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Combination Checkpoint Inhibitor Plus Erlotinib or Crizotinib for EGFR or ALK Mutated Stage IV Non-small Cell Lung Cancer

NCT01998126 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-04-02

No results posted yet for this study

Summary

The goals of the overall study are to evaluate a recommended phase 2 dose and the short and long term toxicities of the combinations. This is a modified phase I trial of immune checkpoint inhibitors in combination with mutation - specific targeted therapy (crizotinib or erlotinib) at conventional doses stratified for presence of ALK (Anaplastic lymphoma kinase) or EGFR (epidermal growth factor receptor) mutation.

The goals of the overall study are to evaluate a recommended phase 2 dose and the short and long term toxicities of the combinations.

Conditions

Interventions

DRUG

Ipilimumab

Ipilimumab 3 mg/kg x 4 (given with standard Erlotinib or Crizotinib based on mutation)

DRUG

Erlotinib

Erlotinib 150 mg once daily or current tolerable dose (given with Ipilimumab)

DRUG

Crizotinib

Crizotinib 250 mg twice daily or current tolerable dose (given with Ipilimumab)

DRUG

Nivolumab

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-02
Primary Completion
2017-05-09
Completion
2018-03-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01998126 on ClinicalTrials.gov