S1400 Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer

S
Shadia Jalal, MD

Primary Investigator

Overview

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study "Master Protocol". The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Description

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study "Master Protocol". The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Lung Cancer
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria
Patients must have pathologically proven squamous cell non-small cell lung cancer (NSCLC) confirmed by tumor biopsy and/or fine-needle aspiration
Disease must be either advanced, incurable stage IIIB or stage IV NSCLC
Patients must have progressed after receiving exactly one front-line platinum containing metastatic chemotherapy regimen
Patients must have adequate tumor tissue available
Exclusion Criteria
Patients have a known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion
Patients whose biomarker profiling results indicate the presence of an EGFR mutation or ALK fusion
Patients have documented evidence of acute hepatitis or have an active or uncontrolled infection
Patients have a known history of human immunodeficiency virus (HIV) seropositivity
Pregnant or nursing
Patients have a history of organ transplant that requires use of immunosuppressives
Patients have a known history of tuberculosis
Patients have known HIV, hepatitis B or C positivity
Patients have Type 1 or 2 diabetes which requires insulin
Patients have active or a history of small or large intestine inflammation such as Crohn's disease or ulcerative colitis
Patients require daily supplemental oxygen


Additional Information:

Updated on 20 Nov 2022. Study ID: 1407538042

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