SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02766335

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase II Study of MEDI4736 for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers (Lung-Map Sub-Study)

This phase II trial studies how well durvalumab works in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a "non-match" sub-study that includes all screened patients not eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as durvalumab, may be able to shrink tumors. Durvalumab may be effective in treating patients with squamous cell lung cancer.

NCT02766335 Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7
MeSH: Carcinoma Lung Neoplasms
HPO: Carcinoma Neoplasm of the lung

3 Interventions

Name: Docetaxel

Description: Given IV

Type: Drug

Arm II (docetaxel - closed to accrual 4/2015)

Name: Durvalumab

Description: Given IV

Type: Biological

Arm I (MEDI4736 - closed to accrual 12/2015) Arm III (MEDI4736 retreatment)

Name: Laboratory Biomarker Analysis

Description: Correlative studies

Type: Other

Arm I (MEDI4736 - closed to accrual 12/2015) Arm II (docetaxel - closed to accrual 4/2015) Arm III (MEDI4736 retreatment)


Primary Outcomes

Description: Estimated by proportions, counting patients with unknown response status as non-responders.

Measure: Response rate (confirmed and unconfirmed, complete and partial), as defined by Response Evaluation Criteria in Solid Tumors 1.1

Time: Up to 3 years

Secondary Outcomes

Description: Estimated using the method of Kaplan-Meier. Ninety-five percent confidence intervals for the medians will be estimated using the Brookmeyer-Crowley method. In addition, survival percentages at 6 and 12 months will also be assessed.

Measure: Investigator-assessed progression-free survival all patients and the subset of PD-L1 positive patients, as defined by Response Evaluation Criteria in Solid Tumors criteria

Time: Up to 3 years

Description: Estimated using the method of Kaplan-Meier. Ninety-five percent confidence intervals for the medians will be estimated using the Brookmeyer-Crowley method. In addition, survival percentages at 6 and 12 months will also be assessed.

Measure: Investigator-assessed progression-free survival assessed using a modified response criteria adapted for immunotherapy

Time: From date of sub-study registration to date of first documentation of immune related response criteria-progression assessed by local review or symptomatic deterioration (as defined above), or death due to any cause, assessed up to 3 years

Description: Estimated using the method of Kaplan-Meier. Ninety-five percent confidence intervals for the medians will be estimated using the Brookmeyer-Crowley method. In addition, survival percentages at 6 and 12 months will also be assessed.

Measure: Overall survival

Time: Up to 3 years

Description: The frequency and severity of toxicities will be evaluated.

Measure: Toxicity frequencies, monitored using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Time: Up to 3 years

Other Outcomes

Description: Will be monitored by the percentage of screened patients that register to a therapeutic sub-study.

Measure: Screen success rate

Time: Up to 3 years

Description: Will be monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to. (Design #1)

