Status: Active Trial | Marker: no marker

Title

A phase II trial of nivolumab in combination with ipilimumab to evaluate efficacy and safety in relapsed lung cancer and to evaluate biomarkers predictive for response to immune checkpoint inhibition.

Study Number
NCT03083691
Indication

Cohort 1: Subjects with histologically or cytologically confirmed advanced non-squamous non-small cell lung cancer who present with stage IIIB/IV disease after failure of platinum-based first-line therapy (second line) – recruitment of cohort 1 is stopped

Cohort 2: Subjects with histologically or cytologically confirmed limited-stage or extensive-stage small cell lung cancer and high tumor mutation burden after failure of platinum-based first-line therapy (second line).

Primary objective

Cohort 1:
To assess ORR when ipilimumab is added to nivolumab after progression on nivolumab monotherapy in patients relapsed with non-squamous NSCLC (second line).

Cohort 2:
To assess ORR of the combination therapy of ipilimumab and nivolumab in patients with relapsed SCLC and high tumor mutation burden (second line).

In- and exclusion Criteria

Inclusion:
Cohort 1: Subjects with histologically or cytologically confirmed advanced non-squamous non-small cell lung cancer who present with stage IIIB/IV disease after failure of platinum-based first-line therapy (second line).
Cohort 2: Subjects with histologically or cytologically confirmed limited-stage or extensive-stage small cell lung cancer after failure of platinum-based first-line therapy (second line) and high tumor mutation burden.
Subjects must be willing to undergo at least 2 biopsies (baseline and before the second treatment part).

Exclusion:
• Subjects with squamous cell NSCLC
• Active brain metastases or leptomeningeal metastases
• Subjects with active, known or suspected autoimmune disease. Subjects 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

Study design
phase II, open label
Responsibilities

LCGC – University Hospital of Cologne

Trial Centre

University Hospital of Cologne
Dep. I of Internal Medicine / LCGC
Phone: +49 221 478 87008
Fax: +49 221 478 87010
lungenkrebs@uk-koeln.de

Principal investigator

Prof. J. Wolf

Last Update: 11. April 2019