Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03237377
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    1500mg via IV infusion every 4 weeks for up to 3 doses/cycles
  • Tremelimumab — DRUG
    75mg via IV infusion every 4 weeks
  • Thoracic Radiation — RADIATION
    5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction
  • lobectomy — PROCEDURE
    patients may proceed to surgery post drug and radiation intervention for lung lobectomy
  • Standard of care adjuvant chemotherapy — DRUG
    patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery

Study Details

This is a pilot study of neoadjuvant 'immunoradiation' (durvalumab or durvalumab plus tremelimumab) administered every 4 weeks for 2 doses, concurrently with standard thoracic radiation (RT) (45Gy in 25 fractions), with one dose of immunotherapy alone delivered in the pre-surgical window, prior to surgical resection, for patients with stage IIIA NSCLC that is deemed resectable with a lobectomy by a thoracic surgeon. If preliminary safety of the durvalumab/thoracic RT combination is established, a second cohort investigating the combination of durvalumab/tremelimumab/thoracic RT prior to surgical resection will be opened. After surgical resection, patients may receive standard adjuvant chemotherapy, as deemed appropriate by the treating investigator.

Key Dates

Start date
Dec 12, 2017
Status verified
May 2026
Primary completion
Nov 4, 2021
Completion
May 23, 2024

Study Design

Enrollment
9 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab with Radiation
    Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery
  • Experimental: Durvalumab and Trememlimumab with Radiation
    Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery

Primary Outcome Measure

Toxicities as Measured by Number of Participants Experiencing Adverse Events [ Time Frame: 3 months post surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224-

Find similar trials in Baltimore, MD

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Johns Hopkins Bayview Medical Center· Baltimore, MD

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