Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antibodies

Immunoglobulins

All participants included in the study will receive a starting dose of 6 mg/kg of DS-1062a every 3 weeks until progression or until unacceptable toxicity

First infusion for 90 minutes and then infusion duration can be decreased to 30 minutes if participant didn't experience infusion related reactions (IRR)

DS-1062a

Babara Pistili, Dr

Fernanda Fernanda, Dr

Barbara Pistilli, Dr

Ghada Nachabeh, PM

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.

One group of 100 participants receiving DS-102a

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

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

ORR is defined as the proportion of participants who achieved a confirmed complete response (CR) or partial response (PR) observed on treatment and assessed by investigators

Defined as the time from the first documented CR or PR until the date of disease progression, or until the date of death

Defined as the time date of the first dose until progression or death from any cause, whichever occurs first

Defined as the presence of at least a PR or CR, or a stable disease (SD) for more than six months under treatment

All adverse events (AEs), treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)

Treatment discontinuation, interruptions and dose reductions

Daiichi Sankyo

Gustave Roussy, Cancer Campus, Grand Paris

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Glioma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Gastrointestinal Agents

Trametinib

Dabrafenib

Lactitol

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients in this study may receive:

- monotherapy of dabrafenib

Patients in this study may receive:

- monotherapy of trametinib

Patients in this study may receive:

- the combination of dabrafenib and trametinib

dabrafenib is available in capsules (50mg and 75mg) taken twice a day

dabrafenib

trametinib is available in tablets (0.5mg, 2mg dose)

trametinib

Novartis Pharmaceuticals

Angela Neuckranz

Michael Gordon

Michelle Capozzoli

Robert Kreitman

This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

Dabrafenib and/or Trametinib Rollover Study

Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study

Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.

To evaluate clinical benefit as assessed by the Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Datopotamab (DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer	NCT04940325	Metastatic Lung...	DS-1062a	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
Dabrafenib and/or Trametinib Rollover Study	NCT03340506	Melanoma Non Small Cell ... Solid Tumor Rare Cancers High Grade Glio...	dabrafenib trametinib	18 Years - 100 Years	Novartis

Spots Global Cancer Trial Database for nslc

Every month we try and update this database with for nslc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nslc

Every month we try and update this database with for nslc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nslc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.