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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-15

Study Completion Date

2023-10-18

Brief Summary

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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

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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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Nivolumab 360 mg

Intervention Type DRUG

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

Paclitaxel 200mg/m2

Intervention Type DRUG

Paclitaxel 200mg/m2 IV Q3W

Carboplatin AUC 6

Intervention Type DRUG

Carboplatin AUC 6 IV Q3W

Interventions

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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

Intervention Type DRUG

Paclitaxel 200mg/m2

Paclitaxel 200mg/m2 IV Q3W

Intervention Type DRUG

Carboplatin AUC 6

Carboplatin AUC 6 IV Q3W

Intervention Type DRUG

Other Intervention Names

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OPDIVO Paclitaxel Carboplatin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariano Provencio, MD

Role: STUDY_CHAIR

spanish Lun Cancer Group

Valencia, , Spain

Site Status

Countries

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Spain

Reference Type DERIVED

PMID: 34323406 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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GECP 16/03_NADIM

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Arm 1

Nivolumab 360 mg

Paclitaxel 200mg/m2

Carboplatin AUC 6

Interventions

Nivolumab 360 mg

Paclitaxel 200mg/m2

Carboplatin AUC 6

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Spanish Lung Cancer Group

Responsible Party

Principal Investigators

Mariano Provencio, MD

Locations

Complejo hospitalario de la coruña

Hospital Reina Sofía

Hospital Insular de Gran Canaria

Hospital Puerta de Hierro

Clínica Universitaria de Navarra

Complejo Hospitalario de Vigo

Hospital de Cruces

Hospital General de Alicante

Hospital Universitari Quirón Dexeus

Hospital Universitari Vall Hebrón

Hospital Clínic de Barcelona

Hospital de La Santa Creu I Sant Pau

H. Duran i Reynals-ICO

H. de la Princesa

Hospital Clínico San Carlos

Hospital Fundación Jiménez Díaz

H. La Paz

Hospital Son Espases

Hospital Clinico de Salamanca

Hospital Virgen de La Macrena

Hospital Virgen Del Rocío

Hospital Clínico Universitario de Valencia

H. Gen. Univ. Valencia

Hospital La Fe

Countries

References

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

Related Links

Other Identifiers

GECP 16/03_NADIM