Carcinoma, Non-Small-Cell LungPhase 2NCT03647488
Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer
A Phase 2 study testing Capmatinib, Spartalizumab and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Novartis Pharmaceuticals at 8 sites in 6 countries.
Trial summary
The purpose of this trial was to evaluate the safety and efficacy of capmatinib in combination with spartalizumab in adult participants with epidermal growth factor receptor (EGFR) wild type (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangement negative in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Capmatinib, Spartalizumab and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 26 Dec 2018to 7 Sep 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 locally advanced/metastatic (stage IIIB/IV), EGFR wild-type, ALK rearrangement negative, non-small cell lung cancer
- Subject had demonstrated progression following one prior platinum doublet and one prior PD-(L)1 checkpoint inhibitor (either alone or in combination, the most recent treatment regimen must have contained a PD-(L)1 checkpoint inhibitor)
- Subjects must be candidates for single agent docetaxel
- Subjects must have at least one lesion evaluable by RECIST 1.1
Who cannot join
- Prior treatment with a MET inhibitor or HGF (Hepatocyte growth factor) targeting therapy
- Any untreated central nervous system (CNS) lesion
- Use of any live vaccines against infectious diseases within 12 weeks of initiation of study treatment.
- Other protocol-defined inclusion/exclusion criteria might apply.
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
France2 sites
Novartis Investigative Site
Grenoble, 38043
Novartis Investigative Site
Lille Cédex, 59037
Spain2 sites
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Madrid, 28009
United States1 site
Highlands Oncology Group
Fayetteville, Arkansas, 72703
About this study
Official title: Phase II Multicenter Randomized Two-arm Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Pretreated Adult Patients With EGFR Wild-type ALK Rearrangement Negative Advanced/Metastatic Non-small Cell Lung Cancer
The purpose of this trial was to evaluate the safety and efficacy of capmatinib in combination with spartalizumab in adult participants with epidermal growth factor receptor (EGFR) wild type (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangement negative in locally advanced (stage IIIB, not eligible for definitive chemo-radiation) or metastatic (stage IV) Non-small cell lung cancer (NSCLC) after failure of platinum doublet and checkpoint inhibitor treatment.
Read the detailed description
This was a two-part prospectively designed, multicenter, open-label, randomized phase II study.
Part 1: Run-in. Prior to the randomized part of the study, a run-in to assess the safety and tolerability as well as preliminary efficacy of the capmatinib and spartalizumab combination was conducted. Participants were treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days. A review was planned to take place after all participants had at least 24 weeks of follow-up. The decision to expand the study to the randomized part was to be based on the safety, tolerability, and preliminary efficacy of the capmatinib and spartalizumab combination.
Part 2: Randomized. Subjects were planned to be randomized to one of the following arms in a 2:1 ratio: 1) combination of capmatinib 400 mg BID and spartalizumab 400 mg i.v. once every 28 days; 2) docetaxel 75 mg/m2 i.v. following local guidelines as per standard of care and product labels. Based on the results obtained in the run-in part of the study, the randomized part was not opened.
For the run-in part of the study, the treatment period began on Cycle 1 Day 1 and continued in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of informed consent, pregnancy, lost to follow-up, or death irrespective of start of new anti-neoplastic therapy. After treatment discontinuation, all subjects were followed for safety evaluations during the safety follow-up period, and the subject's status was collected every 8 weeks as part of the survival follow-up
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Capmatinib, Spartalizumab, Docetaxel
- Keywords
- Non-small-cell lung carcinoma, Non-small-cell lung cancer, NSCLC, epidermal growth factor receptor wild type, EGFRwt, Anaplastic lymphoma kinase negative, ALK-, INC280, capmatinib and spartalizumab, combination therapy, docetaxel
- 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.
CapmatinibDrug
Also called INC280
Capmatinib 400 mg (tablets) orally taken twice daily
SpartalizumabDrug
Also called PDR001
Spartalizumab 400 mg via intravenous infusion once every 28 days
DocetaxelDrug
Docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Run-in part: capmatinib + spartalizumab | Experimental | Participants (enrolled in the run-in part) were treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days Receives: Drug: Capmatinib; Drug: Spartalizumab |
| Randomized part: capmatinib+spartalizumab | Experimental | Participants (enrolled in the randomized part) treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days Receives: Drug: Capmatinib; Drug: Spartalizumab |
| Randomized part: docetaxel | Active comparator | Participants (enrolled in the randomized part) treated with docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
Measured: From the day of the first dose of study medication up to 56 days
Run-in Part: Percentage of Participants With Adverse Events (AEs)
Percentage of participants with AEs, including changes from baseline in vital signs and laboratory results qualifying and reported as AEs.
AEs were assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: Death
Measured: From the day of the first dose of study medication to 150 days after the last dose of spartalizumab, or 30 days after the last dose of capmatinib (whichever is later) up to maximum duration of approximately 1.7 years
Run-in Part: Percentage of Participants With at Least One Dose Reduction.
Percentage of participants with at least one dose reduction. Dose reductions were only allowed for capmatinib
Measured: From the day of the first dose of study medication to end of treatment, assessed up to maximum duration of 68 weeks
Run-in Part: Percentage of Participants With at Least One Dose Interruption
Percentage of participants with at least one dose interruption. Dose interruptions were allowed for capmatinib and spartalizumab.
Measured: From the day of the first dose of study medication to end of treatment, assessed up to maximum duration of 68 weeks
Run-in Part: Relative Dose Intensity Received by Participants
The relative dose intensity of capmatinib and spartalizumab is computed as the ratio of dose intensity and planned dose intensity, multiplied by 100.
Measured: From the day of the first dose of study medication to end of treatment, assessed up to maximum duration of 68 weeks
Randomized Part: Overall Survival (OS)
OS is defined as the time from date of start of treatment to date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date patient alive.
Results are not available because randomized part never started.
Measured: From start of treatment to death due to any cause, assessed until the end of the study (up to a planned duration of 18 months)
Secondary outcomes (15)
Objective Response Rate (ORR) Based on RECIST 1.1 and as Per Investigator Assessment
ORR is defined as the percentage of subjects with best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and as per investigator assessment.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
ORR results for randomized part are not available because randomized part never started.
Measured: From start of treatment until end of treatment, assessed up to 68 weeks (run-in part)
Disease Control Rate (DCR) Based on RECIST 1.1 and as Per Investigator Assessment
DCR is defined as the percentage of subjects with best overall response of CR or PR or stable disease based on RECIST 1.1 and as per investigator assessment.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Stable disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression.
DCR results for randomized part are not available because randomized part never started.
Measured: From start of treatment until end of treatment, assessed up to 68 weeks (run-in part)
Progression Free Survival (PFS)
PFS is defined as the time from the date of start of treatment to the date of the first documented radiological progression or death due to any cause. For participants who had not progressed or died at the analysis cut-off date, PFS was censored at the date of the last adequate tumor evaluation date. An adequate tumour assessment is a tumour assessment with an overall response other than unknown.
Progression is defined using RECIST 1.1 and as per investigator assessment as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
PFS results for randomized part are not available because randomized part never started.
Measured: From start of treatment until the first documented radiological progression or death, whichever comes first, assessed up to 68 weeks (run-in part)
Time to Response (TTR) Based on RECIST 1.1 and as Per Investigator Assessment
TTR is defined as the time from the date of start of treatment to the first documented response of either CR or PR, which must be subsequently confirmed. TTR was evaluated according to RECIST 1.1 and as per investigator assessment.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm.
PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
For run-in part, TTR results are not available because there were no participants achieving response (CR or PR) For randomized part , TTR results are not available because randomized part never started.
Measured: From start of treatment to the first documented response of either complete response or partial response, assessed up to 68 weeks (run-in part)
Duration of Response (DOR) Based on RECIST 1.1 and as Per Investigator Assessment
DOR is the time between the date of first documented response(CR or PR) and the date of first documented progression or death due to underlying cancer based on RECIST1.1 and as per investigator assessment. If progression or death has not occurred, the subject is censored at the date of last adequate tumor assessment. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes assigned as target lesions must have a reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progression: at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. The sum must also demonstrate an absolute increase of at least 5 mm. Results are not available because there were no participants achieving response in the run-in part and randomized part never started
Measured: From first documented response (CR or PR) to first documented progression or death, whichever came first, assessed up to 68 weeks (run-in part)
AUClast of Capmatinib
AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. AUClast was calculated using non-compartmental methods.
Measured: Cycle 3 day 1 at predose, 0.5 hours (h), 1h, 2h, 4h and 8h postdose. Each Cycle is 28 days
AUCtau of Capmatinib
AUCtau is the area under the plasma concentration-time curve from time zero to the end of the dosing interval Tau. AUCtau was calculated using non-compartmental methods.
