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NCT03373760 · ClinicalTrials.gov registry record · Phase 2

Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer

A Phase 2 study of Recurrent Squamous Cell Lung Carcinoma and Stage IV Squamous Cell Lung Carcinoma AJCC v7, sponsored by SWOG Cancer Research Network.

Completed
Registry status
Phase 2
Development phase
67
Enrollment target
20
Study locations

NCT03373760: Completed Phase 2 study of Recurrent Squamous Cell Lung Carcinoma and Stage IV Squamous Cell Lung Carcinoma AJCC v7, sponsored by SWOG Cancer Research Network.

NCT03373760 is a Phase 2 study of Recurrent Squamous Cell Lung Carcinoma and Stage IV Squamous Cell Lung Carcinoma AJCC v7 that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 67 participants, below the 140-participant average among 3 other Recurrent Squamous Cell Lung Carcinoma trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03373760, a Phase 2 study of Recurrent Squamous Cell Lung Carcinoma and Stage IV Squamous Cell Lung Carcinoma AJCC v7, has completed, sponsored by SWOG Cancer Research Network.

COMPLETED
Registry status
Phase 2
Development phase
67 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.

Primary Outcome

Percentage of participants with confirmed or unconfirmed, complete or partial response to treatment with MEDI4736 (durvalumab) plus tremelimumab per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Complete Response (CR): Complete disappearance of all target and non-target lesions. No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to \< 1.0 cm. All disease must be assessed using the same technique as

Interventions

  • BIOLOGICAL Durvalumab
  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Tremelimumab

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine - Anchorage
  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Oncology and Hematology LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage
  • Fairbanks Memorial Hospital - Fairbanks

California

  • Kaiser Permanente-Anaheim - Anaheim
  • Kaiser Permanente-Deer Valley Medical Center - Antioch
  • Sutter Auburn Faith Hospital - Auburn
  • Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
  • AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
  • Kaiser Permanente-Baldwin Park - Baldwin Park
  • Kaiser Permanente-Bellflower - Bellflower

Arizona

  • University of Arizona Cancer Center-North Campus - Tucson
  • The University of Arizona Medical Center-University Campus - Tucson

Arkansas

  • Mercy Cancer Center-Hot Springs - Hot Springs
  • Fowler Family Center for Cancer Care - Jonesboro

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2017-11-30
Est. Completion 2022-03-29
Phase Phase 2
SWOG Cancer Research Network

270 total trials

What the finished NCT03373760 record still lists

NCT03373760 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 140-participant average among 3 other Recurrent Squamous Cell Lung Carcinoma trials with a reported enrollment target (52% lower).

The record links to 2 conditions, with Recurrent Squamous Cell Lung Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Durvalumab is the first listed.

NCT03373760 names 20 study sites across 5 states, led by Alaska, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT03373760 about?

NCT03373760 is a clinical study titled "Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer". This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.

What is the current status of trial NCT03373760?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2017-11-30. Estimated completion is 2022-03-29.

What conditions does trial NCT03373760 study?

This clinical trial studies the following conditions: Recurrent Squamous Cell Lung Carcinoma, Stage IV Squamous Cell Lung Carcinoma AJCC v7.

What interventions are being tested in trial NCT03373760?

The interventions under investigation include: Durvalumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Tremelimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03373760?

This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03373760 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT03373760, the US trial registry maintained by the National Library of Medicine. NCT03373760 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.