Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients

January 17, 2024 updated by: Spanish Lung Cancer Group

Neo - Adjuvant Chemo / Immunotherapy for the Treatment of Resectable Stage IIIA Non Small Cell Lung Cancer (NSCLC): A Phase II Multicenter Exploratory Study

Phase II, single-arm, open-label multicenter study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase II, single-arm, open-label multicenter study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months.

Three cycles of neoadjuvant chemotherapy in combination with nivolumab will be administered.

After completion of neoadjuvant therapy (3 cycles) and before surgery, a tumor assessment will be done. Patients have to leave the study if there is evidence of progression. Patients with in-stable disease or partial response may be considered for surgery.

The report imaging response vs pathological response rate will be evaluated.

Patients eligible for the trial are those with a histological diagnosis or cytologically proven operable and resectable non-small-cell lung cancer. The total number of patients to be included will be 46 from 23 participating sites in Spain.

Accrual period of 1.5 years or until the inclusion of the last patient necessary to achieve the sample set in the protocol of 46 patients. After that all patients will be treated for 1 year with adjuvant immunotherapy and they will be followed during 3 years after adjuvant treatment.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Hospital General de Alicante
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall Hebrón
      • Barcelona, Spain, 08028
        • Hospital Universitari Quiron Dexeus
      • Barcelona, Spain, 08907
        • H. Duran i Reynals-ICO
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28040
        • Hospital Fundación Jiménez Díaz
      • Madrid, Spain
        • H. La Paz
      • Madrid, Spain, 28006
        • H. de la Princesa
      • Palma de Mallorca, Spain, 07010
        • Hospital son Espases
      • Salamanca, Spain, 37007
        • Hospital Clinico de Salamanca
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Sevilla, Spain, 41009
        • Hospital Virgen de La Macrena
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain
        • H. Gen. Univ. Valencia
      • Valencia, Spain
        • Hospital la Fe
    • Coruña
      • La Coruña, Coruña, Spain, 15006
        • Complejo hospitalario de la coruña
    • Córdoba
      • Cordoba, Córdoba, Spain, 14004
        • Hospital Reina Sofia
    • Gran Canaria
      • Las Palmas De Gran Canaria, Gran Canaria, Spain, 35016
        • Hospital Insular de Gran Canaria
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Puerta de Hierro
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clínica Universitaria de Navarra
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36212
        • Complejo Hospitalario de Vigo
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48903
        • Hospital de Cruces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The subjects eligible for the study are those with histologically- or cytologically- documented NSCLC who present stage IIIA disease. Locally advanced patients who present stage IIIA by the previous version can be included if are considered potencially resectable. In case of N2 disease suspicion, pathological assessment by EBUS, mediastinoscopy or thoracotomy has to be carried out for N2 confirmation.
  2. Tumor should be considered resectable before study entry
  3. Performance Status of 0 or 1
  4. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to registration/inclusion i. WBC ≥ 2000/μL ii. Neutrophils ≥ 1500/μL iii. Platelets ≥ 100 x103/μL iv. Hemoglobin > 9.0 g/dL v. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below): a. Female CrCl = (140 - age in years) x weight in kg x 0.85

1. 72 x serum creatinine in mg/dL

b. Male CrCl = (140 - age in years) x weight in kg x 1.00

  1. 72 x serum creatinine in mg/dL vi. AST/ALT ≤ 3 x ULN vii. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) viii. INR/APTT within normal limits

    5. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters

    6. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and nacional guidelines, including the Declaration of Helsinki prior to any trial-related intervention.

    7. Patients aged > 18 years

    8. Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception.

    9. Women must not be breastfeeding

    10. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year.

    Exclusion Criteria:

    1. All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.
    2. Patients with active, known or suspected autoimmune disease.
    3. Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
    4. Patients with a history of interstitial lung disease cannot be included if they have sympthomatic ILD (Grade 3-4)
    5. Patients with other active malignancy requiring concurrent intervention
    6. Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a
    7. Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study
    8. Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody,
    9. Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody)
    10. Patients with known history of testing positive for human immunodeficiency virus (HIV)
    11. Patients with history of allergy to study drug components excipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Drug: Nivolumab 360 mg
Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Other Names:
  • OPDIVO
Drug: Paclitaxel 200mg/m2
Paclitaxel 200mg/m2 IV Q3W
Other Names:
  • Paclitaxel
Drug: Carboplatin AUC 6
Carboplatin AUC 6 IV Q3W
Other Names:
  • Carboplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: at 24 months from the first dose of neadjuvant treatment
The progression free survival is the time until the patients disease progresses
at 24 months from the first dose of neadjuvant treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: at 3 years from the first dose of neoadjuvant treatment
Time when the patient is still alive
at 3 years from the first dose of neoadjuvant treatment
Toxicity profile
Time Frame: from the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment
Toxicities caused by the drug during the study
from the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Lung Cancer Group

Investigators

  • Study Chair: Mariano Provencio, MD, spanish Lun Cancer Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2017

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

October 18, 2023

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 10, 2017

First Posted (Actual)

March 16, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GECP 16/03_NADIM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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