Measured: Cycle 3 day 1 at predose, 0.5 hours (h), 1h, 2h, 4h and 8h postdose. Each Cycle is 28 days
Maximum Plasma Concentration (Cmax) of Capmatinib
The maximum (peak) observed plasma concentration after single dose administration. Cmax was calculated using non-compartmental methods.
Measured: Cycle 3 day 1 at predose, 0.5 hours (h), 1h, 2h, 4h and 8h postdose. Each Cycle is 28 days
Time to Reach Maximum (Tmax) Plasma Concentration of Capmatinib
Tmax is the time to reach maximum (peak) plasma concentration of capmatinib after single dose administration (time). Tmax was calculated using non-compartmental methods.
Measured: Cycle 3 day 1 at predose, 0.5 hours (h), 1h, 2h, 4h and 8h postdose. Each Cycle is 28 days
AUClast of Spartlizumab
AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. AUClast was calculated using non-compartmental methods.
Measured: CCycle 3 day 1 at predose and 1 hour postdose (up to 1.53 hours postdose), cycle 3 day 4 (=72 hours postdose), cycle 3 day 8 (=168 hours postdose) and cycle 3 day 15 (=336 hours postdose). Each Cycle is 28 days
AUCtau of Spartlizumab
AUCtau is the area under the plasma concentration-time curve from time zero to the end of the dosing interval Tau. AUCtau was calculated using non-compartmental methods.
Measured: Cycle 3 day 1 at predose and 1 hour postdose (up to 1.53 hours postdose), cycle 3 day 4 (=72 hours postdose), cycle 3 day 8 (=168 hours postdose) and cycle 3 day 15 (=336 hours postdose). Each Cycle is 28 days
Maximum Plasma Concentration (Cmax) of Spartlizumab
The maximum (peak) observed plasma concentration after single dose administration. Cmax was calculated using non-compartmental methods.
Measured: Cycle 3 day 1 at predose and 1 hour postdose (up to 1.53 hours postdose), cycle 3 day 4 (=72 hours postdose), cycle 3 day 8 (=168 hours postdose) and cycle 3 day 15 (=336 hours postdose). Each Cycle is 28 days
Time to Reach Maximum (Tmax) Plasma Concentration of Spartlizumab
Tmax is the time to reach maximum (peak) plasma concentration of spartlizumab after single dose administration (time). Tmax was calculated using non-compartmental methods.
Measured: Cycle 3 day 1 at predose and 1 hour postdose (up to 1.53 hours postdose), cycle 3 day 4 (=72 hours postdose), cycle 3 day 8 (=168 hours postdose) and cycle 3 day 15 (=336 hours postdose). Each Cycle is 28 days
Spartalizumab Antidrug Antibodies (ADA) Prevalence at Baseline
ADA prevalence at baseline was calculated as the proportion of participants who had an ADA positive result at baseline
Measured: Cycle 1 Day 1 at predose. Each Cycle is 28 days
Spartalizumab ADA Incidence On-treatment
ADA incidence on treatment was calculated as the proportion of participants who were treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)
Measured: Predose at Cycle (C)1 Day (D)1, C2D1, C3D1, C4D1, C6D1, C8D1, C10D1, C12D1, thereafter every 6 cycles until discontinuation, and end of treatment (EOT), 30-day and 150-day after EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start26 Dec 2018
- Primary completion7 Sep 2020
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Run-in part was single group. Randomized part (parallel design) was not opened.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647488
- Sponsor's protocol ID
- CINC280D2201
- Other IDs
- 2018-001420-19, 2018
- Status last verified
- Jan 2022
- First submitted
- 20 Aug 2018
- Last updated
- 24 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Randomized Two-arm Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Pretreated Adult Patients With EGFR Wild-type ALK Rearrangement Negative Advanced/Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03647488
- Acronym / sponsor ID
- CINC280D2201
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Non-small-cell lung carcinoma, Non-small-cell lung cancer, NSCLC, epidermal growth factor receptor wild type, EGFRwt, Anaplastic lymphoma kinase negative, ALK-, INC280
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- 7 Sep 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Posted 25 Oct 2021
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 trial was to evaluate the safety and efficacy of capmatinib in combination with spartalizumab in adult participants with epidermal growth factor receptor (EGFR) wild type (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangement negative in locally advanced (stage IIIB, not eligible for definitive chemo-radiation) or metastatic (stage IV) Non-small cell lung cancer (NSCLC) after failure of platinum doublet and checkpoint inhibitor treatment.
