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Report for Clinical Trial NCT03373760

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients With Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-Map Non-Match Sub-Study)

This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.

NCT03373760 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: Durvalumab

Description: Given IV
Type: Biological
Group Labels: 1

Treatment (tremelimumab, durvalumab)

Name: Laboratory Biomarker Analysis

Description: Correlative studies
Type: Other
Group Labels: 1

Treatment (tremelimumab, durvalumab)

Name: Tremelimumab

Description: Given IV
Type: Biological
Group Labels: 1

Treatment (tremelimumab, durvalumab)


Primary Outcomes

Description: Estimated within 13% with 95% confidence.

Measure: Objective response rate assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Time: Up to 3 years

Secondary Outcomes

Description: Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median DOR.

Measure: Duration of response (DOR)

Time: Up to 3 years

Description: Will be estimated using the method of Kaplan-Meier.

Measure: Immune-Related Response Criteria investigator-assessed progression-free survival (irRC-IA-PFS) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Time: From date of registration to date of first documentation of irRC progression or death due to any cause, assessed up to 3 years

Description: Toxicity rates can be estimated within 13% with 95% confidence. Any toxicity with at least 5% prevalence has at least a 95% chance of being observed.

Measure: Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Time: Up to 3 years

Description: Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median IA-PFS.

Measure: Investigator-assessed progression-free survival (IA-PFS)

Time: 6 months after completion of accrual

Description: Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median OS.

Measure: Overall survival (OS)

Time: 6 months after completion of accrual

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 S1400A

TERTIARY OBJECTIVES: I. To explore the association of potential predictive markers identified in S1400A, with response and progression-free survival (PFS). --- S1400A ---


2 S1400F

The Brookmeyer-Crowley method will be used to calculate confidence intervals for median OS.. Inclusion Criteria: - Patients must have been assigned to S1400F - Patients must have progressed during or after prior platinum-based chemotherapy; patients whose only prior platinum-based chemotherapy regimen was for stage I-III disease (i.e. --- S1400F ---

post Hashimoto syndrome) who are stable on hormone replacement therapy are 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 these medications while on protocol therapy; systemic corticosteroids must be stopped at least 24 hours prior to sub-study registration; however, intranasal and inhaled corticosteroids are allowed at any time before and during protocol therapy - Patients must not have experienced a grade 3 or worse immune-related adverse event (irAE) (except asymptomatic nonbullous/nonexfoliative rash) or any unresolved irAE grade 2, nor have experienced a toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy - 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 durvalumab (MEDI4736) and/or tremelimumab formulation - Patients must not have clinical signs or symptoms of active tuberculosis infection - 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), or a known positive test for hepatitis B virus surface antigen (HBV sAg), or hepatitis C virus ribonucleic acid (HCV antibody) indicating current acute or chronic infection; patients with a positive hepatitis C antibody with a negative viral load are allowed - Patients must have a thyroid-stimulating hormone (TSH) with reflex free T3/free T4 (if TSH is out of normal range) and electrocardiogram (EKG) obtained within 7 days prior to sub-study registration - Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens Inclusion Criteria: - Patients must have been assigned to S1400F - Patients must have progressed during or after prior platinum-based chemotherapy; patients whose only prior platinum-based chemotherapy regimen was for stage I-III disease (i.e. --- S1400F ---



HPO Nodes


HPO: