NCT04625699

Study of Durvalumab + Tremelimumab in NSCLC Patients After Adjuvant Treatment

A Feasibility Study of Durvalumab + Tremelimumab in Resected Non Small Cell Lung Cancer (NSCLC) Patients With Detectable Circulating Tumor DNA After Adjuvant Treatment

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Catherine Shu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether it is feasible and safe to give research participants investigational treatment with durvalumab and tremelimumab after they have completed standard treatment for NSCLC and once they have detectable circulating tumor DNA (ctDNA) in the blood before there is evidence of disease recurrence on imaging studies. These investigational agents are a type of immunotherapy, which is a treatment that activates your own body's immune system to treat cancer.

Detailed description

This is an open label, single arm, pilot study of adjuvant durvalumab+ tremelimumab (D+T) for patients with stage II-IIIB (excluding N3) NSCLC.The trial will evaluate the feasibility of adjuvant D+T in patients who have undergone surgical resection and standard of care (SOC) adjuvant treatment and subsequently develop detectable plasma ctDNA. 15 evaluable patients will be enrolled. Patients with resected stage II-IIIB (excluding N3) NSCLC who have completed adjuvant standard of care treatment will be pre-screened and consented for the trial. They will undergo ctDNA testing with the Signatera assay at the completion of adjuvant treatment and every 4 months thereafter with standard CT imaging assessment up to 1 year. Patients with detectable ctDNA at a mutant allele frequency of \>0.1% and no evidence of recurrence on CT imaging will be enrolled in the trial. They will receive durvalumab every 4 weeks for 4 cycles and tremelimuamb on cycles 1 and 3 with concomitant plasma ctDNA quantification. Patients will be followed with standard CT imaging of the chest as well as routine and exploratory blood tests every 4 months until 1 year after completion of D+T. They will also be followed for up to 3 years for determination of DFS and OS.

Conditions

• Nonsmall Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	4 doses of Durvalumab 1500 mg IV Day 1, q28 days (For example, interventions involving drugs may include dosage form, dosage, frequency, and duration.)
DRUG	Tremelimumab	2 doses of Tremelimumab 300 mg IV Day 1, q56 days

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-07-01
• Completion: 2023-12-01
• First posted: 2020-11-12
• Last updated: 2023-06-06

Regulatory

• FDA-regulated drug study