History of Changes for Study: NCT03081689

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

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Study Record Versions

Version	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

Comparison Format:

Merged
Side-by-Side

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:

Study Status


Record Verification:	November 2019
Overall Status:	Active, not 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:	November 22, 2019
Last Update Posted:	November 26, 2019 [Actual]

Sponsor/Collaborators


Sponsor:	Spanish Lung Cancer Group
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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:

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.

Conditions


Conditions:	Non Small Cell Lung Cancer
Keywords:

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 [Actual]

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 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

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

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: 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. Tumor should be considered resectable before study entry Performance Status of 0 or 1 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 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: All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene. Patients with active, known or suspected autoimmune disease. Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Patients with a history of interstitial lung disease cannot be included if they have sympthomatic ILD (Grade 3-4) Patients with other active malignancy requiring concurrent intervention 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 Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) Patients with known history of testing positive for human immunodeficiency virus (HIV) Patients with history of allergy to study drug components excipients

Contacts/Locations


Study Officials:	Mariano Provencio, MD Study Chair spanish Lun Cancer Group
Locations:	Spain
	Hospital General de Alicante Alicante, Spain, 03010
	Hospital Universitari Quirón Dexeus Barcelona, Spain, 08028
	Hospital Universitari Vall Hebrón Barcelona, Spain, 08035
	Hospital Clínic de Barcelona Barcelona, Spain, 08036
	Hospital de La Santa Creu I Sant Pau Barcelona, Spain, 08041
	H. Duran i Reynals-ICO Barcelona, Spain, 08907
	H. de la Princesa Madrid, Spain, 28006
	Hospital Clínico San Carlos Madrid, Spain, 28040
	Hospital Fundación Jiménez Díaz Madrid, Spain, 28040
	H. La Paz Madrid, Spain
	Hospital Son Espases Palma de Mallorca, Spain, 07010
	Hospital Clinico de Salamanca Salamanca, Spain, 37007
	Hospital Virgen de La Macrena Sevilla, Spain, 41009
	Hospital Virgen Del Rocío Sevilla, Spain, 41013
	Hospital Clínico Universitario de Valencia Valencia, Spain, 46010
	H. Gen. Univ. Valencia Valencia, Spain
	Hospital La Fe Valencia, Spain
	Spain, Coruña
	Complejo hospitalario de la coruña La Coruña, Coruña, Spain, 15006
	Spain, Córdoba
	Hospital Reina Sofía Cordoba, Córdoba, Spain, 14004
	Spain, Gran Canaria
	Hospital Insular de Gran Canaria Las Palmas De Gran Canaria, Gran Canaria, Spain, 35016
	Spain, Madrid
	Hospital Puerta de Hierro Majadahonda, Madrid, Spain, 28222
	Spain, Navarra
	Clínica Universitaria de Navarra Pamplona, Navarra, Spain, 31008
	Spain, Pontevedra
	Complejo Hospitalario de Vigo Vigo, Pontevedra, Spain, 36212
	Spain, Vizcaya
	Hospital de Cruces Bilbao, Vizcaya, Spain, 48903

IPDSharing


Plan to Share IPD:	No

References


Links:	URL: http://www.gecp.org Description: Web page of the sponsor where users can find more information about SLCG studies
Available IPD/Information: