The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
3 cycles of the proposed nivolumab + platinum doublet (either pemetrexed + carbo/cis or paclitaxel + carbo or docetaxel + carbo/cis for non squamous; or gemcitabine + carbo/cis or paclitaxel + carbo or docetaxel + carbo/cis for squamous) will be administered then CT and biopsy, followed by surgery with option for post-op NIVO-XRT, then 12 cycles NIVO at 480 mg IV every 4 weeks for 12 weeks
Participants will receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation
Induction Chemo-NIVO x 3 cycles then CT and biopsy, followed by surgery in patients whose tumors were unresectable stage IIIA-C at baseline on the basis of lymphadenopathy and are determined to be resectable after responding to induction chemotherapy-nivolumab. The participants have an option for post op XRT, then will receive NIVO at 480 mg IV every 4 weeks for 12 cycles
University of Kentucky
Lexington, Kentucky, United States
Response Rate After Induction
post induction radiographic response by cat scan
Time frame: 9 weeks
Change in Toxicity
To assess safety, investigators will evaluate the rate of toxicity as defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) scoring system.
Time frame: through study completion, up to 18 months
Percent of Participants Receiving Surgery
Rate of converting non-surgical stage III(A-C) to surgically resectable disease
Time frame: date of surgery, approximately 10 weeks
Pathologic Complete Response (pCR)
Number of participants with Pathologic Complete Response. Pathologic complete response (pCR) is defined by a surgical pathology specimen
Time frame: post surgery, approximately 10 weeks
Major Pathological Response (MPR)
MPR rate, defined as number of participants with ≤ 10% residual tumor in lung and lymph nodes
Time frame: post surgery, approximately 10 weeks
Progression Free Survival (PFS)
PFS is defined as the duration of time from start of treatment to time of disease progression or death, whichever occurs first.
Time frame: 2 years
Overall Survival (OS)
defined as the duration of time from start of treatment to time of death
Time frame: 2 years
Change in Patient-reported Quality of Life as Measured by FACT-TOI
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Induction Chemo-NIVO x 3 cycles then CT and biopsy, followed by concurrent Chemo and Nivo XRT (60Gy). Participants will receive concurrent thoracic radiation therapy using a standardized 3DCRT or IMRT technique on a linear accelerator operating at 2:6 MV beam energy. The target total dose of thoracic radiation therapy will be 60 Gy in 30 daily fractions of 2 Gy prescribed to the PTV. The participants then will receive NIVO at 480 mg IV every 4 weeks for 12 cycles.
patient-reported Quality of Life as measured by FACT-TOI (Functional Assessment of Cancer Therapy - Trial Outcome Index); defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS (lung cancer scale) scores obtained from 7-item questionnaires from the FACT-L (Version 4.0). Questions are on a 5-point scale from 0-4, where 0 = "not at all" and 4 = "very much." Scores range from 0 to 84; higher score indicates better physical aspects of quality of life (QoL).
Time frame: through study completion, up to 18 months