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This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemoimmunotherapy followed by radiotherapy | Experimental | Nivolumab (Opdivo) + plus platinum-doublet chemotherapy followed by radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Carboplatin, paclitaxel, and nivolumab for three cycles (for squamous cell lung cancer) or Carboplatin, pemetrexed, and nivolumab for three cycles (for lung adenocarcinoma) Followed by radiotherapy (60 Gy in 30 fractions) Followed by adjuvant nivolumab (six cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Defined as the time from start of treatment to radiographic/clinical progression (per irRECIST1.1), or death from any cause, whichever occurs first. | Approximately two years after enrollment |
| Treatment Tolerance | Proportion of patients able to complete prescribed treatment course (all planned cycles of systemic therapy and all fractions of radiotherapy). | Approximately three years after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Frequency of adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria 5.0 classified by body system, grade, and attribution. | Approximately two years after enrollment |
| Best overall response rate (BOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nithya Ramnath, MD | Contact | (734) 769-7100 | nithya.ramnath@va.gov | |
| Garth W Strohbehn, MD MSc | Contact | (734) 769-7100 | 55061 | garth.strohbehn@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Nithya Ramnath, MD | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Recruiting | West Haven | Connecticut | 06516-2770 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Carboplatin, paclitaxel, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for squamous cell lung cancer) OR Carboplatin, pemetrexed, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for lung adenocarcinoma)
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Defined as the proportion of participants who achieve a confirmed either a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by central review.
| Approximately two years after enrollment |
| Overall survival | Defined as the time from start of treatment to the date of death from any cause.. | Approximately two years after enrollment |
| VA Central Office, Washington, DC | Recruiting | Washington D.C. | District of Columbia | 20420-0001 | United States |
|
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Recruiting | Indianapolis | Indiana | 46202-2884 | United States |
|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Recruiting | Ann Arbor | Michigan | 48105-2303 | United States |
|
| Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE | Recruiting | Omaha | Nebraska | 68105-1850 | United States |
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| Michael E. DeBakey VA Medical Center, Houston, TX | Recruiting | Houston | Texas | 77030-4211 | United States |
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| Richmond VA Medical Center, Richmond, VA | Recruiting | Richmond | Virginia | 23249-0001 | United States |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |