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Lung-MAP: Palbociclib as Second-Line Therapy in Treating Cell Cycle Gene Alteration Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer

NCT02785939 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2021-05-27

Study results available
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Summary

This phase II/III trial studies how well palbociclib works in treating cell cycle gene alteration positive patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a sub-study that includes all screened patients positive for cell cycle gene alterations which can cause tumor cells to grow more quickly. Palbociclib may slow cell cycle progression and may be able to shrink tumors.

Conditions

  • CCND1 Gene Amplification
  • CCND2 Gene Amplification
  • CCND3 Gene Amplification
  • CDK4 Gene Amplification
  • Recurrent Squamous Cell Lung Carcinoma
  • Stage IV Squamous Cell Lung Carcinoma AJCC v7

Interventions

DRUG

Docetaxel

Given IV (arm II closed to accrual 12/18/2015)

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Palbociclib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Vassiliki Papadimitrakopoulou · SWOG Cancer Research Network

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-06-30
Completion
2019-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02785939 on ClinicalTrials.gov