Tremelimumab and Durvalumab With or Without Radiation Therapy in Patients With Relapsed Small Cell Lung Cancer

Conditions

• Recurrent Small Cell Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — BIOLOGICAL
  Given IV
• Hypofractionated Radiation Therapy — RADIATION
  Undergo hypofractionated radiation therapy
• Stereotactic Body Radiation Therapy — RADIATION
  Undergo SBRT
• Tremelimumab — BIOLOGICAL
  Given IV

Study Details

This randomized clinical trial studies how well tremelimumab and durvalumab with or without radiation therapy works in treating patients with small cell lung cancer that has returned after a period of improvement. Monoclonal antibodies, such as tremelimumab and durvalumab, may limit the ability of tumor cells to grow and spread by enhancing immune function. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving tremelimumab and durvalumab together with radiation therapy may lead to improved clinical benefit.

Key Dates

Start date

Apr 14, 2016

Status verified

May 2021

Primary completion

Aug 7, 2020

Completion

Aug 7, 2020

Study Design

Enrollment

18 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (tremelimumab, durvalumab)
  Patients receive tremelimumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive durvalumab IV over 1 hour on day 1. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving disease control may restart treatment upon evidence of progressive disease, with or without confirmation.
• Active Comparator: Arm II (RT, tremelimumab, durvalumab)
  Patients undergo stereotactic body radiation therapy (SBRT) or hypofractionated radiation therapy daily for 5 days over 1 week or for 3 fractions every other day for 1 week and then receive the same treatment as in Arm I.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From initiation of systemic therapy to first documented disease progression, assessed through study completion, up to 2 years ]

Locations (2)

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