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: Active Phase 2 study of Lung Cancer and NSCLC, sponsored by Nasser Hanna.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To estimate the percentage of patients with undetectable circulating tumor DNA (ctDNA) after 4 cycles of adjuvant chemotherapy + Atezolizumab plus up to 13 additional cycles of Atezolizumab in patients with stage I (tumors ≥ 4cm), IIA, IIB, and select stage III \[any T1-3 N1-2 and T4N0-2\] NSCLC who have detectable ctDNA after surgery, but prior to adjuvant therapy. At each time point, ctDNA detection status (detectable or not detectable) will be determined by CAPP-seq using the Monte Carlo-bas
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-05-22 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
What the registry record for NCT04367311 still lists
NCT04367311 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (89% lower).
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 lists 9 locations in 8 states (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.
Where NCT04367311's enrollment target sits among peer trials
100 186th of 409 higher than 212 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer 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
-
Study of Novel Treatment Combinations in Patients With Lung Cancer
RECRUITING · Phase 2
-
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
RECRUITING · Phase 2
-
ATATcH Alternating Treatment Plans for Advanced Cancer
RECRUITING · Phase 2
-
A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation
RECRUITING · Phase 2
-
Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial
RECRUITING · Phase 2
-
Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI