Clinical Trials Logo

Clinical Trial Summary

Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, ROS1 mutation if available or MET exon 14 skipping mutation if available) will receive a tri-therapy associating avelumab, axitinib and palbociclib.


Clinical Trial Description

During the Phase 1 (approximately 30 patients), the tri-therapy will be tested at different doses following a specific dose-escalation scheme (3 + 3 model) in order to establish the safety and identify the Maximum Tolerated Dose (MTD) and recommended dose for the Phase 2 (RP2D). The phase 2 will confirm the safety and will assess the clinical utility of the tri-therapy approach in the treatment of advanced/metastatic NSCLC (100 patients). The study will also explore the clinical utility of the Simplified Interventional Mapping System (SIMS), a new tool/algorithm enabling matching of NSCLC patients with combination therapy. For this purpose tumor/metastasis and matched normal tissue biopsies will be requested in order to obtain sequencing and expression profiles. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03386929
Study type Interventional
Source Worldwide Innovative Network Association
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date November 29, 2017
Completion date December 29, 2022

See also
  Status Clinical Trial Phase
Completed NCT01523340 - A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response
Recruiting NCT03956641 - Evolution of the Physical Condition in Treated Cancer Patients N/A
Active, not recruiting NCT02035683 - PET/CT Scan as a Tool to Rationalize the Treatment of of Advanced NSCLC Patients Undergoing First Chemotherapy N/A
Completed NCT01848613 - Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC Phase 4
Suspended NCT01320501 - Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer Phase 4
Terminated NCT01471964 - Study to Assess Safety and Tolerability of MLN8237, In Combination With Erlotinib to Treat Non-Small Cell Lung Cancer Phase 1/Phase 2
Recruiting NCT06127940 - K-SAB Trial - Sotorasib Followed by SBRT to 1-3 Lesions in Advanced NSCLC With KRASG12C Mutation Phase 1
Terminated NCT04069936 - Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC Phase 2
Terminated NCT03445000 - ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer Phase 2
Recruiting NCT02922764 - A Study of RGX-104 in Patients With Advanced Lung & Endometrial Cancer Phase 1
Terminated NCT01574300 - Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network
Active, not recruiting NCT04646824 - Almonertinib With Chemotherapy in mEGFR NSCLC Phase 2
Completed NCT01966003 - Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer Phase 3
Recruiting NCT03656094 - Chemotherapy With Pembrolizumab Continuation After Progression to PD-1/L1 Inhibitors Phase 2
Terminated NCT01348126 - Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer Phase 2/Phase 3
Active, not recruiting NCT03469960 - Double Immune Checkpoint Inhibitors in PD-L1-positive Stage IV Non-small Lung CancEr Phase 3
Recruiting NCT05919264 - FOG-001 in Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT04793815 - Lung Cancer Cryo-Activation as a Novel Approach to Augment Immunotherapy Efficacy (CRYOVATE) N/A
Terminated NCT01380795 - Feasibility of the Research for Mutation of K-ras and EGFR in CTCs From Metastatic Non Small Cells Bronchial Carcinomas Early Phase 1
Completed NCT02959619 - Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK Phase 1