NCT05071703 is a Phase 4 clinical trial of Trilaciclib in Extensive-stage Small-cell Lung Cancer, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd..

Who is sponsoring NCT05071703?

NCT05071703 is sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd..

What drugs are being tested in NCT05071703?

Interventions in NCT05071703: Trilaciclib.

What condition does NCT05071703 study?

NCT05071703 studies Extensive-stage Small-cell Lung Cancer.

Is NCT05071703 still recruiting?

NCT05071703 is currently completed. Last updated 6 October 2023.

Last reviewed 2023-10-06 · How we verify

NCT05071703

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

Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study

Completed Phase 4 Last updated 6 October 2023

What this trial tests

Phase 4 trial testing Trilaciclib in Extensive-stage Small-cell Lung Cancer in 30 participants. Completed in 30 November 2022.

Timeline

11 August 2021

Primary endpoint
10 April 2022

30 November 2022

Quick facts

Lead sponsor	Jiangsu Simcere Pharmaceutical Co., Ltd.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	11 August 2021
Primary completion	10 April 2022
Estimated completion	30 November 2022
Sites	1 location across China

Drugs / interventions tested

Trilaciclib — full drug profile →

Conditions studied

Extensive-stage Small-cell Lung Cancer — all drugs for Extensive-stage Small-cell Lung Cancer →

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 100, any sex, with Extensive-stage Small-cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-arm, real-world study in Chinese patients with extensive stage small cell lung cancer. The purpose of this study was to evaluate Trilaciclib's protection against chemotherapy-induced bone marrow suppression, the safety and the impact on the antitumor effects of the combination with chemotherapy in Chinese patients with ES-SCLC in the real world. Patients with ES-SCLC who already use or plan to use Trilaciclib will be invited to participate in the study. Data were collected from 28 days prior to initial chemotherapy (platinum/etoposide or topotecan systemic chemotherapy) after patients signed informed consent until patients died, dropped out of the study, lost to follow-up, informed withdrawal, or study termination. The end time of the study was defined as withdrawal of information, loss of follow-up or death of all enrolled patients, or 12 months after the last patient was enrolled, whichever happened earlier.

Publications & conference data

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

CDK4/6 inhibitors in lung cancer: current practice and future directions.
Lv S, Yang J, Lin J, Huang X, et al · · 2024 · cited 20× · PMID 38355149 · DOI 10.1183/16000617.0145-2023
Role of HOXA9 in solid tumors: mechanistic insights and therapeutic potential.
Tang L, Peng L, Tan C, Liu H, et al · · 2022 · cited 19× · PMID 36376832 · DOI 10.1186/s12935-022-02767-9
CDK4/6 inhibition confers protection of normal gut epithelia against gemcitabine and the active metabolite of irinotecan.
Blume J, Claus L, Isermann T, Dickmanns A, et al · · 2023 · cited 2× · PMID 37266562 · DOI 10.1080/15384101.2023.2217003

Verify or expand the search:

Other trials of Trilaciclib

Trials testing the same drug.

NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
NCT06714266 — Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell · Phase 2 · not yet recruiting
NCT06698965 — Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Tr · Phase 2 · recruiting
NCT06490081 — Trilaciclib Prevents Myelosuppression With Chemoradiotherapy · Phase 2 · recruiting
NCT06370416 — the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib · Phase 2 · enrolling by invitation

Other recruiting trials for Extensive-stage Small-cell Lung Cancer

Currently open trials in the same condition.

NCT07244016 — Clinical Study on Using TCR to Predict the Effect of Tislelizumab + Chemotherapy in the First-line Treatment of ES-SCLC · recruiting
NCT05588388 — Study of Bevacizumab in Combination With Chemoimmunotherapy and Atezolizumab in Patients With Extensive Stage Small Cell · Phase 2 · recruiting
NCT06536868 — Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC · Phase 2 · recruiting
NCT06217757 — Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC · Phase 1, PHASE2 · recruiting
NCT06008353 — A Real-World Assessment of the Demographic, Clinical Characteristics and Outcomes of a Brazilian Cohort of Previously Un · active not recruiting

Other Jiangsu Simcere Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07345364 — A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics · Phase 1 · not yet recruiting
NCT07357610 — An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healt · Phase 1 · recruiting
NCT07175233 — A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis · Phase 2 · not yet recruiting
NCT06686745 — Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors · Phase 1 · recruiting
NCT06680921 — A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Brea · Phase 3 · recruiting

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 NCT05071703 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Jiangsu Simcere Pharmaceutical Co., Ltd.
Last refreshed: 6 October 2023

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/NCT05071703.

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