Measure: Treatment arm randomization acceptance rate

Time: Up to 3 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 S1400A

Inclusion Criteria: - Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) - Patients must have been assigned to S1400A - Patients must not have any prior exposure to immunotherapy such as, but not limited to anti-programmed death 1 (PD-1) or anti-PD-L1 antibodies; prior exposure to the following is allowed: anti-cytotoxic T lymphocyte antigen 4 (CTLA-4) antibodies, live attenuated vaccines, anti-EGFR agents and sargramostim (GM-GSF) - Patients must not have received nitrosoureas or mitomycin-C within 42 days prior to sub-study registration - Patients must not have any active or prior documented autoimmune or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegener syndrome; Hashimoto syndrome) within 3 years prior to sub-study registration; patients with vitiligo, alopecia, Grave's disease, or psoriasis requiring systemic treatment within the past 3 years are not eligible - Patients must not have any history of primary immunodeficiency - Patients must not have received any immunosuppressive medication within 28 days prior to sub-study registration and must not be planning to receive any such agents while on protocol treatment; however, intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent are allowed - Patients must not have any prior grade >= 3 immune-related adverse event (irAE) or any unresolved irAE > grade 1 - Patients must not have any history of organ transplant that requires use of immunosuppressives - Patients must not have any known allergy or reaction to any component of the MEDI4736 formulation - Patients must not have a known history of tuberculosis - Patients must not have received a live attenuated vaccination within 28 days prior to sub-study registration - Patients must not have known human immunodeficiency virus (HIV), hepatitis B or C positivity - Patients must also be offered participation in banking for future use of specimens - STEP 2 TO MEDI4736 RE-TREATMENT REGISTRATION: - Patient must have progressed following 12 months of treatment with MEDI4736; patients who discontinue MEDI4736 prior to the completion of 12 months (for any reason) are not eligible; patients who have already completed two 12-month periods of treatment are not eligible - Patients may have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to re-treatment registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to re-treatment registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to RE-TREATMENT registration - Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to RE-TREATMENT registration; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment and prior to RE-TREATMENT registration, AND patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to RE-TREATMENT registration - Patients must not have received any treatment after discontinuing MEDI4736 with the following exceptions; localized palliative radiation therapy is allowed for symptom management, provided and treatment is completed >= 14 days prior to RE-TREATMENT registration; local treatment for brain metastases is allowed - Patients must not have received any immunosuppressive medication within 28 days prior to RE-TREATMENT registration and must not be planning to receive any such agents while on protocol treatment; however, intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent are allowed - Patients must not have any prior grade >= 3 immune-related adverse event (irAE) or any unresolved irAE > grade 1 (MEDI4736 RE-TREATMENT) - Patients must not have received a live attenuated vaccination within 28 days prior to RE-TREATMENT registration - Patients must not have known HIV, hepatitis B or hepatitis C positivity - Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable - Absolute neutrophil count (ANC) >= 1,500/mcl obtained within 28 days prior to RE-TREATMENT registration - Platelet count >= 100,000 mcl obtained within 28 days prior to RE-TREATMENT registration - Hemoglobin >= 9 g/dL obtained within 28 days prior to RE-TREATMENT registration - Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to RE-TREATMENT registration; for patients with liver metastases, bilirubin must be =< 5 x IULN - Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to RE-TREATMENT registration (if both ALT and AST are done, both must be =< 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN) - Patients must have a serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula - Patients must have Zubrod performance status of 0-1 documented within 28 days prior to RE-TREATMENT registration - Prestudy history and physical exam must be obtained within 28 days prior to RE-TREATMENT registration - Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator) - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Inclusion Criteria: - Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) - Patients must have been assigned to S1400A - Patients must not have any prior exposure to immunotherapy such as, but not limited to anti-programmed death 1 (PD-1) or anti-PD-L1 antibodies; prior exposure to the following is allowed: anti-cytotoxic T lymphocyte antigen 4 (CTLA-4) antibodies, live attenuated vaccines, anti-EGFR agents and sargramostim (GM-GSF) - Patients must not have received nitrosoureas or mitomycin-C within 42 days prior to sub-study registration - Patients must not have any active or prior documented autoimmune or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegener syndrome; Hashimoto syndrome) within 3 years prior to sub-study registration; patients with vitiligo, alopecia, Grave's disease, or psoriasis requiring systemic treatment within the past 3 years are not eligible - Patients must not have any history of primary immunodeficiency - Patients must not have received any immunosuppressive medication within 28 days prior to sub-study registration and must not be planning to receive any such agents while on protocol treatment; however, intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent are allowed - Patients must not have any prior grade >= 3 immune-related adverse event (irAE) or any unresolved irAE > grade 1 - Patients must not have any history of organ transplant that requires use of immunosuppressives - Patients must not have any known allergy or reaction to any component of the MEDI4736 formulation - Patients must not have a known history of tuberculosis - Patients must not have received a live attenuated vaccination within 28 days prior to sub-study registration - Patients must not have known human immunodeficiency virus (HIV), hepatitis B or C positivity - Patients must also be offered participation in banking for future use of specimens - STEP 2 TO MEDI4736 RE-TREATMENT REGISTRATION: - Patient must have progressed following 12 months of treatment with MEDI4736; patients who discontinue MEDI4736 prior to the completion of 12 months (for any reason) are not eligible; patients who have already completed two 12-month periods of treatment are not eligible - Patients may have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to re-treatment registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to re-treatment registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to RE-TREATMENT registration - Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to RE-TREATMENT registration; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment and prior to RE-TREATMENT registration, AND patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to RE-TREATMENT registration - Patients must not have received any treatment after discontinuing MEDI4736 with the following exceptions; localized palliative radiation therapy is allowed for symptom management, provided and treatment is completed >= 14 days prior to RE-TREATMENT registration; local treatment for brain metastases is allowed - Patients must not have received any immunosuppressive medication within 28 days prior to RE-TREATMENT registration and must not be planning to receive any such agents while on protocol treatment; however, intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent are allowed - Patients must not have any prior grade >= 3 immune-related adverse event (irAE) or any unresolved irAE > grade 1 (MEDI4736 RE-TREATMENT) - Patients must not have received a live attenuated vaccination within 28 days prior to RE-TREATMENT registration - Patients must not have known HIV, hepatitis B or hepatitis C positivity - Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable - Absolute neutrophil count (ANC) >= 1,500/mcl obtained within 28 days prior to RE-TREATMENT registration - Platelet count >= 100,000 mcl obtained within 28 days prior to RE-TREATMENT registration - Hemoglobin >= 9 g/dL obtained within 28 days prior to RE-TREATMENT registration - Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to RE-TREATMENT registration; for patients with liver metastases, bilirubin must be =< 5 x IULN - Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to RE-TREATMENT registration (if both ALT and AST are done, both must be =< 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN) - Patients must have a serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula - Patients must have Zubrod performance status of 0-1 documented within 28 days prior to RE-TREATMENT registration - Prestudy history and physical exam must be obtained within 28 days prior to RE-TREATMENT registration - Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator) - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7 Carcinoma Lung Neoplasms CO-PRIMARY OBJECTIVES: I. To assess the response rate (confirmed and unconfirmed, complete and partial) among patients treated with durvalumab (MEDI4736). --- S1400A ---

Inclusion Criteria: - Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) - Patients must have been assigned to S1400A - Patients must not have any prior exposure to immunotherapy such as, but not limited to anti-programmed death 1 (PD-1) or anti-PD-L1 antibodies; prior exposure to the following is allowed: anti-cytotoxic T lymphocyte antigen 4 (CTLA-4) antibodies, live attenuated vaccines, anti-EGFR agents and sargramostim (GM-GSF) - Patients must not have received nitrosoureas or mitomycin-C within 42 days prior to sub-study registration - Patients must not have any active or prior documented autoimmune or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegener syndrome; Hashimoto syndrome) within 3 years prior to sub-study registration; patients with vitiligo, alopecia, Grave's disease, or psoriasis requiring systemic treatment within the past 3 years are not eligible - Patients must not have any history of primary immunodeficiency - Patients must not have received any immunosuppressive medication within 28 days prior to sub-study registration and must not be planning to receive any such agents while on protocol treatment; however, intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent are allowed - Patients must not have any prior grade >= 3 immune-related adverse event (irAE) or any unresolved irAE > grade 1 - Patients must not have any history of organ transplant that requires use of immunosuppressives - Patients must not have any known allergy or reaction to any component of the MEDI4736 formulation - Patients must not have a known history of tuberculosis - Patients must not have received a live attenuated vaccination within 28 days prior to sub-study registration - Patients must not have known human immunodeficiency virus (HIV), hepatitis B or C positivity - Patients must also be offered participation in banking for future use of specimens - STEP 2 TO MEDI4736 RE-TREATMENT REGISTRATION: - Patient must have progressed following 12 months of treatment with MEDI4736; patients who discontinue MEDI4736 prior to the completion of 12 months (for any reason) are not eligible; patients who have already completed two 12-month periods of treatment are not eligible - Patients may have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to re-treatment registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to re-treatment registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to RE-TREATMENT registration - Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to RE-TREATMENT registration; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment and prior to RE-TREATMENT registration, AND patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to RE-TREATMENT registration - Patients must not have received any treatment after discontinuing MEDI4736 with the following exceptions; localized palliative radiation therapy is allowed for symptom management, provided and treatment is completed >= 14 days prior to RE-TREATMENT registration; local treatment for brain metastases is allowed - Patients must not have received any immunosuppressive medication within 28 days prior to RE-TREATMENT registration and must not be planning to receive any such agents while on protocol treatment; however, intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent are allowed - Patients must not have any prior grade >= 3 immune-related adverse event (irAE) or any unresolved irAE > grade 1 (MEDI4736 RE-TREATMENT) - Patients must not have received a live attenuated vaccination within 28 days prior to RE-TREATMENT registration - Patients must not have known HIV, hepatitis B or hepatitis C positivity - Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable - Absolute neutrophil count (ANC) >= 1,500/mcl obtained within 28 days prior to RE-TREATMENT registration - Platelet count >= 100,000 mcl obtained within 28 days prior to RE-TREATMENT registration - Hemoglobin >= 9 g/dL obtained within 28 days prior to RE-TREATMENT registration - Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to RE-TREATMENT registration; for patients with liver metastases, bilirubin must be =< 5 x IULN - Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to RE-TREATMENT registration (if both ALT and AST are done, both must be =< 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN) - Patients must have a serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula - Patients must have Zubrod performance status of 0-1 documented within 28 days prior to RE-TREATMENT registration - Prestudy history and physical exam must be obtained within 28 days prior to RE-TREATMENT registration - Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator) - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Inclusion Criteria: - Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) - Patients must have been assigned to S1400A - Patients must not have any prior exposure to immunotherapy