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Trial Summary


Protocol No.CTO-BTCRC-LUN19-396
StatusOPEN TO ACCRUAL
Principal InvestigatorHanna, Nasser
ScopeNational
PhasePhase II
Age GroupAdult
TitleA phase II study of adjuvant treatment with cisplatin-based chemotherapy plus concomitant atezolizumab in patients with stage I (tumors > 4cm), IIA, IIB, and select IIIA [T3N1-2, T4N0-2] resected non-small cell lung cancer (NSCLC) and the clearance of circulating tumor DNA (ctDNA)
DescriptionThe vast majority of patients with stage I (tumors ≥ 4cm), IIA, IIB (and select IIIA) NSCLC are managed with upfront surgery, followed by adjuvant chemotherapy. However, relapse rates remain high and are primarily due to distant, metastatic disease. Previous meta-analysis evaluating the use of neo-adjuvant chemotherapy and adjuvant chemotherapy demonstrate a similar impact on improved disease free survival (DFS) and overall survival (OS). The role of checkpoint inhibitors has been proven to be effective in the treatment of patients with advanced NSCLC, regardless of histology and PD-L1 expression. Results from trials evaluating the use of checkpoint inhibitors alone or in combination with chemotherapy in the neoadjuvant setting for early stage disease are promising. However, there are no trials evaluating the role of concomitant chemotherapy and checkpoint inhibitors in the adjuvant setting. In addition, emerging data supports the use of ctDNA as a promising biomarker for early detection of minimal residual disease and have indicated that the presence of detectable ctDNA after surgery for localized lung cancer is correlated with a 90-100% chance for disease recurrence. Therefore, we propose this current study assessing concomitant chemotherapy plus Atezolizumab in the adjuvant setting for patients with stage I (tumors ≥ 4cm), IIA, IIB (and select IIIA) NSCLC who have detectable ctDNA after surgery. The clearance of ctDNA will serve as a surrogate for long term DFS and OS in this patient population.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Squamous or non-squamous NSCLC histology. Cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus "non-squamous histology".
  • Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesLung
Participating InstitutionsIndiana University (IU)
    Roudebush VA Medical Center
      Treatment TypeTreatment
      ContactPhone: (317) 278-5632
      Email: iutrials@iu.edu