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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05769504
Other study ID # 86382894
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2024
Est. completion date April 2026

Study information

Verified date March 2023
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone 415-900-4227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Clinical study participation percentages haven't always been fully representative of a given demographic. The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through. The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future small cell lung cancer patients during clinical trials.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date April 2026
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged = 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed. - Participant has a diagnosis of small cell lung cancer. - Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. Exclusion Criteria: - Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent. - Pregnant or lactating woman - Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Power Life Sciences Inc.

References & Publications (3)

Seto Z, Takata N, Murayama N, Tokui K, Okazawa S, Kambara K, Imanishi S, Miwa T, Hayashi R, Matsui S, Inomata M. Irinotecan monotherapy as third- or further-line treatment for patients with small cell lung cancer. Tumori. 2021 Dec;107(6):536-541. doi: 10.1177/0300891620974762. Epub 2020 Nov 25. — View Citation

van Meerbeeck JP, Fennell DA, De Ruysscher DK. Small-cell lung cancer. Lancet. 2011 Nov 12;378(9804):1741-55. doi: 10.1016/S0140-6736(11)60165-7. Epub 2011 May 10. — View Citation

Xing H, Zhang J, Ge F, Yu X, Bian H, Zhang F, Fang J. [Analysis of the Efficacy of Irinotecan in the Second-line Treatment of Refractory and Relapsed Small Cell Lung Cancer]. Zhongguo Fei Ai Za Zhi. 2021 Mar 20;24(3):167-172. doi: 10.3779/j.issn.1009-3419.2021.103.04. Chinese. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of patients who decide to enroll in a small cell lung cancer clinical study. 3 months
Primary Number of small cell lung cancer patients who remain in clinical trial until completion. 12 months
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