Adjuvant Treatment With Cisplatin-based Chemotherapy Plus Concomitant Atezolizumab in Patients With Stage I (Tumors ≥ 4cm), IIA, IIB, and Select Stage III [Any T1-3 N1-2 and T4N0-2] Resected Non-small Cell Lung Cancer (NSCLC) and the Clearance of Circulating Tumor DNA (ctDNA)

Conditions

• Lung Cancer
• NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Atezolizumab 1200 mg
• Docetaxel — DRUG
  Docetaxel 60-75 mg/m\^2
• Cisplatin — DRUG
  60-75 mg/m\^2
• Pemetrexed — DRUG
  Pemetrexed 500mg/m\^2

Study Details

The vast majority of patients with stage I (tumors ≥ 4cm), IIA, IIB (and select stage III) 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 stage III) 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 Dates

Start date

May 22, 2020

Status verified

Dec 2025

Primary completion

Aug 6, 2024

Completion

Mar 31, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: NSC: Non-squamous cell tumors
  Atezolizumab 1200mg, Pemetrexed 500 mg/m\^2, Cisplatin 60-75 mg/m\^2
• Experimental: SC: Squamous cell tumors
  Atezolizumab 1200mg, Docetaxel 60-75 mg/m\^2, Cisplatin 60-75 mg/m\^2

Primary Outcome Measure

Percentage of patients with undetectable ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab plus up to 13 additional cycles of Atezolizumab in patients with stage I (tumors ≥ 4cm), IIA, IIB, and select stage III [any T1-3 N1-2 and T4N0-2] [ Time Frame: Up to 17 cycles (13 months) ]

Locations (9)

Find similar trials in Chicago, IL

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