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Survival Prolongation by Rationale Innovative Genomics

NCT03386929 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-12-18

Study results available
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Summary

Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, ROS1 mutation if available or MET exon 14 skipping mutation if available) will receive a tri-therapy associating avelumab, axitinib and palbociclib.

Conditions

  • Non-small Cell Lung Cancer Metastatic
  • Non-small Cell Lung Cancer Stage IIIB

Interventions

DRUG

Avelumab

A human antibody of the immunoglobulin gamma-1 isotype that specifically targets and blocks the Programmed Death ligand (PD-L1) for PD-1.

DRUG

Axitinib

A selective oral (tablet) inhibitor of tyrosine kinases Vascular Endothelial Growth Factor (VEGF) receptors 1, 2, and 3. These receptors are implicated in pathologic angiogenesis, tumor growth and cancer progression.

DRUG

Palbociclib

A selective, reversible oral (capsule) inhibitor of cyclin-dependent kinases (CDK) 4 and 6. The inhibition of CDK 4/6 blocks DNA synthesis by prohibiting progression of the cell cycle from G1 to S phase.

Sponsors & Collaborators

  • ARC Foundation for Cancer Research

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Worldwide Innovative Network Association

    lead OTHER

Principal Investigators

  • RAZELLE KURZROCK, MD · Medical College of Wisconsin, Milwaukee, WI, USA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2022-12-29
Completion
2022-12-29
FDA Drug
Yes

Countries

  • United States
  • Israel
  • Luxembourg
  • Spain

Study Locations

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Entities

Drugs
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 NCT03386929 on ClinicalTrials.gov