Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03081689|
Recruitment Status : Active, not recruiting
First Posted : March 16, 2017
Last Update Posted : January 10, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Nivolumab 360 mg Drug: Paclitaxel 200mg/m2 Drug: Carboplatin AUC 6||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 15, 2017|
|Estimated Primary Completion Date :||September 15, 2024|
|Estimated Study Completion Date :||September 30, 2024|
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 Name: OPDIVO
Drug: Paclitaxel 200mg/m2
Paclitaxel 200mg/m2 IV Q3W
Other Name: Paclitaxel
Drug: Carboplatin AUC 6
Carboplatin AUC 6 IV Q3W
Other Name: Carboplatin
- 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
- Overall survival [ Time Frame: at 3 years from the first dose of neoadjuvant treatment ]Time when the patient is still alive
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081689
|Study Chair:||Mariano Provencio, MD||spanish Lun Cancer Group|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Spanish Lung Cancer Group|
|Other Study ID Numbers:||
|First Posted:||March 16, 2017 Key Record Dates|
|Last Update Posted:||January 10, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors