18 and older, any sex, with Non-small Cell Lung Cancer (NSCLC). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-Free Survival (PFS) by Investigator Assessment as Per RECIST 1.1Primary· Up to 1.3 years
PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. Tumor response was based on investigator assessment per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment, the start of a subsequent anti-neoplastic therapy (if any) or the date of sponsor's decision to discontinue capmatinib (applicable only to subjects on the combination arm).
Due to the discontinuation of one of the investigational drugs (capmatin
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
5.2
2.0 – NA
Pembrolizumab 200mg Q3W
5.1
2.6 – NA
Overall Response Rate (ORR) by Investigator Assessment as Per RECIST 1.1Secondary· Up to 1.3 years
Tumor response was based on local investigator assessment as RECIST v1.1. ORR per RECIST v1.1 is defined as the percentage of participants with a best overall response (BOR) of Complete Response (CR) or Partial Response (PR). For the capmatinib plus pembrolizumab arm, 21-Jan-2021 or any last adequate tumor assessment prior to that date was considered as the end of evaluation period for BOR.
For RECIST v1.1, 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% d
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
9.8
3.3 – 21.4
Pembrolizumab 200mg Q3W
40.0
21.1 – 61.3
Disease Control Rate (DCR) by Investigator Assessment as Per RECIST 1.1Secondary· Up to 1.3 years
Tumor response was based on local investigator assessment per RECIST v1.1. DCR is defined as the percentage of participants with a BOR of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and non-CR/non-progressive disease (for subjects without target lesions). For the capmatinib plus pembrolizumab arm, 21-Jan-2021 or any last adequate tumor assessment prior to that date was considered as the end of evaluation period for BOR.
For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a red
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
37.3
24.1 – 51.9
Pembrolizumab 200mg Q3W
60.0
38.7 – 78.9
Time to Response (TTR) by Investigator Assessment as Per RECIST 1.1Secondary· Up to 1.3 years
TTR is defined as the time from the date of randomization to the first documented response of either complete response or partial response, which must be subsequently confirmed (although initial date of response is used, not date of confirmation).
TTR was analyzed using the Kaplan-Meier method as defined in the statistical analysis plan.
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
NA
NA – NA
Pembrolizumab 200mg Q3W
NA
NA – NA
Duration of Response (DOR) by Investigator Assessment as Per RECIST 1.1Secondary· Up to 1.3 years
DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment of overall lesion response according to RECIST v1.1. DOR is defined as the time from the date of first documented response (confirmed CR or confirmed PR) to the date of first documented disease progression or death due to any cause. If a patient not had an event, duration was censored at the date of last adequate tumor assessment before the start of a new anticancer therapy, if any.
DOR was analyzed using the Kaplan-Meier method as defined in th
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
NA
NA – NA
Pembrolizumab 200mg Q3W
NA
NA – NA
Overall Survival (OS)Secondary· Up to 2.1 years
OS is defined as the time from the date of randomization to the date of death due to any cause.
The requirement for survival follow-up period was removed following the discontinuation of one of the investigational drugs (capmatinib) in all subjects in the combination arm and the implementation of Protocol Amendment 03.
OS was analyzed using the Kaplan-Meier method as defined in the statistical analysis plan.
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
NA
NA – NA
Pembrolizumab 200mg Q3W
NA
NA – NA
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Secondary· From first dose of study treatment to 30 days after last dose, up to 2.1 years
Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.
AEs
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
49
Pembrolizumab 200mg Q3W
25
Treatment-related AEs
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
45
Pembrolizumab 200mg Q3W
18
SAEs
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
31
Pembrolizumab 200mg Q3W
13
Treatment-related SAEs
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
18
Pembrolizumab 200mg Q3W
1
AEs leading to discontinuation
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
18
Pembrolizumab 200mg Q3W
5
Treatment-related AEs leading to discontinuation
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
17
Pembrolizumab 200mg Q3W
2
AEs leading to dose reduction/interruption
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
34
Pembrolizumab 200mg Q3W
7
Treatment-related AEs leading to dose reduction/interruption
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
24
Pembrolizumab 200mg Q3W
2
Maximum Observed Plasma Concentration (Cmax) of CapmatinibSecondary· pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days.
Pharmacokinetic (PK) parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
2730
± 155.9
Time to Reach Maximum Plasma Concentration (Tmax) of CapmatinibSecondary· pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days.
PK parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
1.33
0 – 4.00
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of CapmatinibSecondary· pre-dose and 1, 2, 4 and 8 hours after morning dose on Cycle 2 Day 1. The duration of one cycle was 21 days.
PK parameters were calculated based on capmatinib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
4210
± 232.8
Trough Serum Concentration (Ctrough) of PembrolizumabSecondary· pre-dose on Cycle 2 Day 1, Cycle 3 Day 1, Cycle 6 Day 1 and Cycle 12 Day 1. The duration of one cycle was 21 days.
PK parameters were calculated based on pembrolizumab serum concentrations by using non-compartmental methods. Ctrough is defined as the concentration reached immediately before the next dose is administered. All drug concentrations below the lower limit of quantification were treated as zero for the calculation of PK parameters.
Cycle 2 Day 1
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
11.8
± 37.5
Pembrolizumab 200mg Q3W
10.6
± 34.8
Cycle 3 Day 1
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
18.9
± 51.9
Pembrolizumab 200mg Q3W
18.2
± 32.3
Cycle 6 Day 1
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
27.6
± 66.5
Pembrolizumab 200mg Q3W
36.8
± 26.0
Cycle 12 Day 1
Group
Value
95% CI
Pembrolizumab 200mg Q3W
49.7
± 10.0
Number of Participants With Anti-pembrolizumab AntibodiesSecondary· Baseline (pre-dose), up to 8 months
Immunogenicity (IG) was evaluated in serum samples. The assay to quantify and assess the IG was a validated homogeneous enzyme-linked immunosorbent assay (ELISA).
* ADA-negative at baseline: ADA-negative sample at baseline
* ADA-positive at baseline: ADA-positive sample at baseline
* ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline determinant sample, all of which are ADA-negative samples
* ADA-positive post-baseline: patient with at least 1 ADA-positive sample post baseline
ADA-negative at baseline
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
37
Pembrolizumab 200mg Q3W
18
ADA-positive at baseline
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
5
Pembrolizumab 200mg Q3W
2
ADA-negative post-baseline
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
36
Pembrolizumab 200mg Q3W
18
ADA-positive post-baseline
Group
Value
95% CI
Capmatinib 400mg BID + Pembrolizumab 200mg Q3W
6
Pembrolizumab 200mg Q3W
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from first dose of study treatment to 30 days after last dose, up to 2.1 years after start of treatment. Deaths were collected in the post-treatment survival follow-up from day 31 after last dose of study treatment until the requirement for survival follow-up was removed following the discontinuation of capmatinib in the combination arm (protocol amendment 03), up to 1.3 years after start of treatment. These are not considered AEs..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Capmatinib + Pembrolizumab - On-treatment
Serious: 26/51 (51%)
Deaths: 8/51
Pembrolizumab After Combination Treatment - On-treatment
The purpose was to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET dysregulation. The combination of capmatinib with checkpoint inhibitors has been established to be tolerable and could provide additional clinical benefit to the subjects.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06054191 — Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations
· Phase 2
· not yet recruiting
NCT05703516 — A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
· recruiting
NCT05642572 — Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A L
· Phase 2
· recruiting
NCT05488314 — A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
· Phase 1, PHASE2
· active not recruiting
NCT05243641 — Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients W
· Phase 1, PHASE2
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 9 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04139317.