Not provided
Not provided
Not provided
Not provided
Not provided
Slow accrual
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Chemotherapy and Nivolumab and Surgery | Experimental | Patients with lung cancer receiving combination therapy with surgery |
|
| Combination Chemotherapy and Nivolumab and Radiation | Experimental | Patients with lung cancer receiving combination therapy with radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab and Chemotherapy | Combination Product | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate After Induction | post induction radiographic response by cat scan | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, up to 18 months |
| Percent of Participants Receiving Surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ralph Zinner, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Combination Chemotherapy and Nivolumab and Surgery | Patients with lung cancer receiving combination therapy with surgery Nivolumab and Chemotherapy: 3 cycles of 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) administered then CT + 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 Nivolumab: Participants receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation Post Induction Surgery: Induction Chemo-NIVO x 3 cycles then CT + biopsy, followed by surgery in patients with unresectable stage IIIA-C tumors at baseline on the basis of lymphadenopathy and determined to be resectable after responding to induction chemotherapy-nivolumab. participants have an option for post op XRT, then NIVO at 480 mg IV every 4 weeks for 12 cycles Post Induction XRT: 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. Participants then receive NIVO at 480 mg IV every 4 weeks for 12 cycles. |
| FG001 | Combination Chemotherapy and Nivolumab and Radiation | Patients with lung cancer receiving combination therapy with radiation Nivolumab and Chemotherapy: 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 Nivolumab: Participants will receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation Post Induction XRT: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
he study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Combination Chemotherapy and Nivolumab and Surgery | Patients with lung cancer receiving combination therapy with surgery Nivolumab and Chemotherapy: 3 cycles of 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) administered then CT + 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 Nivolumab: Participants receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation Post Induction Surgery: Induction Chemo-NIVO x 3 cycles then CT + biopsy, followed by surgery in patients with unresectable stage IIIA-C tumors at baseline on the basis of lymphadenopathy and determined to be resectable after responding to induction chemotherapy-nivolumab. participants have an option for post op XRT, then NIVO at 480 mg IV every 4 weeks for 12 cycles Post Induction XRT: 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. Participants then receive NIVO at 480 mg IV every 4 weeks for 12 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rate After Induction | post induction radiographic response by cat scan | he study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | 9 weeks |
|
The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combination Chemotherapy and Nivolumab and Surgery | Patients with lung cancer receiving combination therapy with surgery Nivolumab and Chemotherapy: 3 cycles of 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) administered then CT + 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 Nivolumab: Participants receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation Post Induction Surgery: Induction Chemo-NIVO x 3 cycles then CT + biopsy, followed by surgery in patients with unresectable stage IIIA-C tumors at baseline on the basis of lymphadenopathy and determined to be resectable after responding to induction chemotherapy-nivolumab. participants have an option for post op XRT, then NIVO at 480 mg IV every 4 weeks for 12 cycles Post Induction XRT: 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. Participants then receive NIVO at 480 mg IV every 4 weeks for 12 cycles. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ralph Zinner | University of Kentucky | 859-562-2864 | ralph.zinner@uky.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2024 | Apr 3, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Chemo, biopsy, surgery with option for post op chemo or no surgery with concurrent chemo
Not provided
Not provided
Not provided
Not provided
|
| Nivolumab | Drug | Participants will receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation |
|
|
| Post Induction Surgery | Procedure | 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 |
|
| Post Induction XRT | Radiation | 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. |
|
Rate of converting non-surgical stage III(A-C) to surgically resectable disease |
| 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 | 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 | 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. | 2 years |
| Overall Survival (OS) | defined as the duration of time from start of treatment to time of death | 2 years |
| Change in Patient-reported Quality of Life as Measured by FACT-TOI | 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). | through study completion, up to 18 months |
| BG001 | Combination Chemotherapy and Nivolumab and Radiation | Patients with lung cancer receiving combination therapy with radiation Nivolumab and Chemotherapy: 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 Nivolumab: Participants will receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation Post Induction XRT: 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. |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
| OG001 | Combination Chemotherapy and Nivolumab and Radiation | Patients with lung cancer receiving combination therapy with radiation Nivolumab and Chemotherapy: 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 Nivolumab: Participants will receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation Post Induction XRT: 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. |
|
| Secondary | 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. | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | through study completion, up to 18 months |
|
|
| Secondary | Percent of Participants Receiving Surgery | Rate of converting non-surgical stage III(A-C) to surgically resectable disease | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | date of surgery, approximately 10 weeks |
|
|
| Secondary | Pathologic Complete Response (pCR) | Number of participants with Pathologic Complete Response. Pathologic complete response (pCR) is defined by a surgical pathology specimen | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | post surgery, approximately 10 weeks |
|
|
| Secondary | Major Pathological Response (MPR) | MPR rate, defined as number of participants with ≤ 10% residual tumor in lung and lymph nodes | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | post surgery, approximately 10 weeks |
|
|
| Secondary | 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. | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | 2 years |
|
|
| Secondary | Overall Survival (OS) | defined as the duration of time from start of treatment to time of death | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | 2 years |
|
|
| Secondary | Change in Patient-reported Quality of Life as Measured by FACT-TOI | 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). | The study was terminated. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | through study completion, up to 18 months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Combination Chemotherapy and Nivolumab and Radiation | Patients with lung cancer receiving combination therapy with radiation Nivolumab and Chemotherapy: 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 Nivolumab: Participants will receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation Post Induction XRT: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| 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 |
| D013812 | Therapeutics |