Induction Chemo-Nivo in Unresectable Stage III NSCLC

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Ralph G Zinner
Study ID
NCT06003075
Phase
PHASE2
Status
Terminated

Conditions

  • Lung Cancer Stage III
  • Lung Cancer, Nonsmall Cell

Eligibility Criteria

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

Interventions

  • Nivolumab and Chemotherapy — COMBINATION_PRODUCT
    3 cycles of the proposed nivolumab + platinum doublet (either pemetrexed + carbo/cis or paclitaxel + carbo or docetaxel + carbo/cis for non squamous; or gemcitabine + carbo/cis or paclitaxel + carbo or docetaxel + carbo/cis for squamous) will be administered then CT and biopsy, followed by surgery with option for post-op NIVO-XRT, then 12 cycles NIVO at 480 mg IV every 4 weeks for 12 weeks
  • Nivolumab — DRUG
    Participants will receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation
  • Post Induction Surgery — PROCEDURE
    Induction Chemo-NIVO x 3 cycles then CT and biopsy, followed by surgery in patients whose tumors were unresectable stage IIIA-C at baseline on the basis of lymphadenopathy and are determined to be resectable after responding to induction chemotherapy-nivolumab. The participants have an option for post op XRT, then will receive NIVO at 480 mg IV every 4 weeks for 12 cycles
  • Post Induction XRT — RADIATION
    Induction Chemo-NIVO x 3 cycles then CT and biopsy, followed by concurrent Chemo and Nivo XRT (60Gy). Participants will receive concurrent thoracic radiation therapy using a standardized 3DCRT or IMRT technique on a linear accelerator operating at 2:6 MV beam energy. The target total dose of thoracic radiation therapy will be 60 Gy in 30 daily fractions of 2 Gy prescribed to the PTV. The participants then will receive NIVO at 480 mg IV every 4 weeks for 12 cycles.

Study Details

The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.

Key Dates

First listed
Aug 21, 2023
Start date
Dec 13, 2023
Status verified
Apr 2025
Primary completion
Jul 5, 2024
Completion
Jul 5, 2024

Study Design

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

Arms

  • Experimental: Combination Chemotherapy and Nivolumab and Surgery
    Patients with lung cancer receiving combination therapy with surgery
  • Experimental: Combination Chemotherapy and Nivolumab and Radiation
    Patients with lung cancer receiving combination therapy with radiation

Primary Outcome Measure

Response Rate After Induction [ Time Frame: 9 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506-

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By research site
University of Kentucky· Lexington, KY

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