Cisplatin, Docetaxel, and Nintedanib Before Surgery in Treating Patients With Previously Untreate… (NCT02225405) | Clinical Trial Compass
CompletedPhase 1
Cisplatin, Docetaxel, and Nintedanib Before Surgery in Treating Patients With Previously Untreated Stage IB-IIIA Non-small Cell Lung Cancer
United States26 participantsStarted 2015-04-03
Plain-language summary
This phase I trial studies the side effects and best dose of nintedanib when given together with cisplatin and docetaxel and to see how well they work in treating patients with previously untreated stage IB-IIIA non-small cell lung cancer who are undergoing surgery. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cisplatin, docetaxel, and nintedanib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed non-small cell lung cancer; patients with a suspected lung cancer are eligible, but pathology must be confirmed prior to initiating treatment on study; neuroendocrine carcinomas are not eligible; carcinomas with neuroendocrine differentiation are eligible
* Stage IB (with a primary tumor \>= 4 cm), IIA, IIB, or IIIA (according to American Joint Committee on Cancer \[AJCC\] 7th edition); patients with stage IIIA must not have more than one mediastinal lymph node station involved by tumor
* All patients must have lymph node evaluation of contralateral stations 2 and/or 4 to exclude N3 disease
* The patient must be a suitable candidate for surgery, in the opinion of the treating physician
* Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
* Signed and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)-Good Clinical Practice (GCP) guidelines and to the local legislation
Exclusion Criteria:
* Prior systemic therapy or radiation therapy for treatment of the current lung cancer
* Known hypersensitivity to the trial drugs or to their excipients
* Centrally located tumors with radiographic evidence (CT or magnetic resonance imaging \[MRI\]) of local invasion of major blood vessels
* Major injuries within the past 10 days prior to start of study …
What they're measuring
1
Maximum tolerated dose (MTD) of nintedanib
Timeframe: 21 days
2
Major pathologic response rate, defined as less than or equal to 10% viable tumor cells in the resected specimen using the methods described by Pataer