Detailed description
This was a two-part prospectively designed, multicenter, open-label, randomized phase II study.
Part 1: Run-in. Prior to the randomized part of the study, a run-in to assess the safety and tolerability as well as preliminary efficacy of the capmatinib and spartalizumab combination was conducted. Participants were treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days. A review was planned to take place after all participants had at least 24 weeks of follow-up. The decision to expand the study to the randomized part was to be based on the safety, tolerability, and preliminary efficacy of the capmatinib and spartalizumab combination.
Part 2: Randomized. Subjects were planned to be randomized to one of the following arms in a 2:1 ratio: 1) combination of capmatinib 400 mg BID and spartalizumab 400 mg i.v. once every 28 days; 2) docetaxel 75 mg/m2 i.v. following local guidelines as per standard of care and product labels. Based on the results obtained in the run-in part of the study, the randomized part was not opened.
For the run-in part of the study, the treatment period began on Cycle 1 Day 1 and continued in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of informed consent, pregnancy, lost to follow-up, or death irrespective of start of new anti-neoplastic therapy. After treatment discontinuation, all subjects were followed for safety evaluations during the safety follow-up period, and the subject's status was collected every 8 weeks as part of the survival follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Run-in part was single group. Randomized part (parallel design) was not opened.
| Arm | Type | Receives |
|---|---|---|
| Run-in part: capmatinib + spartalizumab | Experimental | Drug: Capmatinib, Drug: SpartalizumabParticipants (enrolled in the run-in part) were treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days |
| Randomized part: capmatinib+spartalizumab | Experimental | Drug: Capmatinib, Drug: SpartalizumabParticipants (enrolled in the randomized part) treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days |
| Randomized part: docetaxel | Active comparator | Drug: DocetaxelParticipants (enrolled in the randomized part) treated with docetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed locally advanced/metastatic (stage IIIB/IV), EGFR wild-type, ALK rearrangement negative, non-small cell lung cancer
- Subject had demonstrated progression following one prior platinum doublet and one prior PD-(L)1 checkpoint inhibitor (either alone or in combination, the most recent treatment regimen must have contained a PD-(L)1 checkpoint inhibitor)
- Subjects must be candidates for single agent docetaxel
- Subjects must have at least one lesion evaluable by RECIST 1.1
Key exclusion criteria (4 listed)
- Prior treatment with a MET inhibitor or HGF (Hepatocyte growth factor) targeting therapy
- Any untreated central nervous system (CNS) lesion
- Use of any live vaccines against infectious diseases within 12 weeks of initiation of study treatment.
- Other protocol-defined inclusion/exclusion criteria might apply.
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 |
|---|---|---|
| CapmatinibAlso: INC280Capmatinib 400 mg (tablets) orally taken twice daily | Drug | Randomized part: capmatinib+spartalizumab, Run-in part: capmatinib + spartalizumab |
| SpartalizumabAlso: PDR001Spartalizumab 400 mg via intravenous infusion once every 28 days | Drug | Randomized part: capmatinib+spartalizumab, Run-in part: capmatinib + spartalizumab |
| DocetaxelDocetaxel 75mg/m2 i.v. following local guidelines as per standard of care and product labels once every 21 days | Drug | Randomized part: docetaxel |
Primary outcome
Run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs)
Time frame: From the day of the first dose of study medication up to 56 days
A DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
Run-in Part: Percentage of Participants With Adverse Events (AEs)
Time frame: From the day of the first dose of study medication to 150 days after the last dose of spartalizumab, or 30 days after the last dose of capmatinib (whichever is later) up to maximum duration of approximately 1.7 years
Percentage of participants with AEs, including changes from baseline in vital signs and laboratory results qualifying and reported as AEs. AEs were assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: Death
Run-in Part: Percentage of Participants With at Least One Dose Reduction.
Time frame: From the day of the first dose of study medication to end of treatment, assessed up to maximum duration of 68 weeks
Percentage of participants with at least one dose reduction. Dose reductions were only allowed for capmatinib
Run-in Part: Percentage of Participants With at Least One Dose Interruption
Time frame: From the day of the first dose of study medication to end of treatment, assessed up to maximum duration of 68 weeks
Percentage of participants with at least one dose interruption. Dose interruptions were allowed for capmatinib and spartalizumab.
