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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 January 2024
• Main ID: NCT03081689
• Date of registration: 10/03/2017
• Prospective Registration: Yes
• Primary sponsor: Spanish Lung Cancer Group
• Public title: Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients
• Scientific title: Neo - Adjuvant Chemo / Immunotherapy for the Treatment of Resectable Stage IIIA Non Small Cell Lung Cancer (NSCLC): A Phase II Multicenter Exploratory Study
• Date of first enrolment: April 15, 2017
• Target sample size: 46
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03081689
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Spain

Contacts

• Name: Mariano Provencio, MD
• Affiliation: spanish Lun Cancer Group

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non Small Cell Lung Cancer

Intervention(s)

Drug: Paclitaxel 200mg/m2

Drug: Carboplatin AUC 6

Drug: Nivolumab 360 mg

Primary Outcome(s)

Progression free survival [Time Frame: at 24 months from the first dose of neadjuvant treatment]

Secondary Outcome(s)

Toxicity profile [Time Frame: from the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment]

Overall survival [Time Frame: at 3 years from the first dose of neoadjuvant treatment]

Secondary ID(s)

GECP 16/03_NADIM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors