Repositioning Immunotherapy in VetArans With Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2030-03-31

Brief Summary

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This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC.

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Carboplatin, paclitaxel, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for squamous cell lung cancer) OR Carboplatin, pemetrexed, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for lung adenocarcinoma)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemoimmunotherapy followed by radiotherapy

Nivolumab (Opdivo) + plus platinum-doublet chemotherapy followed by radiotherapy

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Carboplatin, paclitaxel, and nivolumab for three cycles (for squamous cell lung cancer) or Carboplatin, pemetrexed, and nivolumab for three cycles (for lung adenocarcinoma) Followed by radiotherapy (60 Gy in 30 fractions) Followed by adjuvant nivolumab (six cycles)

Interventions

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Nivolumab

Carboplatin, paclitaxel, and nivolumab for three cycles (for squamous cell lung cancer) or Carboplatin, pemetrexed, and nivolumab for three cycles (for lung adenocarcinoma) Followed by radiotherapy (60 Gy in 30 fractions) Followed by adjuvant nivolumab (six cycles)

Intervention Type DRUG

Other Intervention Names

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Opdivo

Eligibility Criteria

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Inclusion Criteria

* Participants must be more than 18 years of age.
* Patient must have a performance status of 0-1 (ECOG Performance Scale).
* Patient must be a candidate for concurrent chemoradiation.
* Unresectable Stage III NSCLC as assessed by investigator or multidisciplinary tumor board assessment
* PD-L1 tumor expression greater than or equal to 1%
* Presence of measurable disease according to RECIST v1.1
* Adequate organ function
* Available tissue (archival FFPE preferred) with adequate tumor content ( 20% tumor cellularity).

Exclusion Criteria

* Active autoimmune disease that has requires immunosuppressive therapy in the previous year.
* Uncontrolled primary or acquired immunodeficiency (including HIV)
* Baseline corticosteroid usage (\>10 mg prednisone or equivalent daily) aside from supportive medication use.
* Tumor with known EGFR, ALK, ROS1, MET or RET mutations/fusions.
* Presence of significant comorbidities precluding participation in a clinical study as determined by investigator.
* Prior thoracic radiotherapy or prior systemic treatment for stage IIIB/IV NSCLC
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with informed consent through 180 days after the last dose of trial treatment.
* Has a known history of active TB (Bacillus Tuberculosis)
* Has known active Hepatitis B or Hepatitis C.
* Has received a live vaccine within 30 days of enrollment.
* Known diagnosis of Interstitial Lung Disease
* Inability to provide informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No