Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Small Cell Lung Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Participants with advanced/metastatic lung cancer (advanced NSCLC (IIIB/IV) and extensive disease SCLC) in China

Bristol-Myers Squibb

The purpose of the study is to document real-world pattern of care, outcomes and health resource use for participants diagnosed with and receiving treatment for advanced Non-small cell lung cancer (NSCLC) and extensive disease Small cell lung cancer (SCLC) in China.

Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced Lung Cancer

Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced/Metastatic Lung Cancer: a Retrospective Observational Study

Proportion of patients receiving first-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

Proportion of patients receiving second-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

Proportion of patients receiving third-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

Proportion of patients receiving fourth-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

All chemotherapy, radiation and/or biologic drugs given to a patient during the first 28 days after initiation of treatment

All chemotherapy, radiation and/or biologic drugs given to a patient following first-line regimen

Calculated by the difference between the treatment start date of the first observed drug in the regimen and the last observed date of the regimen

Distribution of other cancer-directed therapies including surgery and radiation as well as supportive care

Antineoplastic Agents

All Drugs and Chemicals

Topotecan

Poly(ADP-ribose) Polymerase Inhibitors

Veliparib

Topoisomerase I Inhibitors

Enzyme Inhibitors

Topotecan and Veliparib in increasing doses

Topotecan at increasing doses (1x or 2x per day) will be administered in each cycle.

veliparib

Topotecan at dose 1.25 mg/m2 will be administered in each cycle.

Berta Moritz, PhD

Joachim von Pawel, MD

Phase I/II Study in Patients With Small Cell Lung Cancer (SCLC) of Veliparib in Combination With Topotecan

For this study sensitive or refractory SCLC patients (refractory to prior chemotherapy defined as having experienced no response or a relapse within 90 days after the end of chemotherapy) will be eligible. In total, around 130 patients will be enrolled, around 30 evaluable patients in phase I and 100 patients in phase II.

The study will consist of two parts:

A preceding Phase I part will be performed to identify the Recommended Dose of veliparib to be administered in the Phase II part in combination with topotecan at the dose regimen of 1.25 mg/m2 (on days 1-5 of a 3 week cycle \[d1-5q21d\]). Each patient will be subjected to an initial cycle of topotecan monotherapy (1.25 mg/m2 on day 1-5 of a 3 week cycle); this run-in cycle shall prove topotecan tolerance of the candidates. Only patients who do not reveal any DLTs receive further treatment with combination therapy. In a dose-escalating 3+3 design the RD of veliparib for the subsequent Phase II part of the study will be defined during a maximum of 5 cycles combination therapy.

The Phase II part will follow upon completion of Phase I.

Study in Patients With SCLC of Veliparib in Combination With Topotecan

adverse events related to study drug(s) qualifying as Dose-Limiting Toxicities (DLT)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced Lung Cancer	NCT03505515	Lung Cancer Non-small Cell ... Small Cell Lung...		18 Years -	Bristol-Myers Squibb
Study in Patients With SCLC of Veliparib in Combination With Topotecan	NCT03227016	Small Cell Lung...	veliparib Topotecan	18 Years - 85 Years	Central European Society for Anticancer Drug Research
Study in Patients With SCLC of Veliparib in Combination With Topotecan	NCT03227016	Small Cell Lung...	veliparib Topotecan	18 Years - 85 Years	Central European Society for Anticancer Drug Research

Spots Global Cancer Trial Database for small cell lung cancer sclc