Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreat… (NCT03158129) | Clinical Trial Compass
CompletedPhase 2
Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreated Stage I-IIIA Non-small Cell Lung Cancer
United States101 participantsStarted 2017-06-16
Plain-language summary
This phase II trial studies how well nivolumab works when given alone and in combination with ipilimumab or chemotherapy in treating patients with previously untreated stage I-IIIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, docetaxel, and pemetrexed, 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. Giving nivolumab with ipilimumab or chemotherapy may work better in treating patients with non-small cell lung cancer compared to chemotherapy alone.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed previously untreated non-small cell lung cancer. If a diagnostic biopsy is available, a pre-treatment biopsy is not required. 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
* Patients with stage IA or stage IB \< 4 cm (according to American Joint Committee on Cancer \[AJCC\] 7th edition) are eligible for randomization into arms A and B only. Patients with stage IB \>= 4 cm, IIA, IIB, or IIIA disease (according to AJCC 7th edition) are eligible for randomization into arms A, and B, and for enrollment into arms C and D
* 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
* Signed and dated written informed consent must be provided by the patient prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation
* Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
* Hemoglobin \>= 8.0 g/dL
* Platelets \>= 100 x 10\^9/L
*…
What they're measuring
1
Major Pathologic Response (mPR)
Timeframe: The lung resection specimen was collected at surgery.