Study of Durvalumab + Tremelimumab in NSCLC Patients After Adjuvant Treatment

Sponsor
Catherine Shu
Study ID
NCT04625699
Phase
PHASE2
Status
Withdrawn

Conditions

  • Nonsmall Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 31, 2022
Status verified
Jun 2023
Primary completion
Jul 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: durvalumab+ tremelimumab
    durvalumab will be administered Q4weeks and tremelimumab will be administered Q8 weeks

Primary Outcome Measure

Number of evaluable patients enrolled [ Time Frame: 36 months ]

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