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Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

NCT03137771 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2025-11-25

Study results available
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Summary

This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without local consolidation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, erlotinib hydrochloride, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Local consolidation therapy such as radiation/stereotactic body radiation or surgery may kill cancer cells left after initial treatment. Giving maintenance chemotherapy and local consolidation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

Conditions

  • Recurrent Non-Small Cell Lung Carcinoma
  • Stage IV Non-Small Cell Lung Cancer

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy (3D-CRT)

Undergo 3DCRT

DRUG

Docetaxel

Given IV

DRUG

Gemcitabine

Given IV

RADIATION

Intensity-Modulated Radiation Therapy (IMRT)

Undergo IMRT

DRUG

Pemetrexed Disodium

Given IV

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

Undergo SBRT

DRUG

Erlotinib Hydrochloride

Given PO

DRUG

Pembrolizumab

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    lead OTHER

Principal Investigators

  • Puneeth Iyengar · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-07
Primary Completion
2023-12-20
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Israel
  • Saudi Arabia

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 NCT03137771 on ClinicalTrials.gov