Vorolanib + Atezolizumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04373369|
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Extensive-stage Small Cell Lung Cancer||Drug: Vorolanib Drug: Atezolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Maintenance Vorolanib and Atezolizumab in Patients With Extensive-stage SCLC|
|Actual Study Start Date :||October 7, 2020|
|Estimated Primary Completion Date :||October 31, 2023|
|Estimated Study Completion Date :||October 31, 2025|
Experimental: Vorolanib + Atezolizumab
Consenting and eligible participants who have no evidence of tumor progression after 3 to 4 cycles of standard-of-care induction therapy will receive atezolizumab intravenously (IV) every 3 weeks and vorolanib by mouth daily. Participants can continue to receive treatment up to two years.
Vorolanib is administered orally at a dose of 200 mg on Days 1 through 21 of each 21-day cycle.
Other Name: X-82
Atezolizumab is administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle.
Other Name: Tecentriq
- Progression-free survival at 6 months [ Time Frame: 6 months ]
Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study.) In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Kaplan-Meier product limit estimator will be used to estimate progression-free survival (PFS) at 6 months, with the inclusion of 90% confidence interval.
- Progression-free survival [ Time Frame: Up to 3 years post start of treatment (up to 5 years) ]
Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Subjects lost to follow-up will be excluded from the analysis.
Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study.) In addition to he relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
- Overall survival [ Time Frame: Up to 3 years post start of treatment (up to 5 years) ]Overall survival is defined as the length of time from the start of study treatment that patients diagnosed with the disease are still alive. Kaplan-Meier product limit estimator will be used to estimate the overall survival rate.
- Safety and tolerability of treatment regimen as measured by the frequency of adverse events [ Time Frame: From the start of treatment until 30 days after completion of treatment (up to 25 months). ]The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
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): NCT04373369
|Contact: Daniel Morgensztern, MDfirstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Daniel Morgensztern, MD 314-362-5817 email@example.com|
|Sub-Investigator: Maria Baggstrom, MD|
|Sub-Investigator: Siddhartha Devarakonda, MD|
|Sub-Investigator: Ramaswamy Govindan, MD|
|Sub-Investigator: Peter Oppelt, MD|
|Sub-Investigator: Kevin Palka, MD|
|Sub-Investigator: Timothy Rearden, MD|
|Sub-Investigator: Caron Ridgden, MD|
|Sub-Investigator: Anna Roshal, MD|
|Sub-Investigator: Saiama Waqar, MD|
|Sub-Investigator: Jeff Ward, MD|
|Sub-Investigator: Brett Herzog, MD|
|Principal Investigator: Daniel Morgensztern, MD|
|Principal Investigator:||Daniel Morgensztern, MD||Washington University School of Medicine|