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NCT04013542 · ClinicalTrials.gov registry record · Phase 1

Ipilimumab and Nivolumab in Combination With Radiation Therapy in Treating Patients With Stage 2-3 Non-small Lung Cancer

A Phase 1 study of Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.

Active
Registry status
Phase 1
Development phase
21
Enrollment target
1
Study location

NCT04013542 is a Phase 1 study of Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 21 participants, below the 160-participant average among 47 other Lung Non-Small Cell Carcinoma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04013542, a Phase 1 study of Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
21 participants
Enrollment target
1
Study location

Study Summary

This phase I trial studies the side effects of ipilimumab and nivolumab in combination with radiation therapy, and to see how well they work in treating patients with stage II-III non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Ipilimumab and nivolumab may also help radiation therapy work better by making tumor cells more sensitive to the radiation therapy. Giving ipilimumab and nivolumab in combination with radiation therapy may work better in treating patients with stage II-III non-small cell lung cancer compared to standard chemotherapy in combination with radiation therapy.

Conditions Studied

Lung Non-Small Cell Carcinoma Stage III Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage II Lung Cancer AJCC v8 Stage IIA Lung Cancer AJCC v8 Stage IIB Lung Cancer AJCC v8 EGFR Gene Mutation Locally Advanced Lung Non-Small Cell Carcinoma ALK Gene Rearrangement

Interventions

  • RADIATION Radiation Therapy
  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Ipilimumab

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2019-09-13
Est. Completion 2027-12-31
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04013542

The ClinicalTrials.gov registry entry for NCT04013542 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 160-participant average among 47 other Lung Non-Small Cell Carcinoma trials with a reported enrollment target (87% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Lung Non-Small Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Radiation Therapy is the first listed.

NCT04013542 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04013542 about?

NCT04013542 is a clinical study titled "Ipilimumab and Nivolumab in Combination With Radiation Therapy in Treating Patients With Stage 2-3 Non-small Lung Cancer". This phase I trial studies the side effects of ipilimumab and nivolumab in combination with radiation therapy, and to see how well they work in treating patients with stage II-III non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the bod...

What is the current status of trial NCT04013542?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2019-09-13. Estimated completion is 2027-12-31.

What conditions does trial NCT04013542 study?

This clinical trial studies the following conditions: Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8.

What interventions are being tested in trial NCT04013542?

The interventions under investigation include: Radiation Therapy (RADIATION), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04013542?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04013542 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.