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Lung-MAP S1400K: c-MET Positive

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ClinicalTrials.gov Identifier: NCT03574753
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

S1400K of Lung-MAP seeks to evaluate the overall response rate with ABBV-399 (Process II) in patients with c-MET positive SCCA.

S1400K is a biomarker-driven study for patients with Stage IV or recurrent squamous cell lung cancer, who have c-MET positive squamous cell tumors.


Condition or disease Intervention/treatment Phase
Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC V7 Drug: ABBV-399 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of ABBV-399 in Patients With C-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP SUB-STUDY)
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : January 5, 2019
Estimated Study Completion Date : January 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: ABBV-399

C-MET overexpression is seen in 30% of patients with lung squamous cell carcinoma (SCCA). ABBV-399 (Process II) is a first-in-class antibody-drug conjugate (ADC) comprised of ABT-700, an anti-c-Met monoclonal antibody linked to monomethyl auristatin E (MMAE), which is a potent microtubule inhibitor. This delivers a direct anti-mitotic effect without relying on MET pathway inhibition.

ABBV-399 will be administered intravenously on day 1 of each 21-day cycle. Treatment will continue in consenting patients until disease progression or intolerable toxicity.

Drug: ABBV-399
ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days




Primary Outcome Measures :
  1. Response Rate [ Time Frame: 11 months ]

    Primary analyses will be performed using a more restricted definition of c-Met -positivity criteria.

    The observation of at least 10 responses will be considered evidence to rule out the null hypothesis of a 15% response rate.



Secondary Outcome Measures :
  1. Investigator-assessed progression-free survival (IA-PFS) [ Time Frame: Up to 3 years ]
    Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.

  2. Overall survival (OS) [ Time Frame: Up to 3 years ]
    Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.

  3. Overall response rate (ORR) [ Time Frame: Up to 3 years ]
    A design with 91% power and 1-sided 0.05 level type I error would require 40 eligible patients to rule out an objective response rate (ORR) of 15% or less if the true ORR is 35% or greater.

  4. Duration of response (DoR) [ Time Frame: Up to 3 years ]
    Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.

  5. Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: up to 3 years ]
    With 40 patients, toxicity rates can be estimated within 16% with 95% confidence. Any toxicity with at least 5% prevalence has at least an 87% chance of being observed.



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

•Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER 5.1 Sub-Study Specific Disease Related Criteria

  1. Patients must have been assigned to S1400I.
  2. Patients must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
  3. Patients must not have an active, known, or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.

5.2 Sub-Study Specific Clinical/Laboratory Criteria

  1. Patients must not have any known allergy or reaction to any component of the nivolumab and ipilimumab formulations.
  2. Patients must not have received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to sub-study registration. Inhaled or topical steroids, and adrenal replacement doses <= 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
  3. Patients must not have a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. Patients with a positive hepatitis C antibody with a negative viral load are allowed. [This criterion replaces common eligibility criteria in Section 5.3m.]
  4. Patients must not have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). [This criterion replaces common eligibility criteria in Section 5.3n.]
  5. Patients must not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity.
  6. Patients must also be offered participation in banking for future use of specimens as described in Section 15.0.
  7. Patients must have a Lipase, Amylase, TSH with reflex Free T3/T4 performed within 7 days prior to sub-study registration. Additional timepoints are noted in Section 9.0, Study Calendar. [Note: For the Canadian sites, testing for lipase only is acceptable.]
  8. Patients must not have any Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia (see Section 18.1b).

    1. Patients with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drug should have an EKG and echocardiogram performed to evaluate cardiac function as clinically indicated.
    2. Patients with evidence of congestive heart failure (CHF), myocardial infarction (MI), cardiomyopathy, or myositis should have a cardiac evaluation including lab tests and cardiology consultations as clinically indicated including EKG, CPK, troponin, and echocardiogram.
  9. Patients who can complete PRO forms in English are required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I EQ-5D Questionnaire within 14 days prior to registration (see Section 18.2 of S1400I). NOTE: Patients enrolled to S1400I prior to 9/1/2016 are not eligible for the PRO study.

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): NCT03574753


Locations
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Vassiliki A. Papadimitrakopoulou    713-792-3245    vpapadim@mdanderson.org   
Principal Investigator: Vassiliki A. Papadimitrakopoulou         
Sponsors and Collaborators
Southwest Oncology Group

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT03574753     History of Changes
Other Study ID Numbers: S1400K
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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