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

NCT04046614 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-02-06

No results posted yet for this study

Summary

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.

Conditions

  • Adenocarcinoma of the Lung

Interventions

DRUG

nintedanib-nivolumab combination therapy

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.

Sponsors & Collaborators

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Martin Reck, Prof. Dr. · LungenClinic Grosshansdorf GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-25
Primary Completion
2023-05-23
Completion
2023-09-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04046614 on ClinicalTrials.gov