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
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)|
|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|
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.
ABBV-399 (Process II), 2.7 mg/kg IV over 30 ± 10 minutes, Day 1, Every 21 days
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Vassiliki A. Papadimitrakopoulou 713-792-3245 firstname.lastname@example.org|
|Principal Investigator: Vassiliki A. Papadimitrakopoulou|