Non-small Cell Lung CancerPhase 4OSIBOOST 2NCT05748093
Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat
A Phase 4 study testing Cobicistat in people with Non-small Cell Lung Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to assess the feasibility of pharmacokinetically boosting osimertinib using cobicistat in order to improve osimertinib exposure in individual patients with advanced NSCLC (Non-Small Cell Lung Cancer) with mutated EGFR (Epidermal Growth Factor Receptor). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Cobicistat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2024to 1 Sep 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this cohort 1, a subject must meet all of the following criteria:
- The patient is set to receive osimertinib 80 mg QD as part of their standard treatment plan
- The patient has a World Health Organization (WHO) Performance Status (PS) of ≤2.
- The patient is 18 years or older
- The patient is able and willing to sign informed consent
- The patient is able and willing to undergo blood sampling
Show all 15Show fewer
- The patient has non-squamous advanced EGFR-mutated NSCLC with no signs of imminent progression (CT confirmed). If the patient does have signs of progression, they are only eligible if their treating physician deems the treatment to be appropriate beyond progression.
- The patient consents to their blood being analysed for CYP3A-genotype
- In order to be eligible to participate in this cohort 2, a subject must meet all of the following criteria:
- The patient is set to receive osimertinib 80 mg QD as part of their standard treatment plan
- The patient has a World Health Organization (WHO) Performance Status (PS) of ≤2.
- The patient is 18 years or older
- The patient is able and willing to sign informed consent
- The patient is able and willing to undergo blood sampling
- The patient has non-squamous EGFR-mutated NSCLC with radiologically confirmed progressive (RECIST v1.1), but asymptomatic intracranial metastasis, not in an eloquent area (to be discussed with neurologist). Furthermore, the disease is controlled extracranially (no RECIST v1.1 progression).
Who cannot join
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- The patient does not take any other drug which is known to strongly inhibit CYP3A4/CYP3A5 activity
- The patient does not take any other drug which is metabolized by CYP3A4/CYP3A5 and which has a small therapeutic window
- The patient does not take any drug or product which may otherwise affect CYP3A4/CYP3A5 metabolic activity
- The patient does not have impaired gastrointestinal function
- The patient is neither pregnant nor breastfeeding
- The patient does not have any contra-indication for cobicistat prescription, as listed in the summary of product characteristics for cobicistat
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
MaastrichtUMC
Maastricht, Limburg, 6229HX
Paul Kruithof, PharmD, MSc
About this study
Official title: Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat (OSIBOOST 2)
The goal of this clinical trial is to assess the feasibility of pharmacokinetically boosting osimertinib using cobicistat in order to improve osimertinib exposure in individual patients with advanced NSCLC (Non-Small Cell Lung Cancer) with mutated EGFR (Epidermal Growth Factor Receptor). The main questions it aims to answer are:
- Cohort 1: Does concurrent use of osimertinib and cobicistat allow for osimertinib weekly intake reductions? If so, how much can the intake be reduced while retaining clinically effective exposure?
- Cohort 2: Does concurrent use of osimertinib and cobicistat allow for improved penetration of osimertinib in the central nervous system, in patients with CNS (central nervous system) oligoprogression?
Participants who are taking osimertinib in regular care will receive cobicistat in addition to their other medication. They will undergo blood sampling to measure the amount of osimertinib in blood, and measure the effect of boosting. Additionally, in cohort 1 patients will be dose-reduced if their exposure levels allow.
Read the detailed description
In 2016 Osimertinib was registered for the treatment of patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with an activating Epidermal Growth Factor Receptor (EGFR) mutation, initially only for patients with the T790M resistance mutation, but since 2018 also in the first line treatment. Use of osimertinib in the first line provides improved overall survival and progression-free survival, more potent efficacy against brain metastases, and better tolerability compared to older generation EGFR tyrosine kinase inhibitors (EGFR-TKIs). The downside of osimertinib is that -like many new anticancer agents- it is highly expensive (over €70 000 per patient per year in the Netherlands). In a period of five years, healthcare costs associated with expensive medication have risen from €1.71 billion to €2.46 billion per year in the Netherlands. The Dutch Cancer Society has warned that this astronomical cost increase will start to suffocate the national health care budget. In order to safeguard sustained affordability and accessibility of oncological healthcare, improving cost-effectiveness of available drugs is of paramount importance. In a previous study, we have demonstrated that osimertinib exposure may be boosted, through concomitant use of cobicistat, as a result of CYP3A4 inhibition. We now aim to apply pharmacokinetic (PK) boosting in order to improve osimertinib exposure and cost-effectiveness, without impacting treatment efficacy and safety.
This trial is designed to study whether pharmacokinetic boosting may alleviate these issues. In the first cohort, we will assess whether PK-boosting is able to reduce the amount of osimertinib which a patient needs to take. In order to assess this, the patient will receive cobicistat (the booster drug) and we will measure the amount of osimertinib and its metabolite in blood. Afterwards, the researchers and physicians may calculate how much osimertinib a patient actually needs. Ideally this will both reduce the amount of osimertinib that a patient needs to take, as well as reduce the price-tag of the overall treatment. In the second cohort, we will assess whether PK-boosting is a viable alternative to dose-doubling osimertinib. Some patients with NSCLC develop progressive CNS metastases despite osimertinib therapy. There is an indication that increasing the osimertinib dosage to double the standard therapy might provide longer/better treatment efficacy in these patients. Because of the tremendous cost associated with double-dosing osimertinib, most health care insurance providers in the Netherlands do not cover this therapy. In cohort 2 we look to find out whether PK-boosting might provide a similar effect to increasing the dosage, for a far more affordable price-tag.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Cobicistat
- Keywords
- Osimertinib, Cobicistat, Pharmacokinetics, Boosting, Non-small Cell Lung Cancer, CNS metastases
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CobicistatDrug
Also called Tybost
Feasibility of pharmacokinetic boosting using cobicistat for personalized treatment strategies for osimertinib.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Adjusting osimertinib treatment plans with concomitant pk-boosting | Experimental | Feasibility of using pharmacokinetic boosting and TDM to individualize treatment plans and dosage for osimertinib, in patients with advanced NSCLC with mutated EGFR. In this cohort, patients will receive cobicistat for pharmacokinetic boosting of standard osimertinib treatment. Afterwards, they will receive personalised treatment plans, guided by therapeutic drug monitoring. Receives: Drug: Cobicistat |
| Cohort 2: Improving osimertinib CNS penetration in patients with neurometastases | Experimental | Assessing whether pharmacokinetic boosting can improve CNS penetration of osimertinib, in patients with advanced NSCLC with mutated EGFR with asymptomatic CNS oligoprogression. Patients who experience progressive disease intracranially, are sometimes dose-escalated to try and improve osimertinib intracranial exposure. This study will look to demonstrate the feasibility of using a PK-booster instead, potentially providing patients the benefits of higher intracranial treatment efficacy, without needing to take extra osimertinib. Receives: Drug: Cobicistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1 primary end-point: Dose modification feasibility
This cohort aims to demonstrate feasibility and clinical applicability of PK-boosting in the oncological setting. PK-boosting will increase osimertinib availability in plasma. When the availability is increased, a patient will require less osimertinib to achieve the same effect. Therefore, they can be dose-reduced in order to restore them to their normal exposure. In order for this treatment to be considered feasible, the following conditions need to be met: a patient needs to have a stable osimertinib exposure when using the PK-booster, and the patient needs to be dose-modified as a result. The primary endpoint will describe the amount of patients who have: stable exposure; similar to their respective baseline; while using concomitant pk-boosting therapy and a dose modified osimertinib treatment plan; without experiencing significant toxicity. The aim is for this treatment strategy to be considered feasible for at least 75% of patients.
Measured: 2-18 months after intervention initiation
Cohort 2 primary end-point: Disease Control Rate at 12 weeks
This cohort aims to provide improved treatment efficacy in patients with intracranial metastases from NSCLC. Osimertinib penetration in the CNS is much better than that of older generation TKIs, but it is still only 1,49%. Many patients with NSCLC end up developing CNS metastases, a condition known for its dismal prognosis. Currently the only way to increase osimertinib CNS penetration is through dose-escalation: a strategy which causes a tremendous increase in treatment-related toxicity. This cohort looks to improve CNS penetration of osimertinib through the use of a PK-booster (cobicistat). In order to assess treatment efficacy, a MRI will be taken at the start of the trial, and after 12 weeks. A neuro-radiology panel will then assess metastatic response rate. This metastatic response rate will be compared to historical data in order to assess the intracranial treatment efficacy.
