHA) parameters, or cardiac arrhythmia requiring specific treatment during the study which could interfere with study compliance or which is not controlled by a treatment.
15. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).Active infection will include any patients receiving treatment for infection. Participants with a resolved or chronic infection HBV are eligible if they are:
* Negative for HBsAg and positive for hepatitis B core antibody \[anti-HBc IgG\] or
* Positive for HBsAg, negative for HBeAg but for \> 6 months have had transaminases levels below ULN and HBV DNA levels below 2000 IU/mL (i.e., are in an inactive carrier state).
16. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib
17. History of hypersensitivity to any of the active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
18. Currently receiving (or unable to stop use at least 3 week prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (see Appendix 2). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.
19. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
20. Patient who is subject to legal protection or who is unable to express his will.
21. Patient with a deficiency preventing complete understanding of the study requirements.
22. Patient having already been included and treated in this study or in another clinical trial (except for biological trials consisting of taking samples only).
23. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Intergroupe Francophone de Cancerologie Thoracique
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David PLANCHARD
Role: PRINCIPAL_INVESTIGATOR
Intergroupe Francophone de Cancerologie Thoracique
Franck MORIN
Role: STUDY_DIRECTOR
Intergroupe Francophone de Cancerologie Thoracique
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier Aix-Pertuis
Aix-en-Provence, , France
Site Status
CHU Amiens - Groupe Hospitalier Sud
Amiens, , France
Site Status
Centre Paul Papin
Angers, , France
Site Status
Hôpital privé d'Antony
Antony, , France
Site Status
Institut Sainte Catherine
Avignon, , France
Site Status
Centre Hospitalier de la Côte Basque
Bayonne, , France
Site Status
CHU Besançon - Hôpital J. MINJOZ
Besançon, , France
Site Status
Groupe Hospitalier Saint André
Bordeaux, , France
Site Status
AP-HP Hôpital Ambroise Paré
Boulogne, , France
Site Status
CHU Côte de Nacre
Caen, , France
Site Status
Hôpital Louis Pasteur
Colmar, , France
Site Status
Centre Hospitalier Intercommunal de Créteil
Créteil, , France
Site Status
CHU Hôpital du Bocage
Dijon, , France
Site Status
Chu Grenoble
Grenoble, , France
Site Status
Centre Hospitalier Général
Le Mans, , France
Site Status
Hôpital Calmette
Lille, , France
Site Status
CHU Dupuytren
Limoges, , France
Site Status
Institut Paoli Calmettes
Marseille, , France
Site Status
Marseille Hôpital Nord
Marseille, , France
Site Status
CHU Montpellier
Montpellier, , France
Site Status
Centre Hospitalier Régional - Hôpital de la Source
Orléans, , France
Site Status
AP-HP Hôpital Cochin
Paris, , France
Site Status
AP-HP Hôpital Bichat
Paris, , France
Site Status
Centre Hospitalier Général - Pau
Pau, , France
Site Status
Lyon - URCOT Centre Hospitalier Universitaire
Pierre-Bénite, , France
Site Status
CHU de la Réunion - Site Felix Guyon
Saint-Denis, , France
Site Status
Institut de Cancérologie de l'Ouest - René Gauducheau
Saint-Herblain, , France
Site Status
CHU de La Réunion-Site Sud
Saint-Pierre, , France
Site Status
Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Site Status
Hôpital Foch
Suresnes, , France
Site Status
HIA Sainte-Anne
Toulon, , France
Site Status
Hôpital Larrey
Toulouse, , France
Site Status
CHU Bretonneau
Tours, , France
Site Status
Valenciennes Clinique PRIV
Valenciennes, , France
Site Status
Centre Hospitalier de Villefranche-sur-Saône
Villefranche-sur-Saône, , France
Site Status
Gustave Roussy
Villejuif, , France
Site Status
Countries
Review the countries where the study has at least one active or historical site.
France
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IFCT-1804
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation
NCT03414814
COMPLETED
PHASE2
Osimertinib for NSCLC With Uncommon EGFR Mutations
NCT05421936
SUSPENDED
Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC
NCT03769103
ACTIVE_NOT_RECRUITING
PHASE2
A Study of Osimertinib-based Adaptive Treatment Guided by ctDNA EGFRm+ Monitoring in NSCLC
NCT07058519
RECRUITING
PHASE2
Efficacy and Safety of 80mg Osimertinib in Patients With Non-small Cell Lung Cancer(NSCLC)
NCT04563871
COMPLETED
PHASE2
Osimertinib With Bevacizumab for Leptomeningeal Metastasis From EGFR-mutation Non-Small Cell Lung Cancer
NCT04425681
UNKNOWN
PHASE2
A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)
NCT05526755
ACTIVE_NOT_RECRUITING
PHASE2
Efficacy of Osimertinib in Patients With Lung Cancer
NCT06174857
RECRUITING
Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC
NCT05215951
TERMINATED
PHASE2
A Randomised Phase II Trial of Osimertinib With or Without SRS for EGFR Mutated NSCLC With Brain Metastases
NCT03497767
COMPLETED
PHASE2
Almonertinib Versus Osimertinib in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases
NCT04870190
UNKNOWN
PHASE3
Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC
NCT06376084
ACTIVE_NOT_RECRUITING
Osimertinib With Stereotactic Radiosurgery (SRS) in Brain Metastases From EGFR Positive NSCLC
NCT03535363
COMPLETED
PHASE1
Real-World Effectiveness of Osimertinib for Patients With Non-Small Cell Lung Cancer
NCT05513664
UNKNOWN
Osimertinib Combined With Bevacizumab in Patients With Brain Metastasis Epidermal Growth Factor Receptor (EGFR) Mutation Positive Metastatic Non-Small Cell Lung Cancer
NCT05104281
UNKNOWN
PHASE3
Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm
NCT05546866
ACTIVE_NOT_RECRUITING
PHASE2
Osimertinib With or Without Bevacizumab for EGFR- Mutant Non-small Cell Lung Cancer With Leptomeningeal Metastasis
NCT04148898
UNKNOWN
PHASE2
High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases
NCT06319950
NOT_YET_RECRUITING
PHASE2
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
NCT06391944
ACTIVE_NOT_RECRUITING
PHASE2
Osimertinib for Advanced EGFR-positive NSCLC Patients
NCT05037331
RECRUITING
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
NCT03191149
RECRUITING
PHASE2
A Study to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases
NCT05033691
RECRUITING
NA
To Evaluate the Efficacy/Safety of Osimertinib Prior to CRT and Maintenance of it With Stage III, Unresectable NSCLC With EGFR Mutations
NCT06194448
ACTIVE_NOT_RECRUITING
PHASE2