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Trial record 1 of 7 for:    S1400
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S1400A Lung-Map: MEDI4736 as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02766335
First Posted: May 9, 2016
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
  Purpose
This phase II trial studies how well anti-B7H1 monoclonal antibody MEDI4736 (MEDI4736) 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 MEDI4736, may be able to shrink tumors. MEDI4736 may be effective in treating patients with squamous cell lung cancer.

Condition Intervention Phase
Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma Drug: Docetaxel Biological: Durvalumab Other: Laboratory Biomarker Analysis Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Response rate (confirmed and unconfirmed, complete and partial), as defined by RECIST 1.1 [ Time Frame: Up to 3 years ]
    Estimated by proportions, counting patients with unknown response status as non-responders.


Secondary Outcome Measures:
  • IA-PFS all patients and the subset of PD-L1 positive patients, as defined by RECIST criteria [ Time Frame: Up to 3 years ]
    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.

  • IA-PFS assessed using a modified response criteria adapted for immunotherapy (irRC-IA-PFS) [ Time Frame: From date of sub-study registration to date of first documentation of irRC-progression assessed by local review or symptomatic deterioration (as defined above), or death due to any cause, assessed up to 3 years ]
    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.

  • OS [ Time Frame: Up to 3 years ]
    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.

  • Toxicity frequencies, monitored using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 3 years ]
    The frequency and severity of toxicities will be evaluated.


Other Outcome Measures:
  • Screen success rate, monitored by the percentage of screened patients that register to a therapeutic sub-study [ Time Frame: Up to 3 years ]
  • Treatment arm randomization acceptance rate, monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to (Design #1) [ Time Frame: Up to 3 years ]

Estimated Enrollment: 100
Study Start Date: June 2014
Estimated Study Completion Date: April 2027
Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (MEDI4736 - closed to accrual 12/2015)
Patients receive anti-B7H1 monoclonal antibody MEDI4736 IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.
Biological: Durvalumab
Given IV
Other Names:
  • Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer
  • MEDI-4736
  • MEDI4736
Other: Laboratory Biomarker Analysis
Correlative studies
Active Comparator: Arm II (docetaxel - closed to accrual 4/2015)
Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15)
Drug: Docetaxel
Given IV
Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: Arm III (MEDI4736 retreatment)
For patients assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, patients may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Patients will only be able to restart treatment once; thus a maximum of two 12-month periods will be allowed. Patients receive anti-B7H1 monoclonal antibody MEDI4736 IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.
Biological: Durvalumab
Given IV
Other Names:
  • Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer
  • MEDI-4736
  • MEDI4736
Other: Laboratory Biomarker Analysis
Correlative studies

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 other 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-Epidermal Growth Factor Receptor (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; Wegner 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 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 patient has no residual neurological dysfunction and has been off corticosteroids for at least 1 day 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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766335


  Show 993 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Vassiliki Papadimitrakopoulou Southwest Oncology Group
  More Information

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT02766335     History of Changes
Other Study ID Numbers: S1400A
NCI-2014-01378 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1400A ( Other Identifier: SWOG )
S1400A ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
First Submitted: May 6, 2016
First Posted: May 9, 2016
Last Update Posted: July 13, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Immunoglobulins
Antibodies, Monoclonal
Immunoglobulin G
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs