Clinical Trials Logo
  1. Home
  2. Metastatic Lung Cancer
  3. NCT04940325

Datopotamab (DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer — ICARUS-LUNG01  

Metastatic Lung Cancer Clinical Trial

Official title:
Phase 2, Open Label Study of DS-1062a, an Anti-TROP-2-Antibody-Drug Conjugate (ADC), in Patients With Advanced and/or Unresectable Non-Small Cell Lung Cancer (NSCLC), With Biomarker Analysis to Characterize Response to Therapy

Clinical Trial Summary

This study aims to evaluate the efficacy and safety of DS-1062a in participants with metastatic, unresectable NSCLC having progressed on one, but not more than three previous standard therapies. Moreover, the immune effects, the predictors of resistance and response to treatment, the effect of the chemotherapy on deoxyribonucleic acid (DNA) replication will be assessed and will help identify the subgroups that will mostly benefit from the treatment. The pharmacokinetics of the product and the anti-drug antibody (ADA) will be also evaluated. A total of 100 participants are planned to be included in the study. Participants will receive, every three weeks, a dose of DS-1062a equivalent to 6 mg/kg of body weight until progression or until unacceptable toxicity. Tumor evaluation will be performed every six weeks by the mean of a computed tomography for the thorax, abdomen and pelvis (TAP CT-scan) or a magnetic resonance imaging (MRI). Brain and/or bone CT scans will be also performed throughout the study for participants with brain and/or bone metastasis. The safety of the product will be assessed at each cycle, through complete clinical exams, biological tests, electrocardiograms (ECGs), cardiac echographies (ECHOs) and through the collection of ongoing toxicities or adverse events.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04940325
Study type Interventional
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Babara Pistili, Dr
Phone +33 (0)1 42 11 42 11
Email barbara.pistilli@gustaveroussy.fr
Status Recruiting
Phase Phase 2
Start date May 12, 2021
Completion date November 12, 2025
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Recruiting NCT05846594 - A Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer Phase 4
Not yet recruiting NCT03514329 - Vapor Ablation for Localized Cancer Lesions N/A
Recruiting NCT05502913 - Fecal Microbiota Transplantation With Immune Checkpoint Inhibitors in Lung Cancer Phase 2
Recruiting NCT06060613 - Safety and Efficacy of OBX-115 in Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT00986661 - A Study to Assess PV-10 Chemoablation of Cancer of the Liver Phase 1
Recruiting NCT05609578 - Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation Phase 2
Completed NCT01543672 - Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously Phase 1/Phase 2
Completed NCT03198468 - Vapor Ablation for Localized Cancer Lesions of the Lung (VAPORIZE) N/A
Recruiting NCT06180460 - CALM: Managing Distress in Malignant Brain Cancer N/A
Completed NCT04804137 - Immune Response Under Immunotherapy in Metastatic NSCLC: Sputum, Blood Samples and Microbioata Study
Recruiting NCT06343402 - Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer Phase 1
Active, not recruiting NCT05241873 - (Concerto) Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations Phase 1/Phase 2
Recruiting NCT05256290 - Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations Phase 1/Phase 2
Completed NCT05908799 - Emulation of the KEYNOTE-189 Trial Using Electronic Health Records
Active, not recruiting NCT03867175 - Immunotherapy With or Without SBRT in Patients With Stage IV Non-small Cell Lung Cancer Phase 3
Recruiting NCT04708483 - DCE-CT of Thoracic Tumors as an Early Biomarker for Treatment Monitoring in Comparison With Morphologic Criteria N/A
Completed NCT01307501 - Safety and Efficacy of Cryoablation for Metastatic Lung Tumors N/A
Recruiting NCT03143322 - Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 5 Bone-only Metastases N/A
Recruiting NCT05143970 - A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors Phase 1