Phase 2
Completed N=18
Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT03647488 ↗Enrolled (actual)
18
Serious AEs
55.6%
Results posted
Oct 2021
Primary outcomePrimary: Run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs) — 1 Participants
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs) |
1 | — |
| PRIMARY Run-in Part: Percentage of Participants With Adverse Events (AEs) |
18; 11; 14; 1; 10; 7 | — |
| PRIMARY Run-in Part: Percentage of Participants With at Least One Dose Reduction. |
6 | — |
| PRIMARY Run-in Part: Percentage of Participants With at Least One Dose Interruption |
8; 3 | — |
| PRIMARY Run-in Part: Relative Dose Intensity Received by Participants |
99.6; 100.0 | — |
| PRIMARY Randomized Part: Overall Survival (OS) |
— | — |
| SECONDARY Objective Response Rate (ORR) Based on RECIST 1.1 and as Per Investigator Assessment |
— | — |
| SECONDARY Disease Control Rate (DCR) Based on RECIST 1.1 and as Per Investigator Assessment |
27.8 | — |
| SECONDARY Progression Free Survival (PFS) |
1.9 | — |
| SECONDARY Time to Response (TTR) Based on RECIST 1.1 and as Per Investigator Assessment |
— | — |
| SECONDARY Duration of Response (DOR) Based on RECIST 1.1 and as Per Investigator Assessment |
— | — |
| SECONDARY AUClast of Capmatinib |
11500 | — |
| SECONDARY AUCtau of Capmatinib |
12800 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Capmatinib |
3260 | — |
| SECONDARY Time to Reach Maximum (Tmax) Plasma Concentration of Capmatinib |
1.42 | — |
| SECONDARY AUClast of Spartlizumab |
1720 | — |
| SECONDARY AUCtau of Spartlizumab |
2110 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Spartlizumab |
138 | — |
| SECONDARY Time to Reach Maximum (Tmax) Plasma Concentration of Spartlizumab |
1.13 | — |
| SECONDARY Spartalizumab Antidrug Antibodies (ADA) Prevalence at Baseline |
3 | — |
| SECONDARY Spartalizumab ADA Incidence On-treatment |
3 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03647488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.