Trial record 1 of 1 for:
NCT04139317
Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04139317 |
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Recruitment Status :
Terminated
(Sponsor decision to terminate due to the lack of tolerability observed in patients treated with capmatinib and pembrolizumab in the combination arm as compared to patients treated with pembrolizumab alone in the pembrolizumab single agent arm)
First Posted : October 25, 2019
Last Update Posted : February 27, 2023
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
The purpose is 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Drug: Capmatinib Biological: Pembrolizumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 76 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Open Label, Multicenter Phase II Study Evaluating the Efficacy and Safety of Capmatinib (INC280) Plus Pembrolizumab Versus Pembrolizumab Alone as First Line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer With PD-L1≥ 50% |
| Actual Study Start Date : | January 22, 2020 |
| Actual Primary Completion Date : | January 14, 2022 |
| Actual Study Completion Date : | February 7, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Combination arm
Capmatinib 400 mg twice a day Pembrolizumab 200mg every 3 weeks
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Drug: Capmatinib
Oral tablet
Other Name: INC280 Biological: Pembrolizumab IV infusion
Other Names:
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Active Comparator: monotherapy
Pembrolizumab 200mg every 3 weeks
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Biological: Pembrolizumab
IV infusion
Other Names:
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Primary Outcome Measures :
- Progression-free survival (PFS) based on local investigator assessment as per RECIST 1.1 [ Time Frame: 18 months ]Progression free survival is defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1(Response evaluation criteria in solid tumor) or death due to any cause
Secondary Outcome Measures :
- Objective response rate (ORR) based on local investigator assessment as per RECIST 1.1 [ Time Frame: 18 months ]ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1
- Disease control rate (DCR) based on local investigator assessment as per RECIST 1.1 [ Time Frame: 18 months ]Disease control rate is defined as the proportion of patients with complete response (CR) or partial response (PR) or subjects with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria
- Time-to-response (TTR) based on local investigator assessment as per RECIST 1.1 [ Time Frame: 18 months ]Time to response (TTR) is defined as duration of time between the date of randomization and the date of first documented response of either CR or PR, according to RECIST 1.1 criteria
- Duration of response (DOR) based on local investigator assessment as per RECIST 1.1 [ Time Frame: 18 months ]Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria
- Overall survival (OS) [ Time Frame: 18 months ]Overall survival is defined as the time from date of randomization to date of death due to any cause
- Antidrug antibodies (ADA) of pembrolizumab [ Time Frame: 13 months ]Concentration/presence of ADA to be measured
- AUC of capmatinib derived from plasma capmatinib concentration [ Time Frame: 13 months ]AUC of capmatinib is defined as area under the plasma concentration-time curve determined using non-compartmental methods.
- Ctrough of pembrolizumab derived from serum pembrolizumab concentration [ Time Frame: 13 months ]Ctrough of pembrolizumab is defined as the measured serum concentration at the end of a dosing interval at steady state
- Cmax of capmatinib derived from plasma capmatinib concentration [ Time Frame: 13 months ]Cmax of capmatinib is defined as the maximum observed plasma concentration after single dose administration
- Tmax of capmatinib derived from plasma capmatinib concentration [ Time Frame: 13 months ]Tmax of capmatinib is defined as the time to reach maximum plasma concentration after single dose administration
- Incidence of adverse events [ Time Frame: 19 months ]Incidence of adverse events is defined as number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs leading to dose interruption, dose reduction and dose discontinuation.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed and documented locally advanced stage III (not candidates for surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per AJCC/IASLC v.8) for treatment in the first-line setting
- Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild type status and ALK- negative rearrangement statu
- Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1 expression (TPS ≥ 50%)
- ECOG performance status score ≤ 1
- Have at least 1 measurable lesion by RECIST 1.1
- Have adequate organ function
Exclusion Criteria:
- Prior treatment with a MET inhibitor or HGF-targeting therapy
- Prior immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
- Have untreated symptomatic central nervous system (CNS) metastases
- Clinically significant, uncontrolled heart diseases
- Prior palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting study treatment
Other protocol-defined inclusion/exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139317
Locations
| Australia, New South Wales | |
| Novartis Investigative Site | |
| Wollongong, New South Wales, Australia, 2500 | |
| Australia, South Australia | |
| Novartis Investigative Site | |
| North Adelaide, South Australia, Australia, 5006 | |
| Australia, Victoria | |
| Novartis Investigative Site | |
| Shepparton, Victoria, Australia, 3630 | |
| Belgium | |
| Novartis Investigative Site | |
| Bruxelles, Belgium, 1000 | |
| Novartis Investigative Site | |
| Liege, Belgium, 4000 | |
| Novartis Investigative Site | |
| Yvoir, Belgium, 5530 | |
| Canada | |
| Novartis Investigative Site | |
| Quebec, Canada, GIV 4G5 | |
| Czechia | |
| Novartis Investigative Site | |
| Ostrava Vitkovice, Czechia, 703 84 | |
| France | |
| Novartis Investigative Site | |
| Lille, France, 59000 | |
| Novartis Investigative Site | |
| Strasbourg Cedex, France, 67091 | |
| Novartis Investigative Site | |
| Toulouse, France, 31400 | |
| Germany | |
| Novartis Investigative Site | |
| Berlin, Germany, 14165 | |
| Novartis Investigative Site | |
| Koeln, Germany, 50937 | |
| Greece | |
| Novartis Investigative Site | |
| Athens, Greece, 11526 | |
| Novartis Investigative Site | |
| Thessaloniki, Greece, 57001 | |
| Hong Kong | |
| Novartis Investigative Site | |
| Shatin, New Territories, Hong Kong | |
| India | |
| Novartis Investigative Site | |
| Mumbai, Maharashtra, India, 401107 | |
| Novartis Investigative Site | |
| Kolkata, West Bengal, India, 700160 | |
| Novartis Investigative Site | |
| Delhi, India, 110 085 | |
| Italy | |
| Novartis Investigative Site | |
| Ancona, AN, Italy, 60126 | |
| Novartis Investigative Site | |
| Aviano, PN, Italy, 33081 | |
| Japan | |
| Novartis Investigative Site | |
| Nagoya, Aichi, Japan, 466 8560 | |
| Novartis Investigative Site | |
| Yokohama-city, Kanagawa, Japan, 236 0051 | |
| Malaysia | |
| Novartis Investigative Site | |
| Kuching, Sarawak, Malaysia, 93586 | |
| Novartis Investigative Site | |
| Kuala Lumpur, Malaysia, 59100 | |
| Netherlands | |
| Novartis Investigative Site | |
| Amersfoort, Netherlands, 3813 TZ | |
| Novartis Investigative Site | |
| Breda, Netherlands, 4819 EV | |
| Novartis Investigative Site | |
| Zwolle, Netherlands, 8025 AB | |
| Spain | |
| Novartis Investigative Site | |
| Badalona, Catalunya, Spain, 08916 | |
| Novartis Investigative Site | |
| Barcelona, Catalunya, Spain, 08035 | |
| Novartis Investigative Site | |
| Valencia, Comunidad Valenciana, Spain, 46010 | |
| Novartis Investigative Site | |
| Barcelona, Spain, 08041 | |
| Novartis Investigative Site | |
| Madrid, Spain, 28040 | |
| Taiwan | |
| Novartis Investigative Site | |
| Changhua, Taiwan, 50006 | |
| Novartis Investigative Site | |
| Taichung, Taiwan, 40705 | |
| Thailand | |
| Novartis Investigative Site | |
| Bangkok, Thailand, 10330 | |
| Novartis Investigative Site | |
| Bangkok, Thailand, 10400 | |
| Novartis Investigative Site | |
| Bangkok, Thailand, 10700 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04139317 |
| Other Study ID Numbers: |
CINC280I12201 |
| First Posted: | October 25, 2019 Key Record Dates |
| Last Update Posted: | February 27, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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capmatinib, pembrolizumab, NSCLC, PD-L1, EGFR, ALK, MET, squamous, non-squamous |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |