Non-small Cell Lung Carcinoma (NSCLC)Phase 2NCT04460729
A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, NSCLC With Brain Metastases
A Phase 2 study testing Capmatinib in people with Non-small Cell Lung Carcinoma (NSCLC), run by Novartis Pharmaceuticals.
Trial summary
The purpose of this study is to establish the intracranial efficacy of single agent capmatinib in the population of treatment-naïve or pretreated with one or two prior lines of systemic therapies for advanced stage Non Small-Cell Lung Cancer (NSCLC) with MET exon 14 mutation that has metastasized to the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Carcinoma (NSCLC)
- What is being tested?
- Capmatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2020to 17 Nov 2023
- Phase
- Phase 2
- 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
- Histologically confirmed stage IV (according to Version 8 of the American Joint Committee on Cancer (AJCC)) NSCLC that is EGFR wt, ALK rearrangement negative as assessed by a validated test as part of the participant's standard of care and has MET∆ex14 mutation per Novartis-designated central laboratory or (US only) locally with FoundationOne Companion Diagnostic (F1CDx) .
- Treatment naïve or up to two prior lines of systemic therapy for stage IIIb-IV NSCLC
- Measurable intracranial lesions:
- Cohort 1 and Cohort 2 (without leptomeningeal carcinoma): At least 1 measurable intracranial lesion per RANO-BM criteria, documented by a radiologist/neuroradiologist (treated or untreated).
- Cohort 2 (with leptomeningeal carcinoma): participants with leptomeningeal carcinoma may not have measurable lesions. In this circumstance, the participant's disease will be considered to have non-target lesions only at baseline and their response based on descriptive clinical criteria by physician assessment.
- Capable of undergoing magnetic resonance imaging (MRI)
- ECOG performance status of 0 or 1
Who cannot join
- Only for Cohort 1: any neurological symptoms related to brain metastases
- For participants in Cohort 2 with prior brain therapy: Treatment with stereotactic radiosurgery within 14 days prior to the start of study treatment or treatment with WBRT within 14 days prior to the start of study treatment
- Prior treatment with any MET targeting therapy or HGF inhibitor
- Participants with other known druggable molecular alterations (such as ROS1 translocation or BRAF mutation) who might be candidates to alternative targeted therapies as applicable per local regulations and treatment guidelines
- Presence or history of ILD or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
- Clinically significant, uncontrolled heart diseases including History of familial long QT syndrome, sudden death or congenital long QT syndrome
- Other protocol-defined inclusion/exclusion criteria may apply
About this study
Official title: A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, Non Small-Cell Lung Cancer That Has Metastasized to the Brain
The purpose of this study is to establish the intracranial efficacy of single agent capmatinib in the population of treatment-naïve or pretreated with one or two prior lines of systemic therapies for advanced stage Non Small-Cell Lung Cancer (NSCLC) with MET exon 14 mutation that has metastasized to the brain.
Cohort 1 (asymptomatic brain metastases (BM) without prior brain therapy) has been selected to identify patients who are most likely to benefit from capmatinib therapy in this setting and to establish a clinically relevant response outcome.
Cohort 2 is a heterogeneous group of patients (symptomatic with and without prior brain therapy, asymptomatic with prior brain therapy, or with leptomeningeal disease.), and the outcomes will be descriptive only
Read the detailed description
This is a prospectively designed, multicenter, open-label, two-cohort, phase II study to evaluate the intracranial efficacy of single agent capmatinib in participants with MET exon 14 mutated NSCLC and BM. Participants can be treatment naïve or pretreated with one or two prior lines of systemic therapies for advanced stage (stage IIIb - IV) NSCLC.
Approximately 60 participants will be enrolled globally and allocated to one of two cohorts:
Cohort 1 will enroll approximately 40 participants who are asymptomatic and without prior brain therapy.
Cohort 2 will enroll approximately 20 participants who are symptomatic with or without prior brain therapy or asymptomatic with prior brain therapy or with leptomeningeal disease.
All participants will be pre-screened for MET mutation and presence of BM will be documented at baseline by a radiologist/neuroradiologist.
Intracranial disease will be assessed and response to treatment will be evaluated using the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria every 8 weeks. Extracranial and whole body disease will be assessed and response to treatment will be evaluated using RECIST 1.1 every 8 weeks.
Participants will receive capmatinib 400 mg b.i.d. until they experience any of the following: documented disease progression by RANO-BM criteria and/or RECIST 1.1 (as assessed by the investigator and confirmed by BIRC), withdrawal of consent, pregnancy, lost to follow-up, or death.
For all participants, treatment with capmatinib may be continued beyond initial progression disease (PD) as per RANO-BM criteria and/or RECIST 1.1 (as assessed by the investigator and confirmed by BIRC) if, in the judgment of the investigator, there is evidence of clinical benefit, and the participant wishes to continue on the study treatment.
After treatment discontinuation, all participants will be followed for safety evaluations during the safety follow-up period, and the participant's status will be collected every 12 weeks as part of the survival follow-up.
- Conditions
- Non-small Cell Lung Carcinoma (NSCLC)
- Being tested
- Capmatinib
- Keywords
- Non-small cell lung carcinoma, Non-small cell lung cancer, NSCLC, Treatment of lung cancer after first metastasi, Lung cancer, Lung adenocarcinoma, Squamous cell lung carcinoma, Large-cell lung carcinoma, Large-cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapmatinibDrug
400 mg administered orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants who are asymptomatic and without prior brain therapy Receives: Drug: Capmatinib |
| Cohort 2 | Experimental | Participants who are symptomatic with or without prior brain therapy or asymptomatic with prior brain therapy or with leptomeningeal disease Receives: Drug: Capmatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Intracranial Response Rate (OIRR) in Cohort 1 by Blinded Independent Review Committee (BIRC) review
Overall Intracranial Response Rate (OIRR) in Cohort 1, defined as the proportion of participants with a confirmed best intracranial overall response of Complete Response (CR) or Partial Response (PR) per RANO-BM criteria as assessed by BIRC review
Measured: Up to 36 months
Secondary outcomes (23)
Overall Intracranial Response Rate (OIRR) in Cohort 1 by investigator review
Overall Intracranial Response Rate (OIRR) in Cohort 1, defined as the proportion of participants with a confirmed best intracranial overall response of Complete Response (CR) or Partial Response (PR) per RANO-BM criteria as assessed by investigator review
Measured: Up to 36 months
Intracranial Disease Control Rate (IDCR) by investigator and BIRC review
Intracranial Disease Control Rate (IDCR) per RANO-BM criteria as assessed by investigator review and by BIRC review
Measured: Up to 36 months
Time to intracranial tumor Response (TTIR) by investigator and BIRC review
Time to intracranial tumor Response (TTIR) per RANO-BM criteria as assessed by investigator review and by BIRC review
Measured: Up to 36 months
Duration of Intracranial Response (DOIR) by investigator and BIRC review
Duration of Intracranial Response (DOIR) per RANO-BM as assessed by investigator review and by BIRC review
Measured: Up to 36 months
Overall Intracranial Response Rate (OIRR) in Cohort 2 by investigator and BIRC review
Overall Intracranial Response Rate (OIRR) per RANO-BM criteria in Cohort 2 by investigator review and by BIRC review
Measured: Up to 36 months
Overall Extracranial Response Rate (OERR) by investigator and BIRC review
Overall Extracranial Response Rate (OERR) per RECIST 1.1 by investigator review and by BIRC review
Measured: Up to 36 months
Extracranial Disease Control Rate (EDCR) by investigator and BIRC review
Extracranial Disease Control Rate (EDCR) per RECIST 1.1 by investigator and BIRC review
Measured: Up to 36 months
Time to Extracranial Response (TTER) by investigator and BIRC review
Time to Extracranial Response (TTER) per RECIST 1.1 by investigator review and by BIRC review
Measured: Up to 36 months
Duration of Extracranial Response (DOER) by investigator and BIRC review
Duration of Extracranial Response (DOER) per RECIST 1.1 by investigator review and by BIRC review
Measured: Up to 36 months
Overall Response Rate (ORR) per RECIST 1.1 by investigator and BIRC review
Overall Response Rate (ORR) in the whole body per RECIST 1.1 by investigator review and by BIRC review
Measured: Up to 36 months
Time to response (TTR) by investigator and BIRC review
Time to response (TTR) in the whole body per RECIST 1.1 by investigator review and by BIRC review
Measured: Up to 36 months
Duration of response (DOR) by investigator and BIRC review
Duration of response (DOR) in the whole body per RECIST 1.1 by investigator review and by BIRC review
Measured: Up to 36 months
Progression free survival (PFS) by investigator and BIRC review
Progression free survival (PFS) in the whole body per RECIST 1.1 by investigator review and by BIRC review
Measured: Up to 36 months
Overall survival (OS)
Overall survival (OS) is defined as the time from the date of start of treatment to the date of death due to any cause.
Measured: Up to 36 months
Percentage of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety profile of capmatinib. Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) including any clinically significant lab, vital signs, ECG abnormalities that are captured as an AE
Measured: Up to 36 months
Number of participants with dose interruptions
Tolerability measured by the number of subjects who have interruptions of study treatment
Measured: Up to 29 months
Number of participants with dose reductions
Tolerability measured by the number of subjects who have reductions of study treatment
Measured: Up to 29 months
Dose intensity
Tolerability measured by the dose intensity of study drug computed as the ratio of actual cumulative dose received and actual duration of exposure
Measured: Up to 29 months
Time to deterioration in Functional Assessment of Cancer Therapy (FACT)-Brain Symptom Index (FBrSI) scores in Cohort 1
Time to deterioration in symptoms of brain metastases in Cohort 1 with the Functional Assessment of Cancer Therapy (FACT)-Brain Symptom Index (FBrSI) (a standardized questionnaire developed to assess the quality of life of cancer patients)
Measured: Day 1 and 15 of Cycle 1, Day 1 of cycles 2 to 11 and then every other cycle until end of treatment (up to 29 months). Cycle=28 days
Change from baseline in score as per FACT-Brain Symptom Index (FBrSI) in Cohort 2
Change from baseline in symptoms of brain metastases in Cohort 2 with the FACT-Brain Symptom Index (FBrSI) (a standardized questionnaire developed to assess the quality of life of cancer patients)
Measured: Day 1 and 15 of Cycle 1, Day 1 of cycles 2 to 11 and then every other cycle until end of treatment (up to 29 months). Cycle=28 days
Change from baseline in score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Change from baseline in lung cancer related symptoms, functioning and other domains of HRQoL in both cohorts with the EORTC QLQ-C30 (a 30-item questionnaire developed to assess the quality of life of cancer patients)
Measured: Day 1 of cycle 1 to 11 and then every other cycle until end of treatment (up to 29 months). Cycle=28 days
Change from baseline in score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)
Change from baseline in lung cancer related symptoms, functioning and other domains of HRQoL in both cohorts with the QLQ-LC13 (a 13-item questionnaire developed to assess the quality of life of cancer patients)
Measured: Day 1 of cycle 1 to 11 and then every other cycle until end of treatment (up to 29 months). Cycle=28 days
Change from baseline in score as per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Change from baseline in lung cancer related symptoms, functioning and other domains of HRQoL in both cohorts with the EQ-5D-5L (a standardized questionnaire developed to assess the quality of life of cancer patients)
Measured: Day 1 of cycle 1 to 11 and then every other cycle until end of treatment (up to 29 months). Cycle=28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start11 Nov 2020 (estimated)
- Primary completion17 Nov 2023 (estimated)
- Study completion17 Nov 2023 (estimated)
Why it stopped: company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Carcinoma (NSCLC)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 60 participants will be enrolled globally and allocated to one of two cohorts based on whether their metastatic brain disease is symptomatic or asymptomatic and with or without prior brain therapy or if they have been diagnosed with leptomeningeal disease
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460729
- Sponsor's protocol ID
- CINC280A2203
- Status last verified
- Nov 2020
- First submitted
- 2 Jul 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, Non Small-Cell Lung Cancer That Has Metastasized to the Brain
- ClinicalTrials.gov ID
- NCT04460729
- Acronym / sponsor ID
- CINC280A2203
- Conditions
- Non-small Cell Lung Carcinoma (NSCLC)
- Keywords
- Non-small cell lung carcinoma, Non-small cell lung cancer, NSCLC, Treatment of lung cancer after first metastasi, Lung cancer, Lung adenocarcinoma, Squamous cell lung carcinoma, Large-cell lung carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2020 (estimated)
- Primary completion
- 17 Nov 2023 (estimated)
- Study completion
- 17 Nov 2023 (estimated)
- First posted
- 8 Jul 2020 (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 purpose of this study is to establish the intracranial efficacy of single agent capmatinib in the population of treatment-naïve or pretreated with one or two prior lines of systemic therapies for advanced stage Non Small-Cell Lung Cancer (NSCLC) with MET exon 14 mutation that has metastasized to the brain.
