Stage IV Lung Cancer AJCC v8 Clinical Trial
Official title:
A Phase 1b Study of Ensartinib in Combination With Platinum-Based Chemotherapy and Bevacizumab in ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
This phase Ib trial finds the best dose and side effects of ensartinib and its effects when given with carboplatin, pemetrexed and bevacizumab for in treating patients with ALK-positive non-small cell lung cancer that is stage IIIC or IV, or has come back (recurrent). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and pemetrexed, 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. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving ensartinib, carboplatin, pemetrexed and bevacizumab may help to control the disease.
PRIMARY OBJECTIVES: I. To determine the safety of ensartinib in combination with carboplatin, pemetrexed and bevacizumab in patients with ALK-rearranged advanced non-small cell lung cancer (NSCLC). II. Determine the recommended phase 2 dose (RP2D) of ensartinib in combination with carboplatin, pemetrexed and bevacizumab. SECONDARY OBJECTIVES: I. To determine an objective response rate (ORR) in patients with ALK-rearranged advanced NSCLC treated with ensartinib in combination with carboplatin, pemetrexed and bevacizumab using modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1). II. To determine progression-free survival (PFS). III. To determine overall survival. EXPLORATORY OBJECTIVE: I. To determine biomarkers associated with response and resistance to the study combination. OUTLINE: This is a dose de-escalation study of ensartinib and fixed-dose carboplatin, pemetrexed, and bevacizumab followed by a dose-expansion study. INDUCTION THERAPY: Patients receive ensartinib orally (PO) once daily (QD) on days 1-21, carboplatin intravenously (IV) over 15-60 minutes on day 1, pemetrexed IV over 10 minutes on day 1 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive ensartinib PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days. ;
| 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 | |
| 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 |