Run-in Part: Relative Dose Intensity Received by Participants
Time frame: From the day of the first dose of study medication to end of treatment, assessed up to maximum duration of 68 weeks
The relative dose intensity of capmatinib and spartalizumab is computed as the ratio of dose intensity and planned dose intensity, multiplied by 100.
Randomized Part: Overall Survival (OS)
Time frame: From start of treatment to death due to any cause, assessed until the end of the study (up to a planned duration of 18 months)
OS is defined as the time from date of start of treatment to date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date patient alive. Results are not available because randomized part never started.
15 secondary outcomes
Objective Response Rate (ORR) Based on RECIST 1.1 and as Per Investigator Assessment
Time frame: From start of treatment until end of treatment, assessed up to 68 weeks (run-in part)
Disease Control Rate (DCR) Based on RECIST 1.1 and as Per Investigator Assessment
Time frame: From start of treatment until end of treatment, assessed up to 68 weeks (run-in part)
Progression Free Survival (PFS)
Time frame: From start of treatment until the first documented radiological progression or death, whichever comes first, assessed up to 68 weeks (run-in part)
Time to Response (TTR) Based on RECIST 1.1 and as Per Investigator Assessment
Time frame: From start of treatment to the first documented response of either complete response or partial response, assessed up to 68 weeks (run-in part)
Duration of Response (DOR) Based on RECIST 1.1 and as Per Investigator Assessment
Time frame: From first documented response (CR or PR) to first documented progression or death, whichever came first, assessed up to 68 weeks (run-in part)
AUClast of Capmatinib
Time frame: Cycle 3 day 1 at predose, 0.5 hours (h), 1h, 2h, 4h and 8h postdose. Each Cycle is 28 days
AUCtau of Capmatinib
Time frame: Cycle 3 day 1 at predose, 0.5 hours (h), 1h, 2h, 4h and 8h postdose. Each Cycle is 28 days
Maximum Plasma Concentration (Cmax) of Capmatinib
Time frame: Cycle 3 day 1 at predose, 0.5 hours (h), 1h, 2h, 4h and 8h postdose. Each Cycle is 28 days
Time to Reach Maximum (Tmax) Plasma Concentration of Capmatinib
Time frame: Cycle 3 day 1 at predose, 0.5 hours (h), 1h, 2h, 4h and 8h postdose. Each Cycle is 28 days
AUClast of Spartlizumab
Time frame: CCycle 3 day 1 at predose and 1 hour postdose (up to 1.53 hours postdose), cycle 3 day 4 (=72 hours postdose), cycle 3 day 8 (=168 hours postdose) and cycle 3 day 15 (=336 hours postdose). Each Cycle is 28 days
AUCtau of Spartlizumab
Time frame: Cycle 3 day 1 at predose and 1 hour postdose (up to 1.53 hours postdose), cycle 3 day 4 (=72 hours postdose), cycle 3 day 8 (=168 hours postdose) and cycle 3 day 15 (=336 hours postdose). Each Cycle is 28 days
Maximum Plasma Concentration (Cmax) of Spartlizumab
Time frame: Cycle 3 day 1 at predose and 1 hour postdose (up to 1.53 hours postdose), cycle 3 day 4 (=72 hours postdose), cycle 3 day 8 (=168 hours postdose) and cycle 3 day 15 (=336 hours postdose). Each Cycle is 28 days
Time to Reach Maximum (Tmax) Plasma Concentration of Spartlizumab
Time frame: Cycle 3 day 1 at predose and 1 hour postdose (up to 1.53 hours postdose), cycle 3 day 4 (=72 hours postdose), cycle 3 day 8 (=168 hours postdose) and cycle 3 day 15 (=336 hours postdose). Each Cycle is 28 days
Spartalizumab Antidrug Antibodies (ADA) Prevalence at Baseline
Time frame: Cycle 1 Day 1 at predose. Each Cycle is 28 days
Spartalizumab ADA Incidence On-treatment
Time frame: Predose at Cycle (C)1 Day (D)1, C2D1, C3D1, C4D1, C6D1, C8D1, C10D1, C12D1, thereafter every 6 cycles until discontinuation, and end of treatment (EOT), 30-day and 150-day after EOT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Plain language trial summaries are available on this linkLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capmatinib, Spartalizumab and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Novartis Pharmaceuticals at 8 sites in 6 countries.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Spain, United States, Belgium, Germany and 1 more country. 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 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?
Yes. Results are posted in the registry (first posted 25 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs) (time frame: From the day of the first dose of study medication up to 56 days). The study lists 6 primary outcomes in all. 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 Jan 2022.