Cohort 1 (asymptomatic brain metastases (BM) without prior brain therapy) has been selected to identify patients who are most likely to benefit from capmatinib therapy in this setting and to establish a clinically relevant response outcome.
Cohort 2 is a heterogeneous group of patients (symptomatic with and without prior brain therapy, asymptomatic with prior brain therapy, or with leptomeningeal disease.), and the outcomes will be descriptive only
Detailed description
This is a prospectively designed, multicenter, open-label, two-cohort, phase II study to evaluate the intracranial efficacy of single agent capmatinib in participants with MET exon 14 mutated NSCLC and BM. Participants can be treatment naïve or pretreated with one or two prior lines of systemic therapies for advanced stage (stage IIIb - IV) NSCLC.
Approximately 60 participants will be enrolled globally and allocated to one of two cohorts:
Cohort 1 will enroll approximately 40 participants who are asymptomatic and without prior brain therapy.
Cohort 2 will enroll approximately 20 participants who are symptomatic with or without prior brain therapy or asymptomatic with prior brain therapy or with leptomeningeal disease.
All participants will be pre-screened for MET mutation and presence of BM will be documented at baseline by a radiologist/neuroradiologist.
Intracranial disease will be assessed and response to treatment will be evaluated using the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria every 8 weeks. Extracranial and whole body disease will be assessed and response to treatment will be evaluated using RECIST 1.1 every 8 weeks.
Participants will receive capmatinib 400 mg b.i.d. until they experience any of the following: documented disease progression by RANO-BM criteria and/or RECIST 1.1 (as assessed by the investigator and confirmed by BIRC), withdrawal of consent, pregnancy, lost to follow-up, or death.
For all participants, treatment with capmatinib may be continued beyond initial progression disease (PD) as per RANO-BM criteria and/or RECIST 1.1 (as assessed by the investigator and confirmed by BIRC) if, in the judgment of the investigator, there is evidence of clinical benefit, and the participant wishes to continue on the study treatment.
After treatment discontinuation, all participants will be followed for safety evaluations during the safety follow-up period, and the participant's status will be collected every 12 weeks as part of the survival follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Approximately 60 participants will be enrolled globally and allocated to one of two cohorts based on whether their metastatic brain disease is symptomatic or asymptomatic and with or without prior brain therapy or if they have been diagnosed with leptomeningeal disease
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CapmatinibParticipants who are asymptomatic and without prior brain therapy |
| Cohort 2 | Experimental | Drug: CapmatinibParticipants who are symptomatic with or without prior brain therapy or asymptomatic with prior brain therapy or with leptomeningeal disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed stage IV (according to Version 8 of the American Joint Committee on Cancer (AJCC)) NSCLC that is EGFR wt, ALK rearrangement negative as assessed by a validated test as part of the participant's standard of care and has MET∆ex14 mutation per Novartis-designated central laboratory or (US only) locally with FoundationOne Companion Diagnostic (F1CDx) .
