Feasibility and Safety of Nintedanib in Combination With Nivolumab in Pretreated Patients With Advanced or Metastatic NSCLC of Adenocarcinoma Histology

Conditions

• Adenocarcinoma of the Lung

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• nintedanib-nivolumab combination therapy — DRUG
  Safety run-in - Dose finding stage The safety-run in phase will be designed as a standard 3+3 design for dose escalation/de-escalation and 3 to 6 patients will be enrolled in each cohort sequentially, depending on occurrence of dose limiting toxicities. The recommended phase 2 dose (RP2D) will be the highest dose in which the frequency of DLTs is less than 33% if no other safety or feasibility considerations prevail. Expansion phase: Nintedanib RP2D + nivolumab 240 mg Q2W until progression of disease.

Study Details

Determination of a safe dose for nintedanib+nivolumab combination therapy and the generation of exploratory efficacy data in pretreated patients with advanced or metastatic NSCLC of adenocarcinoma histology.

Key Dates

Start date

May 25, 2018

Status verified

Feb 2024

Primary completion

May 23, 2023

Completion

Sep 15, 2023

Study Design

Enrollment

56 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: nintedanib nivolumab
  nintedanib-nivolumab combination therapy

Primary Outcome Measure

Safety and tolerability as determined by frequency and severity of adverse events [ Time Frame: 47 months ]