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ACTIVE NOT RECRUITING Phase 1

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

NCT04013542 · View on ClinicalTrials.gov ↗

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.

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

2,992 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,992 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04013542 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04013542?

The interventions under investigation include: Radiation Therapy (RADIATION), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04013542?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,992 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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