- Treatment naïve or up to two prior lines of systemic therapy for stage IIIb-IV NSCLC
- Measurable intracranial lesions:
- Capable of undergoing magnetic resonance imaging (MRI)
- ECOG performance status of 0 or 1
Key exclusion criteria (7 listed)
- Only for Cohort 1: any neurological symptoms related to brain metastases
- For participants in Cohort 2 with prior brain therapy: Treatment with stereotactic radiosurgery within 14 days prior to the start of study treatment or treatment with WBRT within 14 days prior to the start of study treatment
- Prior treatment with any MET targeting therapy or HGF inhibitor
- Participants with other known druggable molecular alterations (such as ROS1 translocation or BRAF mutation) who might be candidates to alternative targeted therapies as applicable per local regulations and treatment guidelines
- Presence or history of ILD or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
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 |
|---|---|---|
| Capmatinib400 mg administered orally twice daily | Drug | Cohort 1, Cohort 2 |
Primary outcome
Overall Intracranial Response Rate (OIRR) in Cohort 1 by Blinded Independent Review Committee (BIRC) review
Time frame: Up to 36 months
Overall Intracranial Response Rate (OIRR) in Cohort 1, defined as the proportion of participants with a confirmed best intracranial overall response of Complete Response (CR) or Partial Response (PR) per RANO-BM criteria as assessed by BIRC review
23 secondary outcomes
Overall Intracranial Response Rate (OIRR) in Cohort 1 by investigator review
Time frame: Up to 36 months
Intracranial Disease Control Rate (IDCR) by investigator and BIRC review
Time frame: Up to 36 months
Time to intracranial tumor Response (TTIR) by investigator and BIRC review
Time frame: Up to 36 months
Duration of Intracranial Response (DOIR) by investigator and BIRC review
Time frame: Up to 36 months
Overall Intracranial Response Rate (OIRR) in Cohort 2 by investigator and BIRC review
Time frame: Up to 36 months
Overall Extracranial Response Rate (OERR) by investigator and BIRC review
Time frame: Up to 36 months
Extracranial Disease Control Rate (EDCR) by investigator and BIRC review
Time frame: Up to 36 months
Time to Extracranial Response (TTER) by investigator and BIRC review
Time frame: Up to 36 months
Duration of Extracranial Response (DOER) by investigator and BIRC review
Time frame: Up to 36 months
Overall Response Rate (ORR) per RECIST 1.1 by investigator and BIRC review
Time frame: Up to 36 months
Time to response (TTR) by investigator and BIRC review
Time frame: Up to 36 months
Duration of response (DOR) by investigator and BIRC review
Time frame: Up to 36 months
Progression free survival (PFS) by investigator and BIRC review
Time frame: Up to 36 months
Overall survival (OS)
Time frame: Up to 36 months
Percentage of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 36 months
Number of participants with dose interruptions
Time frame: Up to 29 months
Number of participants with dose reductions
Time frame: Up to 29 months
Dose intensity
Time frame: Up to 29 months
Time to deterioration in Functional Assessment of Cancer Therapy (FACT)-Brain Symptom Index (FBrSI) scores in Cohort 1
Time frame: Day 1 and 15 of Cycle 1, Day 1 of cycles 2 to 11 and then every other cycle until end of treatment (up to 29 months). Cycle=28 days
Change from baseline in score as per FACT-Brain Symptom Index (FBrSI) in Cohort 2
Time frame: Day 1 and 15 of Cycle 1, Day 1 of cycles 2 to 11 and then every other cycle until end of treatment (up to 29 months). Cycle=28 days
Change from baseline in score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Time frame: Day 1 of cycle 1 to 11 and then every other cycle until end of treatment (up to 29 months). Cycle=28 days
Change from baseline in score as per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Lung Cancer Module (QLQ-LC13)
Time frame: Day 1 of cycle 1 to 11 and then every other cycle until end of treatment (up to 29 months). Cycle=28 days
Change from baseline in score as per European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) questionnaire
Time frame: Day 1 of cycle 1 to 11 and then every other cycle until end of treatment (up to 29 months). Cycle=28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capmatinib in people with Non-small Cell Lung Carcinoma (NSCLC), run by Novartis Pharmaceuticals.
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 7 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: withdrawn, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Intracranial Response Rate (OIRR) in Cohort 1 by Blinded Independent Review Committee (BIRC) review (time frame: Up to 36 months). 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 3 Dec 2020.