NCT01497873 is a Phase 2 clinical trial of Topotecan in Small Cell Lung Cancer, sponsored by Chong Kun Dang Pharmaceutical.

Who is sponsoring NCT01497873?

NCT01497873 is sponsored by Chong Kun Dang Pharmaceutical.

What drugs are being tested in NCT01497873?

Interventions in NCT01497873: Topotecan, Belotecan.

What condition does NCT01497873 study?

NCT01497873 studies Small Cell Lung Cancer.

Is NCT01497873 still recruiting?

NCT01497873 is currently completed. Last updated 25 December 2018.

Last reviewed 2018-12-25 · How we verify

NCT01497873

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase IIb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell Inj.) or Topotecan in Patients With Relapsed Small Cell Lung Cancer

Completed Phase 2 Last updated 25 December 2018

What this trial tests

Phase 2 trial testing Topotecan in Small Cell Lung Cancer in 164 participants. Completed in 1 March 2018.

Timeline

1 September 2010

Primary endpoint
1 December 2017

1 March 2018

Quick facts

Lead sponsor	Chong Kun Dang Pharmaceutical
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	164
Start date	1 September 2010
Primary completion	1 December 2017
Estimated completion	1 March 2018
Sites	14 locations across South Korea

Drugs / interventions tested

Topotecan (topotecan) — full drug profile →
Belotecan (BELOTECAN) — full drug profile →

Conditions studied

Small Cell Lung Cancer — all drugs for Small Cell Lung Cancer →

Sponsor

Chong Kun Dang Pharmaceutical — full company profile →

Who can join

18 and older, any sex, with Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Objectives Response Rate(ORR, %)
Time frame: Up to 18weeks
The response rate was defined as the test subject who had a complete response (CR) or a partial response (PR) as determined by the 'tumor response evaluation' criteria specified in the research protocol

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

DNA topoisomerases as molecular targets for anticancer drugs.
Buzun K, Bielawska A, Bielawski K, Gornowicz A. · · 2020 · cited 86× · PMID 32975138 · DOI 10.1080/14756366.2020.1821676
Phytochemical-Based Nanomedicine for Advanced Cancer Theranostics: Perspectives on Clinical Trials to Clinical Use.
Dhupal M, Chowdhury D. · · 2020 · cited 48× · PMID 33244231 · DOI 10.2147/ijn.s259628
Recent updates on nano-phyto-formulations based therapeutic intervention for cancer treatment.
Wahi A, Bishnoi M, Raina N, Singh MA, et al · · 2023 · cited 20× · PMID 38188681 · DOI 10.32604/or.2023.042228
A randomised phase 2b study comparing the efficacy and safety of belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer.
Kang JH, Lee KH, Kim DW, Kim SW, et al · · 2021 · cited 18× · PMID 33191408 · DOI 10.1038/s41416-020-01055-5
Recent Advances in the Clinical Translation of Small-Cell Lung Cancer Therapeutics.
Das S, Samaddar S. · · 2025 · cited 16× · PMID 39858036 · DOI 10.3390/cancers17020255
Evaluation of progression-free survival as a surrogate endpoint for overall survival in small cell lung cancer: a systematic review.
Lin G, Ge F, Yang C, Huang Y. · · 2025 · PMID 41158356 · DOI 10.21037/jtd-2025-469

Verify or expand the search:

Other trials of Topotecan

Trials testing the same drug.

NCT07437963 — Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatmen · Phase 1, PHASE2 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
NCT07321912 — Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma · Phase 2 · not yet recruiting
NCT06425419 — The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy · Phase 1 · not yet recruiting

Other recruiting trials for Small Cell Lung Cancer

Currently open trials in the same condition.

NCT07476287 — Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult · Phase 2 · recruiting
NCT07296809 — SKB500 Combinations in Patients With Small Cell Lung Cancer · Phase 2 · recruiting
NCT07155200 — Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial) · Phase 1, PHASE2 · recruiting
NCT06922539 — ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer · Phase 1 · recruiting
NCT07373964 — A Prospective, Single-Arm, Single-Center Phase II Study Evaluating the Efficacy and Safety of Chidamide Combined With PD · Phase 2 · recruiting

Other Chong Kun Dang Pharmaceutical trials

Trials by the same sponsor.

NCT07404735 — A Clinical Trial to Compare and Evaluate Evaluate the Pharmacokinetics and Safety of CKD-846 · Phase 1 · not yet recruiting
NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E · Phase 1 · recruiting
NCT07258745 — Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-appro · Phase 1 · recruiting
NCT07304726 — Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.25/12.5/1000mg in Healthy Volunteers · Phase 1 · completed
NCT07304700 — Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.5/10/1000mg in Healthy Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01497873 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Chong Kun Dang Pharmaceutical
Last refreshed: 25 December 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01497873.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing