Clinical Trials /

Lung-MAP S1400K: c-MET Positive

NCT03574753

Description:

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.

Related Conditions:
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Lung-MAP S1400K: c-MET Positive
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: S1400K
  • NCT ID: NCT03574753

Conditions

  • Recurrent Squamous Cell Lung Carcinoma
  • Stage IV Squamous Cell Lung Carcinoma AJCC V7

Interventions

DrugSynonymsArms
ABBV-399ABBV-399

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
ABBV-399ExperimentalC-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.
  • ABBV-399

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response Rate
Time Frame:11 months
Safety Issue:
Description: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

Measure:Investigator-assessed progression-free survival (IA-PFS)
Time Frame:Up to 3 years
Safety Issue:
Description:Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.
Measure:Overall survival (OS)
Time Frame:Up to 3 years
Safety Issue:
Description:Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.
Measure:Overall response rate (ORR)
Time Frame:Up to 3 years
Safety Issue:
Description: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.
Measure:Duration of response (DoR)
Time Frame:Up to 3 years
Safety Issue:
Description:Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median times.
Measure: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
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Southwest Oncology Group

Last Updated