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

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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