Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:December 26, 2018
End Date:December 22, 2021
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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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

This is a clinical research study and the purpose of the study is to learn whether the
combination of the drugs capmatinib plus spartalizumab helps to control lung cancer better
compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to
patients with NSCLC.

Capmatinib is an oral drug that is called a "targeted" medicine: this means it targets
particular processes, which may not be working properly in the cancer cells in your body
(called dysregulation) and which may be causing your disease.

Spartalizumab is an antibody (a kind of protein that binds to a specific "target" protein).
By blocking its "target" protein, called PD-1, spartalizumab may increase the activity of a
certain type of cells in your immune system, which may reduce the growth of your tumor.

Docetaxel is a standard chemotherapy medicine commonly used to treat your type of lung
cancer. This standard, anti-cancer medicine is a cytotoxic chemotherapy that is being
compared with capmatinib and spartalizumab.

The reason for this study is to find out which of these two treatments (combination of
capmatinib plus spartalizumab OR docetaxel alone) helps to control lung cancer better.


Inclusion Criteria:

- Histologically confirmed locally advanced/metastatic (stage IIIB/IV), EGFR wild-type,
ALK rearrangement negative, non-small cell lung cancer

- Subject has 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 may apply.
We found this trial at
3
sites
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Jhanelle Gray
Phone: 888-663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Fayetteville, Arkansas 72703
Principal Investigator: Eric S Schaefer
Phone: 479-587-1700
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