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NCT04919382 · ClinicalTrials.gov registry record · Phase 2

Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer

A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, sponsored by Dwight Owen.

Recruiting
Registry status
Phase 2
Development phase
56
Enrollment target
5
Study locations

NCT04919382: Recruiting Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, sponsored by Dwight Owen.

NCT04919382 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8 that is actively recruiting participants, run by Dwight Owen. The registered enrollment target is 56 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (43% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04919382, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, is actively recruiting participants, sponsored by Dwight Owen.

RECRUITING
Registry status
Phase 2
Development phase
56 participants
Enrollment target
5
Study locations

Study Summary

This phase II trial studies the effects of temozolomide and atezolizumab as second or third line treatment for patients with small cell lung cancer that has spread to other places in the body (metastatic) or has come back (recurrent). Chemotherapy drugs, such as temozolomide, 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. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving temozolomide and atezolizumab as second or third line treatment may help prolong survival in patients with small cell lung cancer.

Primary Outcome

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Response will be defined by a confirmed complete response (CR) or confirmed partial response (PR). Response will be defined for patients with measurable disease and who receive at least one dose of combination treatment. ORR rate will be calculated as the proportion of patients with RECIST-based PR or CR divided by the total number of evaluable patients. Exact binomial 90% and 95% confidence intervals for the true PR+CR respo

Conditions Studied

Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Extensive Stage Lung Small Cell Carcinoma Metastatic Lung Small Cell Carcinoma Recurrent Lung Small Cell Carcinoma

Interventions

  • BIOLOGICAL Atezolizumab
  • DRUG Temozolomide

Study Locations (5)

Illinois

  • University of Illinois Cancer Center - Chicago

Indiana

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis

Iowa

  • University of Iowa Hospitals and Clinics - Iowa City

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Wisconsin

  • University of Wisconsin - Madison

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2022-01-26
Est. Completion 2027-12-31
Phase Phase 2
Dwight Owen

6 total trials

What NCT04919382 shows while recruiting

NCT04919382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (43% lower).

The record links to 6 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Atezolizumab is the first listed.

NCT04919382 lists 5 locations in 5 states (Illinois, Indiana, Iowa).

Frequently Asked Questions

What is clinical trial NCT04919382 about?

NCT04919382 is a clinical study titled "Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer". This phase II trial studies the effects of temozolomide and atezolizumab as second or third line treatment for patients with small cell lung cancer that has spread to other places in the body (metastatic) or has come back (recurrent). Chemotherapy drugs, such as temozolomide, work in different ways ...

What is the current status of trial NCT04919382?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2022-01-26. Estimated completion is 2027-12-31.

What conditions does trial NCT04919382 study?

This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Extensive Stage Lung Small Cell Carcinoma, Metastatic Lung Small Cell Carcinoma.

What interventions are being tested in trial NCT04919382?

The interventions under investigation include: Atezolizumab (BIOLOGICAL), Temozolomide (DRUG).

Who is sponsoring clinical trial NCT04919382?

This trial is sponsored by Dwight Owen, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04919382 being conducted?

This trial has 5 study locations across Illinois, Indiana, Iowa, Ohio, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Stage IV Lung Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04919382's enrollment target sits among peer trials

56 31st of 81 higher than 49 of 81 other Stage IV Lung Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04919382

Source: ClinicalTrials.gov NCT04919382, the US trial registry maintained by the National Library of Medicine. NCT04919382 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.