Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
- Conditions
- Non-small Cell Lung Cancer Stage IINon-small Cell Lung CancerNon-small Cell Lung Cancer Stage INon-small Cell Lung Cancer Stage III
- Interventions
- Device: AVENIO ctDNA Surveillance KitDrug: Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapy
- Registration Number
- NCT04585477
- Lead Sponsor
- Stanford University
- Brief Summary
In this study circulating tumor DNA (ctDNA) blood testing is used to detect the residual blood cancer. If residual cancer using this blood test is detected there may be at higher risk of having the cancer return. The study is going to test whether or not the number of circulating cancer cells detected in the blood can be reduced by administration durvalumab after the standard treatment if you are tested positive for the residual cancer.
- Detailed Description
Primary Objective:
The primary objective of this study is to measure the change in ctDNA from trial enrollment to after 2 cycles of adjuvant durvalumab in subjects with stage I to III NSCLC who had positive ctDNA following definitive treatment with surgery or radiation and completion of adjuvant standard of care chemotherapy. Secondary Objectives
1. To compare disease free survival (DFS)
2. To compare overall survival (OS)
3. To evaluate the frequency and severity of toxicity
4. To evaluate the severity of toxicity
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 minimal residue disease positive(MRD+) AVENIO ctDNA Surveillance Kit Subjects with detectable ctDNA (MRD+) will receive up to 12 cycles of durvalumab (1500mg dose by intravenous (by vein) injection every 28 days). ctDNA will be re checked following 2 cycles (8 weeks) of durvalumab and compared to baseline levels. In the absence of progression or toxicity after 2 cycles, subject will continue with durvalumab to complete 1 year of treatment about 10 additional cycles). Subjects will be monitored for secondary endpoints of progression free survival (PFS) and overall survival (OS). Cohort 1 minimal residue disease positive(MRD+) Durvalumab Subjects with detectable ctDNA (MRD+) will receive up to 12 cycles of durvalumab (1500mg dose by intravenous (by vein) injection every 28 days). ctDNA will be re checked following 2 cycles (8 weeks) of durvalumab and compared to baseline levels. In the absence of progression or toxicity after 2 cycles, subject will continue with durvalumab to complete 1 year of treatment about 10 additional cycles). Subjects will be monitored for secondary endpoints of progression free survival (PFS) and overall survival (OS). Cohort 1 minimal residue disease positive(MRD+) Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapy Subjects with detectable ctDNA (MRD+) will receive up to 12 cycles of durvalumab (1500mg dose by intravenous (by vein) injection every 28 days). ctDNA will be re checked following 2 cycles (8 weeks) of durvalumab and compared to baseline levels. In the absence of progression or toxicity after 2 cycles, subject will continue with durvalumab to complete 1 year of treatment about 10 additional cycles). Subjects will be monitored for secondary endpoints of progression free survival (PFS) and overall survival (OS). Cohort 2 minimal residue disease negative (MRD-) AVENIO ctDNA Surveillance Kit Subjects with undetectable ctDNA (MRD) will receive Standard of care and no treatment Cohort 2 minimal residue disease negative (MRD-) Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapy Subjects with undetectable ctDNA (MRD) will receive Standard of care and no treatment
- Primary Outcome Measures
Name Time Method Decrease in ctDNA Level 8 weeks Change in minimal residual disease (MRD) will be assessed on the basis of reduction of circulating tumor DNA (ctDNA) in the blood of participants in Cohort 1 MRD+ only. ctDNA is an indicator of MRD. The outcome will be reported as the number of participants who have a ≥ 3-fold drop in ctDNA levels after 2 cycles of durvalumab treatment, a number without dispersion.
- Secondary Outcome Measures
Name Time Method Related Adverse Events 12 months Related adverse events (AEs) are deleterious events determined to be possibly, probably, or definitely-related to durvalumab treatment. The outcome will be reported as the number of related AEs experienced by the participants in Cohort 1 MRD+ only (ie, durvalumab treatment cohort), a number without dispersion.
Presence or absence of detectable ctDNA 8 weeks Circulating tumor DNA (ctDNA) in the blood is an indicator of minimal residual disease (MRD), a risk factor for future relapse or progression. The outcome will be reported as the number of Cohort 1 MRD+ participants for whom, following 2 cycles of durvalumab, ctDNA was detected, not detected, or unable to be determined, each a number without dispersion. Available data for Cohort 2 MRD- participants will also be reported for the 8-week timepoint.
Disease-free survival (DFS) 8 weeks Disease-free survival (DFS) is defined as the number of participants remaining alive without disease progression (DP), symptomatic deterioration, or death due to any cause. DP is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as follows.
* Complete Response (CR) = Disappearance of all target lesions
* Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions
* Progressive disease (PD) = 20% increase in the sum of the diameters of target lesions (must be \> 5 mm), unequivocal progression of non-target lesions, and/or the appearance of one or more new lesion(s)
* Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome will be reported as the number of participants who meet the criteria for DFS, a number without dispersion.Overall survival (OS) 12 months Overall survival (OS) defined as the duration from study registration until death due to any cause. The outcome will be reported as the number of participants in each cohort known to be alive at 12 months after study registration, a number without dispersion.
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States