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

Phase 2

Completed

Conditions: locally advanced non-small cell lung cancer
10038666
10029107

Registration Number: NL-OMON44704

Lead Sponsor: European Thoracic Oncology Platform (ETOP)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

* Histologically or cytologically confirmed locally advanced stage IIIA or III B (T0-3, N2-3 or T4 N0-3 M0) non-small cell lung carcinoma (NSCLC), according to 7th TNM classification.
* Nodal status N2 or N3 need to be proven (by biopsy, EBUS, mediastinoscopy or thoracoscopy) except for overt cT4 disease.
* Measurable disease according to RECIST v1.1.
* Previous delivery of a maximum of one 3-weekly cycle of platinum-based chemotherapy.
* ECOG performance status 0-1.
* Adequate hepatic, haematological and renal function.
* All AEs from previous therapies (including the first chemotherapy cycle in the context of this trial) resolved to grade <2 (except fatigue, alopecia, nausea lack of appetite or peripheral neuropathy)

Exclusion Criteria

* Metastatic disease (as determined by PET-CT and brain MRI (preferred) or highquality brain CT with intravenous contrast at the time of staging, performed within 28 days before the beginning of first chemotherapy cycle).
* Previous radiotherapy to the chest, including radiotherapy for breast cancer.
* Prior chemotherapy, radiotherapy or molecular targeted therapy for NSCLC (with the exception of one cycle of chemotherapy given prior to enrolment into this trial).
* Active, known or suspected autoimmune disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>Grade *3 pneumonitis (CTCAE V4.0) observed any time during 6 months from end of<br /><br>radiotherapy; for definition, see section 14.1.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Progression-free survival by RECIST v1.1<br /><br>* Time to first grade 3 pneumonitis<br /><br> Objective response determined by RECIST v1.1<br /><br>* Time to treatment failure<br /><br>* Overall survival<br /><br>* Adverse events graded according to CTCAE V4.0</p><br>