A phase II trial evaluating the safety and efficacy of the addition of concurrent anti-PD-1 nivolumab to standard first-line chemotherapy and radiotherapy in locally advanced stage IIIA/B Non-Small Cell Lung Carcinoma - NICOLAS

ETOP (European Thoracic Oncology Platform)0 sites78 target enrollmentMay 12, 2015

Conditionslocally advanced stage IIIA/B NSCLC MedDRA version: 20.0Level: PTClassification code 10029520Term: Non-small cell lung cancer stage IIIASystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: locally advanced stage IIIA/B NSCLC
Sponsor: ETOP (European Thoracic Oncology Platform)
Enrollment: 78
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 12, 2015

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ETOP (European Thoracic Oncology Platform)

Eligibility Criteria

Inclusion Criteria

•\- Histologically or cytologically confirmed non small cell lung carcinoma
•\- Locally advanced stage IIIA or III B (T0\-3 N2\-3 or T4N0\-3 M0\) NSCLC, according to 7th TNM classification.
•Within 35 days before beginning of first platinum\-based chemotherapy cycle:
•\- Nodal status N2 or N3 must be proven (by biopsy, EBUS, mediastinoscopy or thoracoscopy) except for overt cT4 disease.
•\- Whole body FDG\-PET CT plus contrast enhanced CT of thorax / upper abdomen (from top of thorax until adrenal glands, and full liver and kidney included) in addition to or in combination with PET.
•\- brain MRI (preferred) or high\-quality brain CT with intravenous contrast at the time of staging mandatory
•within 28 days before enrolment.
•\- Measurable disease (according to RECIST v1\.1 criteria)
•\- Age: equal or greater than 18 years
•\- Eastern Cooperative Oncology Group (ECOG) Performance Status 0\-1 (see Table 1\)

Exclusion Criteria

•\- Patient with mixed small\-cell and non\-small\-cell histologic features
•\- Patient with pleural or pericardial effusions proven to be malignant
•\- Prior chemotherapy, radiotherapy or molecular targeted therapy for NSCLC (with the exception of one cycle of chemotherapy given prior to enrolment into this trial, see 7\.1\.7\)
•\- Patient with an active, known or suspected autoimmune disease. Patients are permitted to enrol if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
•\- Patient who has had in the past 3 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast.
•\- Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient?s capacity to participate in the trial..
•\- Ongoing clinically serious infections requiring systemic antibiotic or antiviral, antimicrobial, antifungal therapy.
•\- Known or suspected hypersensitivity to nivolumab or any of its excipients
•\- History of severe hypersensitivity reaction to any monoclonal antibody
•\- Substance abuse, medical, psychological or social conditions that may interfere with the patient\`s participation in the trial or evaluation of the trial results.