Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04367311 · ClinicalTrials.gov registry record · Phase 2

Adjuvant Treatment With Cisplatin-based Chemotherapy Plus Concomitant Atezolizumab in Patients With Stage I (Tumors ≥ 4cm), IIA, IIB, and Select Stage III [Any T1-3 N1-2 and T4N0-2] Resected Non-small Cell Lung Cancer (NSCLC) and the Clearance of Circulating Tumor DNA (ctDNA)

A Phase 2 study of Lung Cancer and NSCLC, sponsored by Nasser Hanna.

Active
Registry status
Phase 2
Development phase
100
Enrollment target
9
Study locations

NCT04367311 is a Phase 2 study of Lung Cancer and NSCLC that is active but no longer recruiting, run by Nasser Hanna. The registered enrollment target is 100 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (89% lower). The trial reports 9 study locations across 8 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04367311, a Phase 2 study of Lung Cancer and NSCLC, is active but no longer recruiting, sponsored by Nasser Hanna.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
100 participants
Enrollment target
9
Study locations

Study Summary

The vast majority of patients with stage I (tumors ≥ 4cm), IIA, IIB (and select stage III) NSCLC are managed with upfront surgery, followed by adjuvant chemotherapy. However, relapse rates remain high and are primarily due to distant, metastatic disease. Previous meta-analysis evaluating the use of neo-adjuvant chemotherapy and adjuvant chemotherapy demonstrate a similar impact on improved disease free survival (DFS) and overall survival (OS). The role of checkpoint inhibitors has been proven to be effective in the treatment of patients with advanced NSCLC, regardless of histology and PD-L1 expression. Results from trials evaluating the use of checkpoint inhibitors alone or in combination with chemotherapy in the neoadjuvant setting for early stage disease are promising. However, there are no trials evaluating the role of concomitant chemotherapy and checkpoint inhibitors in the adjuvant setting. In addition, emerging data supports the use of ctDNA as a promising biomarker for early detection of minimal residual disease and have indicated that the presence of detectable ctDNA after surgery for localized lung cancer is correlated with a 90-100% chance for disease recurrence. Therefore, we propose this current study assessing concomitant chemotherapy plus Atezolizumab in the adjuvant setting for patients with stage I (tumors ≥ 4cm), IIA, IIB (and select stage III) NSCLC who have detectable ctDNA after surgery. The clearance of ctDNA will serve as a surrogate for long term DFS and OS in this patient population.

Conditions Studied

Lung Cancer NSCLC

Interventions

  • DRUG Docetaxel
  • DRUG Atezolizumab
  • DRUG Cisplatin
  • DRUG Pemetrexed

Study Locations (9)

New Jersey

  • Summit Health - Berkeley Heights
  • Rutgers Cancer Institute of New Jersey - New Brunswick

Illinois

  • Northwestern University Feinberg School of Medicine - Chicago

Indiana

  • Indiana University Melvin and Bren Simon Cancer Center - Indianapolis

New York

  • New York University Clinical Cancer Center - New York

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Pennsylvania

  • Penn State Cancer Institute - Hershey

Virginia

  • University of Virginia Health System - Charlottesville

Wisconsin

  • University of Wisconsin - Madison

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2020-05-22
Est. Completion 2026-03
Phase Phase 2

Sponsor

Nasser Hanna

4 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04367311

The ClinicalTrials.gov registry entry for NCT04367311 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (89% lower). The listed sponsor is Nasser Hanna, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.

NCT04367311 reports 9 study locations spanning 8 distinct geographic areas - top geographies include New Jersey, Illinois, Indiana.

Frequently Asked Questions

What is clinical trial NCT04367311 about?

NCT04367311 is a clinical study titled "Adjuvant Treatment With Cisplatin-based Chemotherapy Plus Concomitant Atezolizumab in Patients With Stage I (Tumors ≥ 4cm), IIA, IIB, and Select Stage III [Any T1-3 N1-2 and T4N0-2] Resected Non-small Cell Lung Cancer (NSCLC) and the Clearance of Circulating Tumor DNA (ctDNA)". The vast majority of patients with stage I (tumors ≥ 4cm), IIA, IIB (and select stage III) NSCLC are managed with upfront surgery, followed by adjuvant chemotherapy. However, relapse rates remain high and are primarily due to distant, metastatic disease. Previous meta-analysis evaluating the use of ...

What is the current status of trial NCT04367311?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2020-05-22. Estimated completion is 2026-03.

What conditions does trial NCT04367311 study?

This clinical trial studies the following conditions: Lung Cancer, NSCLC.

What interventions are being tested in trial NCT04367311?

The interventions under investigation include: Docetaxel (DRUG), Atezolizumab (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG).

Who is sponsoring clinical trial NCT04367311?

This trial is sponsored by Nasser Hanna, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04367311 being conducted?

This trial has 9 study locations across Illinois, Indiana, New Jersey, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Lung Cancer

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.

Explore more on PlainTrial

Lung Cancer

All registered trials for this condition

NSCLC

All registered trials for this condition

Illinois

All trials with a study site in Illinois

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
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.