NCT04933175

Fluzopalil in Combination With Anlotinib for Extensive Small-cell Lung Cancer Following Failure of First-line Platinum-containing Chemotherapy: a Multicenter, Single-arm Prospective Phase II Clinical Study (STAMP Study)

Status unknown Phase 2 Last updated 17 June 2021

What this trial tests

Phase 2 trial testing Fluzoparil in Extensive Stage Small Cell Lung Cancer in 50 participants. Status unknown.

Timeline

1 June 2021

Primary endpoint
1 June 2022

1 June 2023

Quick facts

Lead sponsor	Liu Zhenhua
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 June 2021
Primary completion	1 June 2022
Estimated completion	1 June 2023
Sites	1 location across China

Drugs / interventions tested

• Fluzoparil — full drug profile →
• Anlotinib — full drug profile →

Conditions studied

• Extensive Stage Small Cell Lung Cancer — all drugs for Extensive Stage Small Cell Lung Cancer →

Sponsor

Liu Zhenhua

Who can join

Adults 18 to 75, any sex, with Extensive Stage 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.

• Objective Overall Response Rate (ORR)
  Time frame: From randomization to 24 month
  ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR to be a res

Sponsor's own description

This is a the researchers launched a multicenter, prospective, single arm phase II clinical study, the group always had at least two cycle line standard platinum-based treatment and curative effect for SD, at least 6 months during or after the treatment of disease progression broad stage small cell lung cancer patients, evaluating the efficacy and safety of fluzopalil combination With anlotinib. Fifty patients are expected to be enrolled in this study.

Publications & conference data

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

1. Targeted Therapies in Small Cell Lung Cancer: From Old Failures to Novel Therapeutic Strategies.
   Cani M, Napoli VM, Garbo E, Ferrari G, et al · · 2023 · cited 11× · PMID 37240229 · DOI 10.3390/ijms24108883
2. Efficacy and safety of fluzoparib combined with anlotinib in extensive stage small cell lung cancer after first-line platinum-based chemotherapy: a multi-center, single-arm prospective phase II clinical study (STAMP study).
   Li D, Huang Z, Zhong J, Lin L, et al · · 2023 · cited 9× · PMID 37580661 · DOI 10.1186/s12885-023-11230-5
3. Small cell lung cancer: emerging subtypes, signaling pathways, and therapeutic vulnerabilities.
   Zhang J, Zeng X, Guo Q, Sheng Z, et al · · 2024 · cited 8× · PMID 39103941 · DOI 10.1186/s40164-024-00548-w
4. Immunotherapy for small cell lung cancer: the current state and future trajectories.
   Qiang M, Liu H, Yang L, Wang H, et al · · 2024 · cited 4× · PMID 39152301 · DOI 10.1007/s12672-024-01119-5
5. Efficacy and safety of poly ADP-ribose polymerase inhibitors (PARPis) in extensive-stage small-cell lung cancer (ES-SCLC) treatment: a systematic review and meta-analysis.
   Cheng CC, Ma LJ, Pang XM, Huang TS, et al · · 2025 · cited 1× · PMID 40950854 · DOI 10.21037/jtd-2025-1306