Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03410043 · ClinicalTrials.gov registry record · Phase 2
Osimertinib, Surgery, and Radiation Therapy in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer With EGFR Mutations, NORTHSTAR Study
A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 173
- Enrollment target
- 4
- Study locations
NCT03410043: Active Phase 2 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT03410043 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 173 participants, above the 96-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (80% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03410043, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 173 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase II trial studies how well osimertinib, surgery, and radiation therapy work in treating patients with stage IIIB or IV non-small cell lung cancer with EGFR mutations. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving osimertinib, surgery, and radiation therapy may work better at treating non-small cell lung cancer with EGFR mutations.
Primary Outcome
Will be estimated using Kaplan-Meier method. The stratified log-rank test will be performed to test the difference in time-to-event distributions between treatment groups. Stratified Cox proportional hazards model will be utilized to include multiple covariates in the time-to-event analysis and to estimate hazard ratios.
Conditions Studied
Interventions
- DRUG Osimertinib
- RADIATION Radiation Therapy
- PROCEDURE Therapeutic Conventional Surgery
Study Locations (4)
California
- UCSF Medical Center-Mount Zion - San Francisco
Colorado
- University of Colorado - Denver
New York
- Memorial Sloan Kettering Cancer Center - New York
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2018-01-17 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 2 |
What the registry record for NCT03410043 still lists
NCT03410043 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, above the 96-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (80% higher).
The record links to 6 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Osimertinib is the first listed.
NCT03410043 reports a single indexed study location in California, Colorado, New York.
Frequently Asked Questions
What is clinical trial NCT03410043 about?
NCT03410043 is a clinical study titled "Osimertinib, Surgery, and Radiation Therapy in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer With EGFR Mutations, NORTHSTAR Study". This phase II trial studies how well osimertinib, surgery, and radiation therapy work in treating patients with stage IIIB or IV non-small cell lung cancer with EGFR mutations. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy us...
What is the current status of trial NCT03410043?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 173 participants. The study started on 2018-01-17. Estimated completion is 2026-04-01.
What conditions does trial NCT03410043 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Lung Non-Small Cell Carcinoma, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8.
What interventions are being tested in trial NCT03410043?
The interventions under investigation include: Osimertinib (DRUG), Radiation Therapy (RADIATION), Therapeutic Conventional Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT03410043?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03410043 being conducted?
This trial has 4 study locations across California, Colorado, New York, Texas. 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 NCT03410043's enrollment target sits among peer trials
173 12th of 81 higher than 70 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
-
Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)
RECRUITING · Phase 2
-
Defactinib, Avutometinib and Nivolumab for the Treatment of Anti-PD1 Refractory LKB1-Mutant Advanced Non-Small Cell Lung Cancer
RECRUITING · Phase 2
-
Grid Radiation Therapy for the Treatment of Stage IV Non-Small Cell Lung Cancer
RECRUITING · Phase 2
-
Diclofenac for the Treatment of Patients With Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy
RECRUITING · Phase 2
-
GT103 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic STK11 Mutant Non-Small Cell Lung Cancer
RECRUITING · Phase 2
-
Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive Oncogenic Positive Non-Small Cell Lung Carcinoma
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
- NCT05568719 · 173 participants · Phase 3
Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
- NCT07070115 · 173 participants · NA
Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
- NCT07150832 · 173 participants · NA
Efficacy of the I-CARE Digital Health Intervention
- NCT01000259 · 174 participants
Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
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