Measured: 12 weeks after intervention initiation
Secondary outcomes (6)
Cohort 1 secondary end-point: plasma concentrations of osimertinib and AZ5104
In order to assess the extent of pharmacokinetic boosting in plasma, the plasma concentrations of osimertinib and AZ5104 (metabolite) will be determined.
Measured: 2-18 months after intervention initiation
Cohort 1 secondary end-point: safety set
Number of (serious) adverse events as graded by CTCAE
Measured: 2-18 months after intervention initiation
Cohort 1 secondary end-point: Cost-effectiveness analysis
If in cohort 1 the overall treatment is considered "feasible". An assessment of overall average treatment cost per patient per day will be made for the experimental treatment plan. This will be compared to the current standard treatment cost using a Health-Technology Assessment (HTA). If efficacy endpoints cannot be determined, but the trial treatment is considered "feasible", then the trial treatment will be assessed as "non-inferior" (as the TDM-strategy looks to maintain similar drug exposure).
Measured: 2-18 months after intervention initiation
Cohort 1 secondary end-point: CYP3A predictiveness for osimertinib exposure
Assessing predictiveness of CYP3A-polymorphism for osimertinib exposure. This will be done by statistically comparing osimertinib exposure for patient groups with different genotypes.
Measured: 2-18 months after intervention initiation
Cohort 2 secondary end-point: plasma concentrations of osimertinib and AZ5104
In order to assess the extent of pharmacokinetic boosting in plasma, the plasma concentrations of osimertinib and AZ5104 (metabolite) will be determined.
Measured: 12 weeks after intervention initiation
Cohort 2 secondary end-point: safety set
Number of (serious) adverse events as graded by CTCAE
Measured: 12 weeks after intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Apr 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study will involve two cohorts, which will both receive PK-boosting, but for different purposes, and with different primary outcomes. The cohorts will not be compared, and there will be no cross-over between cohorts.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lizza Hendriks, MD, PhD, Principal investigator, Maastricht University Medical Centre+
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748093
- Sponsor's protocol ID
- OSIBOOST 2
- Other IDs
- 2023-505700-35-00, 2023
- Acronym
- OSIBOOST 2
- Status last verified
- Aug 2024
- First submitted
- 2 Feb 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Veelen A, Gulikers J, Hendriks LEL, Dursun S, Ippel J, Smit EF, Dingemans AC, van Geel R, Croes S. Pharmacokinetic boosting of osimertinib with cobicistat in patients with non-small cell lung cancer: The OSIBOOST trial. Lung Cancer. 2022 Sep;171:97-102. doi: 10.1016/j.lungcan.2022.07.012. Epub 2022 Jul 25.
PubMed 35933915Soria JC, Ohe Y, Vansteenkiste J, Reungwetwattana T, Chewaskulyong B, Lee KH, Dechaphunkul A, Imamura F, Nogami N, Kurata T, Okamoto I, Zhou C, Cho BC, Cheng Y, Cho EK, Voon PJ, Planchard D, Su WC, Gray JE, Lee SM, Hodge R, Marotti M, Rukazenkov Y, Ramalingam SS; FLAURA Investigators. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Jan 11;378(2):113-125. doi: 10.1056/NEJMoa1713137. Epub 2017 Nov 18.
PubMed 29151359
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat (OSIBOOST 2)
- ClinicalTrials.gov ID
- NCT05748093
- Acronym / sponsor ID
- OSIBOOST 2 / OSIBOOST 2
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Osimertinib, Cobicistat, Pharmacokinetics, Boosting, Non-small Cell Lung Cancer, CNS metastases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the feasibility of pharmacokinetically boosting osimertinib using cobicistat in order to improve osimertinib exposure in individual patients with advanced NSCLC (Non-Small Cell Lung Cancer) with mutated EGFR (Epidermal Growth Factor Receptor). The main questions it aims to answer are:
- Cohort 1: Does concurrent use of osimertinib and cobicistat allow for osimertinib weekly intake reductions? If so, how much can the intake be reduced while retaining clinically effective exposure?
- Cohort 2: Does concurrent use of osimertinib and cobicistat allow for improved penetration of osimertinib in the central nervous system, in patients with CNS (central nervous system) oligoprogression?
Participants who are taking osimertinib in regular care will receive cobicistat in addition to their other medication. They will undergo blood sampling to measure the amount of osimertinib in blood, and measure the effect of boosting. Additionally, in cohort 1 patients will be dose-reduced if their exposure levels allow.
Detailed description
In 2016 Osimertinib was registered for the treatment of patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with an activating Epidermal Growth Factor Receptor (EGFR) mutation, initially only for patients with the T790M resistance mutation, but since 2018 also in the first line treatment. Use of osimertinib in the first line provides improved overall survival and progression-free survival, more potent efficacy against brain metastases, and better tolerability compared to older generation EGFR tyrosine kinase inhibitors (EGFR-TKIs). The downside of osimertinib is that -like many new anticancer agents- it is highly expensive (over €70 000 per patient per year in the Netherlands). In a period of five years, healthcare costs associated with expensive medication have risen from €1.71 billion to €2.46 billion per year in the Netherlands. The Dutch Cancer Society has warned that this astronomical cost increase will start to suffocate the national health care budget. In order to safeguard sustained affordability and accessibility of oncological healthcare, improving cost-effectiveness of available drugs is of paramount importance. In a previous study, we have demonstrated that osimertinib exposure may be boosted, through concomitant use of cobicistat, as a result of CYP3A4 inhibition. We now aim to apply pharmacokinetic (PK) boosting in order to improve osimertinib exposure and cost-effectiveness, without impacting treatment efficacy and safety.
This trial is designed to study whether pharmacokinetic boosting may alleviate these issues. In the first cohort, we will assess whether PK-boosting is able to reduce the amount of osimertinib which a patient needs to take. In order to assess this, the patient will receive cobicistat (the booster drug) and we will measure the amount of osimertinib and its metabolite in blood. Afterwards, the researchers and physicians may calculate how much osimertinib a patient actually needs. Ideally this will both reduce the amount of osimertinib that a patient needs to take, as well as reduce the price-tag of the overall treatment. In the second cohort, we will assess whether PK-boosting is a viable alternative to dose-doubling osimertinib. Some patients with NSCLC develop progressive CNS metastases despite osimertinib therapy. There is an indication that increasing the osimertinib dosage to double the standard therapy might provide longer/better treatment efficacy in these patients. Because of the tremendous cost associated with double-dosing osimertinib, most health care insurance providers in the Netherlands do not cover this therapy. In cohort 2 we look to find out whether PK-boosting might provide a similar effect to increasing the dosage, for a far more affordable price-tag.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will involve two cohorts, which will both receive PK-boosting, but for different purposes, and with different primary outcomes. The cohorts will not be compared, and there will be no cross-over between cohorts.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Adjusting osimertinib treatment plans with concomitant pk-boosting | Experimental | Drug: CobicistatFeasibility of using pharmacokinetic boosting and TDM to individualize treatment plans and dosage for osimertinib, in patients with advanced NSCLC with mutated EGFR. In this cohort, patients will receive cobicistat for pharmacokinetic boosting of standard osimertinib treatment. Afterwards, they will receive personalised treatment plans, guided by therapeutic drug monitoring. |
| Cohort 2: Improving osimertinib CNS penetration in patients with neurometastases | Experimental | Drug: CobicistatAssessing whether pharmacokinetic boosting can improve CNS penetration of osimertinib, in patients with advanced NSCLC with mutated EGFR with asymptomatic CNS oligoprogression. Patients who experience progressive disease intracranially, are sometimes dose-escalated to try and improve osimertinib intracranial exposure. This study will look to demonstrate the feasibility of using a PK-booster instead, potentially providing patients the benefits of higher intracranial treatment efficacy, without needing to take extra osimertinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- In order to be eligible to participate in this cohort 1, a subject must meet all of the following criteria:
- The patient is set to receive osimertinib 80 mg QD as part of their standard treatment plan
- The patient has a World Health Organization (WHO) Performance Status (PS) of ≤2.
- The patient is 18 years or older
- The patient is able and willing to sign informed consent
Key exclusion criteria (7 listed)
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- The patient does not take any other drug which is known to strongly inhibit CYP3A4/CYP3A5 activity
- The patient does not take any other drug which is metabolized by CYP3A4/CYP3A5 and which has a small therapeutic window
- The patient does not take any drug or product which may otherwise affect CYP3A4/CYP3A5 metabolic activity
- The patient does not have impaired gastrointestinal function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CobicistatAlso: TybostFeasibility of pharmacokinetic boosting using cobicistat for personalized treatment strategies for osimertinib. | Drug | Cohort 1: Adjusting osimertinib treatment plans with concomitant pk-boosting, Cohort 2: Improving osimertinib CNS penetration in patients with neurometastases |
Primary outcome
Cohort 1 primary end-point: Dose modification feasibility
Time frame: 2-18 months after intervention initiation
This cohort aims to demonstrate feasibility and clinical applicability of PK-boosting in the oncological setting. PK-boosting will increase osimertinib availability in plasma. When the availability is increased, a patient will require less osimertinib to achieve the same effect. Therefore, they can be dose-reduced in order to restore them to their normal exposure. In order for this treatment to be considered feasible, the following conditions need to be met: a patient needs to have a stable osimertinib exposure when using the PK-booster, and the patient needs to be dose-modified as a result. The primary endpoint will describe the amount of patients who have: stable exposure; similar to their respective baseline; while using concomitant pk-boosting therapy and a dose modified osimertinib treatment plan; without experiencing significant toxicity. The aim is for this treatment strategy to be considered feasible for at least 75% of patients.
Cohort 2 primary end-point: Disease Control Rate at 12 weeks
Time frame: 12 weeks after intervention initiation
This cohort aims to provide improved treatment efficacy in patients with intracranial metastases from NSCLC. Osimertinib penetration in the CNS is much better than that of older generation TKIs, but it is still only 1,49%. Many patients with NSCLC end up developing CNS metastases, a condition known for its dismal prognosis. Currently the only way to increase osimertinib CNS penetration is through dose-escalation: a strategy which causes a tremendous increase in treatment-related toxicity. This cohort looks to improve CNS penetration of osimertinib through the use of a PK-booster (cobicistat). In order to assess treatment efficacy, a MRI will be taken at the start of the trial, and after 12 weeks. A neuro-radiology panel will then assess metastatic response rate. This metastatic response rate will be compared to historical data in order to assess the intracranial treatment efficacy.
6 secondary outcomes
Cohort 1 secondary end-point: plasma concentrations of osimertinib and AZ5104
Time frame: 2-18 months after intervention initiation
Cohort 1 secondary end-point: safety set
Time frame: 2-18 months after intervention initiation
Cohort 1 secondary end-point: Cost-effectiveness analysis
Time frame: 2-18 months after intervention initiation
Cohort 1 secondary end-point: CYP3A predictiveness for osimertinib exposure
Time frame: 2-18 months after intervention initiation
Cohort 2 secondary end-point: plasma concentrations of osimertinib and AZ5104
Time frame: 12 weeks after intervention initiation
Cohort 2 secondary end-point: safety set
Time frame: 12 weeks after intervention initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 35933915van Veelen A, Gulikers J, Hendriks LEL, Dursun S, Ippel J, Smit EF, Dingemans AC, van Geel R, Croes S. Pharmacokinetic boosting of osimertinib with cobicistat in patients with non-small cell lung cancer: The OSIBOOST trial. Lung Cancer. 2022 Sep;171:97-102. doi: 10.1016/j.lungcan.2022.07.012. Epub 2022 Jul 25.
- Background: PubMed 29151359Soria JC, Ohe Y, Vansteenkiste J, Reungwetwattana T, Chewaskulyong B, Lee KH, Dechaphunkul A, Imamura F, Nogami N, Kurata T, Okamoto I, Zhou C, Cho BC, Cheng Y, Cho EK, Voon PJ, Planchard D, Su WC, Gray JE, Lee SM, Hodge R, Marotti M, Rukazenkov Y, Ramalingam SS; FLAURA Investigators. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Jan 11;378(2):113-125. doi: 10.1056/NEJMoa1713137. Epub 2017 Nov 18.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
RecruitingPhase 3
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Non-small Cell Lung Cancer
Not yet recruitingPhase 1
A Phase 1 Trial of KAN-001 With Pembrolizumab, With or Without Chemotherapy, in Participants With PD-L1-Positive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
RecruitingPhase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lizza Hendriks, MD, PhD principal investigator
Maastricht University Medical Centre+
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cobicistat in people with Non-small Cell Lung Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Kruithof, PharmD, MSc (+31433871881, paul.kruithof@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1 primary end-point: Dose modification feasibility (time frame: 2-18 months after intervention initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05748093, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.