Stage IV Lung Cancer AJCC v8 Clinical Trial
Official title:
A Phase Ib/II, Open-Label, Multi-Center Study of EMB-01 in Combination With Osimertinib in Patients With Advanced/Metastatic EGFR Mutant Lung Cancer
This phase Ib/II trial studies the side effects and best dose of EMB-01 when given together with osimertinib in patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (advanced or metastatic) and has progressed on standard treatment. EMB-01 and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth in this type of cancer. EMB-01 in combination with osimertinib may work better in treating patients with EGFR-mutant advanced non-small cell lung cancer.
PRIMARY OBJECTIVES: I. To evaluate the maximum tolerated dose (MTD) and to establish the recommended phase II dose (RP2D) of EMB-01 given in combination with osimertinib in patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). (Phase Ib) II. To preliminarily assess efficacy and further evaluate the safety and tolerability of EMB-01 plus osimertinib at the RP2D in advanced EGFR-mutant NSCLC patients who progressed on prior EGFR tyrosine kinase inhibitor (TKI) treatment. The primary endpoint is objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (Phase II) SECONDARY OBJECTIVES: I. To assess the pharmacokinetics (PK) of EMB-01 and osimertinib. II. To assess the immunogenicity of EMB-01 and osimertinib. III. To evaluate preliminary antitumor activity of EMB-01 and osimertinib. (Phase I) IV. To continue to evaluate the antitumor activity of EMB-01 and osimertinib such as progression free survival, best overall response, duration of response, and clinical benefit rate. (Phase II) EXPLORATORY OBJECTIVES: I. To explore the relationships between pharmacokinetics, biomarkers, adverse event profiles, and anticancer activity of EMB-01 combined with osimertinib. OUTLINE: This is a phase Ib, dose-escalation study of EMB-01 and osimertinib followed by a phase II study. Patients receive EMB-01 intravenously (IV) weekly. Patients also receive osimertinib orally (PO) once daily (QD) on days 1-28. Treatment cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. After the completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04267913 -
Testing of TAK228 (MLN0128, Sapanisertib) Plus Docetaxel to the Usual Standard of Care for Advanced Squamous Cell Lung Cancer (A Lung-MAP Treatment Trial)
|
Phase 2 | |
| Recruiting |
NCT04151940 -
PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer
|
N/A | |
| Terminated |
NCT03707925 -
Bronchoscopic Laser Ablation of Peripheral Lung Tumors
|
N/A | |
| Active, not recruiting |
NCT04081688 -
Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC
|
Phase 1 | |
| Recruiting |
NCT04929041 -
Testing the Addition of Radiation Therapy to Immunotherapy for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04250545 -
Testing of the Anti Cancer Drugs CB-839 HCl (Telaglenastat) and MLN0128 (Sapanisertib) in Advanced Stage Non-small Cell Lung Cancer
|
Phase 1 | |
| Terminated |
NCT04396535 -
Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT04514497 -
Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer
|
Phase 1 | |
| Withdrawn |
NCT05161533 -
Hypofractionated Radiation Therapy After Durvalumab and Chemotherapy for the Treatment of Stage IV Extensive Stage Small Cell Lung Cancer, CASPIAN-RT Trial
|
Phase 2 | |
| Recruiting |
NCT04919369 -
All-Trans Retinoic Acid (ATRA) and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 1 | |
| Terminated |
NCT03662074 -
Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer
|
Phase 2 | |
| Recruiting |
NCT04073745 -
Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer
|
Phase 1 | |
| Withdrawn |
NCT04186988 -
[18F]-AraG for the Detection of T-Cell Activation in Advanced Non-small Cell Lung Cancer Patients Undergoing PD-1/PD-L1-Directed Therapy
|
Early Phase 1 | |
| Active, not recruiting |
NCT03600701 -
Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03637816 -
Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
| Recruiting |
NCT05234307 -
PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT06122064 -
A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer
|
N/A | |
| Active, not recruiting |
NCT04533451 -
Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03776253 -
Conquer Fear SUPPORT Intervention in Supporting Patients With Stage III-IV Lung or Gynecologic Cancer
|
N/A |