NSCLCPhase 4FLEXNCT06010277
Folinic Acid for Prevention of Pemetrexed-induced Toxicity
A Phase 4 study testing Folinic acid in people with NSCLC and Mesothelioma, run by Amphia Hospital at 2 sites in Netherlands.
Trial summary
Objective The main objective is to evaluate the haematological toxicity in patients who use pemetrexed with and without rescue therapy with folinic acid. Primary endpoint Difference between treatment groups in neutrophil count (*109/L) at day 8-10 after administration of pemetrexed (nadir). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Mesothelioma, Thymoma
- What is being tested?
- Folinic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesNetherlands
- Study dates
- 6 Feb 2023to Jan 2024
- 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
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- ≥18 years old
- Eligible for treatment with pemetrexed-based chemotherapy based on indication.
- ECOG performance score of 0-2.
- Subject is able and willing to sign the Informed Consent Form
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Contraindications for treatment with folinic acid in line with the SmPC.
- Hypersensitivity to the active substance or to any of the excipients.
- Anaemia caused by vitamin B12 deficiency.
- The presence of clinically relevant drug-drug interactions, according to the current SmPC of folinic acid.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Amphia Hospital
Breda, North Brabant, 4817
Ramon Contrucci, MSc, +31765954354, Rcontrucci@amphia.nl
Nikki de Rouw, Phd, +31765957757, NdeRouw@amphia.nl
- Not yet recruiting
Albert Schweitzer Hospital
Dordrecht, South Holland, 3318
Ramon Contrucci, MSc, +31765954354, RContrucci@amphia.nl
Charlotte van Kesteren, Phd, cvankesteren@asz.nl
About this study
Official title: The Effect of Oral Folinic Acid Rescue Therapy on Pemetrexed Induced Neutropenia: A Randomized Open-label Trial
Objective The main objective is to evaluate the haematological toxicity in patients who use pemetrexed with and without rescue therapy with folinic acid.
Primary endpoint Difference between treatment groups in neutrophil count (*109/L) at day 8-10 after administration of pemetrexed (nadir).
Read more
Secondary endpoints The grade neutropenia (according to the CTCAE version 5, 2017) at day 8-10, the homocysteine plasma levels at baseline (predictor for developing toxicity), the efficacy of chemotherapy treatment based on response CT after cycle 2 and 4 and the incidence of discontinuation, dose delays and dose reductions of pemetrexed.
Trial design The FLEX-trial is a multi-centre, open label, double arm, randomized trial to compare neutropenia in patients with and without folinic acid rescue therapy where subjects are participating for 4 treatment cycles.
Population In total 50 patients (25 in each arm), >18 years with stage IV non-small cell lung cancer (NSCLC) or mesothelioma treated with pemetrexed (in combination with other chemo- or immunotherapy) are eligible for inclusion.
Interventions Follow-up will take place during the first 4 cycles of chemotherapy with pemetrexed. Patients in the intervention-arm will receive oral folinic acid orally 4 times 45mg / day for 3 days, starting 24 hours after the administration of pemetrexed.
- Conditions
- NSCLC, Mesothelioma, Thymoma
- Being tested
- Folinic acid
- Medical subject headings
- Mesothelioma, Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folinic acidDrug
Follow-up will take place during the first 4 cycles of chemotherapy with pemetrexed. Patients in the intervention-arm will receive oral folinic acid orally 4 times 45mg / day for 3 days, starting 24 hours after the administration of pemetrexed.
| Study group | Role | What they receive |
|---|---|---|
| Folinic acid arm | Experimental | Patients in the intervention-arm will receive oral folinic acid orally 4 times 45mg / day for 3 days, starting 24 hours after the administration of pemetrexed. Receives: Drug: Folinic acid |
| No folinic acid arm | No intervention | Patients will be treated according to regular care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in neutrophil count (*109/L) at day 8-10 after pemetrexed administration during 2 cycles of chemotherapy
To evaluate the haematological toxicity (continuous measure) in patients who use pemetrexed with and without rescue therapy with folinic acid.
Measured: Between day 8-10 in the first 2 cycles (each cycle is 21 days)
Secondary outcomes (4)
Grade neutropenia (according to the CTCAE version 5, 2017) at day 8-10 after pemetrexed administration during 2 cycles of chemotherapy
To evaluate the difference in haematological toxicity based on the CTCAE criteria for neutrophil count
Measured: Between day 8-10 in the first 2 cycles (each cycle is 21 days)
Homocysteine plasma levels at baseline (μmol/L)
To evaluate the influence of baseline homocysteine plasma levels on occurrence of haematological toxicity.
Measured: Once, before the start of the first cycle (each cycle is 21 days)
Efficacy based on response CT after cycle 2 and 4 (categorical: response, partial response, progression)
To evaluate the efficacy of the treatment with pemetrexed (based on CT-scan).
Measured: After the second and fourth cycle (each cycle is 21 days)
Incidence of discontinuation, dose delays and dose reductions of pemetrexed
To evaluate the incidence of treatment delay or dose reduction of pemetrexed.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start6 Feb 2023
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amphia Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Schweitzer Hospital
- Responsible party
- Principal investigator, Dr. N. (Nikki) de Rouw, Amphia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010277
- Sponsor's protocol ID
- 1891
- Acronym
- FLEX
- Status last verified
- Aug 2023
- First submitted
- 26 Jan 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Folinic Acid Rescue Therapy on Pemetrexed Induced Neutropenia: A Randomized Open-label Trial
- ClinicalTrials.gov ID
- NCT06010277
- Acronym / sponsor ID
- FLEX / 1891
- Conditions
- NSCLC, Mesothelioma, Thymoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Amphia HospitalUniversity, hospital or other
- Collaborators
- Albert Schweitzer Hospital
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 24 Aug 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.
Objective The main objective is to evaluate the haematological toxicity in patients who use pemetrexed with and without rescue therapy with folinic acid.
Primary endpoint Difference between treatment groups in neutrophil count (*109/L) at day 8-10 after administration of pemetrexed (nadir).
Secondary endpoints The grade neutropenia (according to the CTCAE version 5, 2017) at day 8-10, the homocysteine plasma levels at baseline (predictor for developing toxicity), the efficacy of chemotherapy treatment based on response CT after cycle 2 and 4 and the incidence of discontinuation, dose delays and dose reductions of pemetrexed.
Trial design The FLEX-trial is a multi-centre, open label, double arm, randomized trial to compare neutropenia in patients with and without folinic acid rescue therapy where subjects are participating for 4 treatment cycles.
Population In total 50 patients (25 in each arm), >18 years with stage IV non-small cell lung cancer (NSCLC) or mesothelioma treated with pemetrexed (in combination with other chemo- or immunotherapy) are eligible for inclusion.
Interventions Follow-up will take place during the first 4 cycles of chemotherapy with pemetrexed. Patients in the intervention-arm will receive oral folinic acid orally 4 times 45mg / day for 3 days, starting 24 hours after the administration of pemetrexed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folinic acid arm | Experimental | Drug: Folinic acidPatients in the intervention-arm will receive oral folinic acid orally 4 times 45mg / day for 3 days, starting 24 hours after the administration of pemetrexed. |
| No folinic acid arm | No intervention | –Patients will be treated according to regular care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Folinic acidFollow-up will take place during the first 4 cycles of chemotherapy with pemetrexed. Patients in the intervention-arm will receive oral folinic acid orally 4 times 45mg / day for 3 days, starting 24 hours after the administration of pemetrexed. | Drug | Folinic acid arm |
Primary outcome
Difference in neutrophil count (*109/L) at day 8-10 after pemetrexed administration during 2 cycles of chemotherapy
Time frame: Between day 8-10 in the first 2 cycles (each cycle is 21 days)
To evaluate the haematological toxicity (continuous measure) in patients who use pemetrexed with and without rescue therapy with folinic acid.
4 secondary outcomes
Grade neutropenia (according to the CTCAE version 5, 2017) at day 8-10 after pemetrexed administration during 2 cycles of chemotherapy
Time frame: Between day 8-10 in the first 2 cycles (each cycle is 21 days)
Homocysteine plasma levels at baseline (μmol/L)
Time frame: Once, before the start of the first cycle (each cycle is 21 days)
Efficacy based on response CT after cycle 2 and 4 (categorical: response, partial response, progression)
Time frame: After the second and fourth cycle (each cycle is 21 days)
Incidence of discontinuation, dose delays and dose reductions of pemetrexed
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Folinic acid in people with NSCLC and Mesothelioma, run by Amphia Hospital at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Ramon Contrucci, MSc (0765954354, rcontrucci@amphia.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in neutrophil count (*109/L) at day 8-10 after pemetrexed administration during 2 cycles of chemotherapy (time frame: Between day 8-10 in the first 2 cycles (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2023.