Conditions: Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 116
Healthy volunteers: no

Brief summary:
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.

Detailed description:
CO-PRIMARY OBJECTIVES:

I. To assess the response rate (confirmed and unconfirmed, complete and partial) among patients treated with durvalumab (MEDI4736).

II. To assess the response rate (confirmed and unconfirmed, complete and partial) among programmed death ligand 1 (PD-L1) positive patients treated with MEDI4736.

SECONDARY AND EXPLORATORY OBJECTIVES:

I. To assess investigator-assessed progression-free survival (IA-PFS) among patients treated with MEDI4736.

II. To assess IA-PFS among PD-L1 positive patients treated with MEDI4736. III. To assess overall survival (OS) in patients treated with MEDI4736. IV. To assess overall survival (OS) in PD-L1 positive patients treated with MEDI4736.

V. To evaluate the frequency and severity of toxicities associated with MEDI4736.

VI. To assess immune-related IA-PFS using a modified response criteria adapted for immunotherapy (immune-related response criteria \[irRC\]-IA-PFS) in all patients and in the subset of patients determined to be PD-L1 positive treated with MEDI4736.

VII. To compare IA-PFS, irRC-IA-PFS, OS, toxicity and response rates between patients randomized to MEDI4736 versus docetaxel.

TRANSLATIONAL MEDICINE OBJECTIVES:

I. To identify additional predictive or prognostic tumor/blood biomarkers beyond the chosen biomarker.

II. To identify potential resistance biomarkers at disease progression. III. To establish a tissue/blood repository from patients with refractory squamous cell cancer.

MEDI4736 RE-TREATMENT OBJECTIVES:

I. To evaluate response rates (confirmed and unconfirmed, complete and partial responses) among patients re-treated with MEDI4736.

II. To estimate median PFS from the date of re-treatment.

OUTLINE (CLOSED TO ACCRUAL 12/18/2015):

Patients with tumors that do not match one of the currently active drug-biomarker combinations receive durvalumab intravenously (IV) over 60 minutes on day 1. Courses repeat every 2 weeks for 12 months in the absence of disease progression or unacceptable toxicity. Upon evidence of progression following discontinuation of 12 months of treatment, patients may restart treatment and continue for up to 12 additional months (Arm III).

ARM I: (Closed to accrual 12/2015) Patients receive durvalumab intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.

ARM II (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)

ARM III: 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 durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, all patients are followed up every 6 months for the first 2 years and then at the end of the year 3 from date of sub-study/re-registration.

Arms:
arm 1: Patients receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. arm 2: 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) arm 3: 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 durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.

Interventions: intervention 1: Docetaxel intervention 2: Durvalumab intervention 3: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies

Protocol document:
Prot_SAP_000.pdf: 
Cover Page for Clinical Trials Document posting 
 
 
Official Title:  
S1400A, “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)” 
 
 
NCT Number: 02766335 
 
 
Version Date: 7/10/18 
 
Description: 
S1400 [NCT 02154490] is the parent study to S1400A [NCT 02766335].  
The S1400 Lung-MAP study is considered one study under one IND consisting of: 
• 
S1400 Version Control Protocol  
• 
S1400 Main Screening Protocol Component 
• 
Multiple Sub-Studies (or sub-protocols) Components  
Each component is contained in its own separate document.   
S1400A is one of these components.  Each “component” consists of the protocol 
document and its associated informed consent document(s).  Since each screening 
and sub-study component operates independently from the other components contained 
in Lung-MAP, each has its own version date and NCT number. This is due to the complexity 
of the study and how it must be entered into different computer programs.  
 


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ICF_001.pdf: 
Cover Page for Clinical Trials Document posting 
 
 
Official Title:  
S1400A, “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)” 
 
 
NCT Number: 02766335 
 
 
Version Date: 7/10/18 
 
Description: 
S1400 [NCT 02154490] is the parent study to S1400A [NCT 02766335].  
The S1400 Lung-MAP study is considered one study under one IND consisting of: 
• 
S1400 Version Control Protocol  
• 
S1400 Main Screening Protocol Component 
• 
Multiple Sub-Studies (or sub-protocols) Components  
Each component is contained in its own separate document.   
S1400A is one of these components.  Each “component” consists of the protocol 
document and its associated informed consent document(s).  Since each screening 
and sub-study component operates independently from the other components contained 
in Lung-MAP, each has its own version date and NCT number. This is due to the complexity 
of the study and how it must be entered into different computer programs.  
 


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