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History of Changes for Study: NCT03081689
Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients
Latest version (submitted January 17, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 10, 2017 None (earliest Version on record)
2 March 20, 2017 Arms and Interventions, Eligibility and Study Status
3 April 25, 2017 Recruitment Status, Contacts/Locations and Study Status
4 April 24, 2018 Contacts/Locations, Study Status and Study Identification
5 September 5, 2018 Study Status and Contacts/Locations
6 November 12, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
7 April 3, 2019 Study Status
8 September 20, 2019 Study Status
9 November 22, 2019 Study Status, Eligibility and Study Description
10 February 1, 2021 Study Status
11 September 21, 2021 Study Status
12 September 21, 2022 Study Status
13 January 9, 2023 Study Status
14 January 17, 2024 Recruitment Status and Study Status
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Study NCT03081689
Submitted Date:  March 10, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: GECP 16/03_NADIM
Brief Title: Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients
Official Title: NEO -ADJUVANT CHEMO/IMMUNOTHERAPY FOR THE TREATMENT OF RESECTABLE STAGE IIIA NON SMALL CELL LUNG CANCER (NSCLC): A PHASE II MULTICENTER EXPLORATORY STUDY
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2017
Overall Status: Not yet recruiting
Study Start: April 15, 2017
Primary Completion: June 30, 2021 [Anticipated]
Study Completion: June 30, 2022 [Anticipated]
First Submitted: March 10, 2017
First Submitted that
Met QC Criteria:
March 10, 2017
First Posted: March 16, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
March 10, 2017
Last Update Posted: March 16, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Spanish Lung Cancer Group
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
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 are allowed to leave the study if there is evidence of progression. These patients may be considered for surgery.

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.

Open or close this module Conditions
Conditions: Non Small Cell Lung Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 46 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 10 MG/ML
Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Secondary Outcome Measures:
1. Overall survival
[ Time Frame: at 3 years from the first dose of neoadjuvant treatment ]

Time when the patient is still alive
2. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. The subjects eligible for the study are those with histologically- or cytologically- documented NSCLC who present stage IIIA disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated
  2. Tumor should be considered resectable before study entry by a multidisciplinary team
  3. Performance Status of 0 or 1 if using ECOG/Zubrod
  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

a. 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. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters ix. INR/APTT within normal limits

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

Age and Reproductive Status

6. Patients aged > 18 years

7. Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab 8. Women must not be breastfeeding 9. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception)

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. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included.
  3. Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  4. Patients with a history of interstitial lung disease cannot be included if they have sympthomatic ILD (Grade 3-4) and/or poor lung function. In case of doubt please contact trial team.
  5. Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anti-cancer therapy
  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 complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
  7. Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
  8. Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
  9. Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
  10. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  11. Patients with history of allergy to study drug components excipients
Open or close this module Contacts/Locations
Central Contact Person: Eva Pereira
Telephone: 93 430 20 06
Email: epereira@gecp.org
Central Contact Backup: Maria Fernández
Telephone: 93 430 20 06
Email: secretaria@gecp.org
Study Officials: Mariano Provencio, MD
Study Chair
spanish Lun Cancer Group
Locations: Spain
Hospital General de Alicante
Alicante, Spain, 03010
Contact:Contact: Bartomeu Massutí, MD-phD
Contact:Principal Investigator: Bartomeu Massutí
Hospital Universitari Quirón Dexeus
Barcelona, Spain, 08028
Contact:Contact: Santiago Viteri, MD-PhD
Contact:Principal Investigator: Santiago Viteri
Hospital Universitari Vall Hebrón
Barcelona, Spain, 08035
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Contact:Contact: Nuria Viñolas, MD
Contact:Principal Investigator: Nuria Viñolas
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08041
Contact:Contact: Margarita Majem, MD-PhD
Contact:Principal Investigator: Margarita Majem
H. Duran i Reynals-ICO
Barcelona, Spain, 08907
Contact:Contact: Ernest Nadal, MD +34932607332
Contact:Principal Investigator: Ernest Nadal, MD
Hospital Insular de Gran Canaria
Gran Canaria, Spain, 35016
H. de la Princesa
Madrid, Spain, 28006
Contact:Contact: José Miguel Sánchez, MD +34915202479
Contact:Principal Investigator: José Miguel Sánchez, MD
Hospital Clínico San Carlos
Madrid, Spain, 28040
Contact:Contact: José Luis González Larriba, MD
Contact:Principal Investigator: José Luis González Larriba
Hospital Fundación Jiménez Díaz
Madrid, Spain, 28040
Contact:Contact: Manuel Dómine, MD
Contact:Principal Investigator: Manuel Dómine
H. La Paz
Madrid, Spain
Contact:Contact: Javier de Castro, MD
Contact:Principal Investigator: Javier de castro, MD
H. Carlos Haya
Málaga, Spain, 29010
Contact:Contact: Manuel Cobo, MD +34951290000
Contact:Principal Investigator: Manuel Cobo, MD
Hospital Son Espases
Palma de Mallorca, Spain, 07010
Contact:Contact: Mónica Guillot, MD
Contact:Principal Investigator: Mónica Guillot
Hospital Clinico de Salamanca
Salamanca, Spain, 37007
Contact:Contact: Elvira del Barco, MD
Contact:Principal Investigator: Elvira del Barco, MD
Hospital Virgen de La Macrena
Sevilla, Spain, 41009
Contact:Contact: David Vicente, MD
Contact:Principal Investigator: David Vicente
Hospital Virgen Del Rocío
Sevilla, Spain, 41013
Contact:Contact: Reyes Bernabé, MD
Contact:Principal Investigator: Reyes Bernabé
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Contact:Contact: Amelia Insa, MD
Contact:Principal Investigator: Amelia Insa
H. Gen. Univ. Valencia
Valencia, Spain
Contact:Contact: Carlos Camps, MD
Contact:Principal Investigator: Carlos Camps, MD
Hospital La Fe
Valencia, Spain
Contact:Contact: José Codina
Contact:Principal Investigator: José Codina
Spain, Coruña
Complejo hospitalario de la coruña
La Coruña, Coruña, Spain, 15006
Spain, Córdoba
Hospital Reina Sofía
Cordoba, Córdoba, Spain, 14004
Contact:Contact: Isidoro Barneto, MD
Contact:Principal Investigator: Isidoro Barneto
Spain, Madrid
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Contact:Contact: Mariano Provencio, MD
Contact:Principal Investigator: Mariano Provencio
Spain, Navarra
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Contact:Contact: Ignacio Gil-Bazo, MD
Contact:Principal Investigator: Ignacio Gil-Bazo
Spain, Pontevedra
Complejo Hospitalario de Vigo
Vigo, Pontevedra, Spain, 36212
Contact:Contact: Joaquin Casal, MD
Contact:Principal Investigator: Joaquin Casal
Spain, Vizcaya
Hospital de Cruces
Bilbao, Vizcaya, Spain, 48903
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links: Description: Web page of the sponsor where users can find more information about SLCG studies
Available IPD/Information:

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