such as, but not limited to anti-programmed death 1 (PD-1) or anti-PD-L1 antibodies; prior exposure to the following is allowed: anti-cytotoxic T lymphocyte antigen 4 (CTLA-4) antibodies, live attenuated vaccines, anti-EGFR agents and sargramostim (GM-GSF) - Patients must not have received nitrosoureas or mitomycin-C within 42 days prior to sub-study registration - Patients must not have any active or prior documented autoimmune or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegener syndrome; Hashimoto syndrome) within 3 years prior to sub-study registration; patients with vitiligo, alopecia, Grave's disease, or psoriasis requiring systemic treatment within the past 3 years are not eligible - Patients must not have any history of primary immunodeficiency - Patients must not have received any immunosuppressive medication within 28 days prior to sub-study registration and must not be planning to receive any such agents while on protocol treatment; however, intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent are allowed - Patients must not have any prior grade >= 3 immune-related adverse event (irAE) or any unresolved irAE > grade 1 - Patients must not have any history of organ transplant that requires use of immunosuppressives - Patients must not have any known allergy or reaction to any component of the MEDI4736 formulation - Patients must not have a known history of tuberculosis - Patients must not have received a live attenuated vaccination within 28 days prior to sub-study registration - Patients must not have known human immunodeficiency virus (HIV), hepatitis B or C positivity - Patients must also be offered participation in banking for future use of specimens - STEP 2 TO MEDI4736 RE-TREATMENT REGISTRATION: - Patient must have progressed following 12 months of treatment with MEDI4736; patients who discontinue MEDI4736 prior to the completion of 12 months (for any reason) are not eligible; patients who have already completed two 12-month periods of treatment are not eligible - Patients may have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to re-treatment registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to re-treatment registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to RE-TREATMENT registration - Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to RE-TREATMENT registration; patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment and prior to RE-TREATMENT registration, AND patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to RE-TREATMENT registration - Patients must not have received any treatment after discontinuing MEDI4736 with the following exceptions; localized palliative radiation therapy is allowed for symptom management, provided and treatment is completed >= 14 days prior to RE-TREATMENT registration; local treatment for brain metastases is allowed - Patients must not have received any immunosuppressive medication within 28 days prior to RE-TREATMENT registration and must not be planning to receive any such agents while on protocol treatment; however, intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent are allowed - Patients must not have any prior grade >= 3 immune-related adverse event (irAE) or any unresolved irAE > grade 1 (MEDI4736 RE-TREATMENT) - Patients must not have received a live attenuated vaccination within 28 days prior to RE-TREATMENT registration - Patients must not have known HIV, hepatitis B or hepatitis C positivity - Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable - Absolute neutrophil count (ANC) >= 1,500/mcl obtained within 28 days prior to RE-TREATMENT registration - Platelet count >= 100,000 mcl obtained within 28 days prior to RE-TREATMENT registration - Hemoglobin >= 9 g/dL obtained within 28 days prior to RE-TREATMENT registration - Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to RE-TREATMENT registration; for patients with liver metastases, bilirubin must be =< 5 x IULN - Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to RE-TREATMENT registration (if both ALT and AST are done, both must be =< 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN) - Patients must have a serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula - Patients must have Zubrod performance status of 0-1 documented within 28 days prior to RE-TREATMENT registration - Prestudy history and physical exam must be obtained within 28 days prior to RE-TREATMENT registration - Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator) - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7 Carcinoma Lung Neoplasms CO-PRIMARY OBJECTIVES: I. To assess the response rate (confirmed and unconfirmed, complete and partial) among patients treated with durvalumab (MEDI4736). --- S1400A --- --- S1400A ---



HPO Nodes


HPO:
Carcinoma
Genes 11
PTEN CDKN1B APC MLH1 MSH2 FGFR3 KIT DKC1 RSPO1 STK11 NLRP1
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN