NCT03983759

Study of Sintlimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer

Status unknown Phase 2 Last updated 11 June 2020

What this trial tests

Phase 2 trial testing sintilimab maintenance in Small Cell Lung Cancer in 40 participants. Status unknown.

Timeline

20 June 2019

Primary endpoint
31 May 2021

31 May 2021

Quick facts

Lead sponsor	Henan Cancer Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	20 June 2019
Primary completion	31 May 2021
Estimated completion	31 May 2021
Sites	1 location across China

Drugs / interventions tested

• sintilimab maintenance — full drug profile →

Conditions studied

• Small Cell Lung Cancer — all drugs for Small Cell Lung Cancer →
• Extensive Disease — all drugs for Extensive Disease →
• Adoptive Cellular Immunotherapy — all drugs for Adoptive Cellular Immunotherapy →
• Chemotherapy — all drugs for Chemotherapy →

Sponsor

Henan Cancer Hospital

Who can join

Adults 18 to 70, any sex, with Small Cell Lung Cancer or Extensive Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Small cell lung cancer is a highly aggressive malignancy. Currently, there is no effective regimen for patients after the progression offirst-line chemotherapy. The prognosis of patients with extensive disease is very poor, and the improved therapeutic efficacy is urgently needed. Most patients with small cell lung cancer have a long history of smoking, and the tumor mutation burden is relatively high, which provides potential for immunological checkpoint inhibitors represented by PD-1 antibodies. A number of studies have shown that chemotherapy combined with adoptive cellular immunotherapy could prolong the survival of patients. This study is a clinical study to explore the efficacy and safety of maintenance therapy with sintilimab after 4-6 cycles of first-line chemotherapy combined with adoptive cellular immunotherapy in patients with advanced small cell lung cancer.

Publications & conference data

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

1. Signal pathways and precision therapy of small-cell lung cancer.
   Yuan M, Zhao Y, Arkenau HT, Lao T, et al · · 2022 · cited 72× · PMID 35705538 · DOI 10.1038/s41392-022-01013-y
2. Revising the Landscape of Cytokine-Induced Killer Cell Therapy in Lung Cancer: Focus on Immune Checkpoint Inhibitors.
   Vaseq R, Sharma A, Li Y, Schmidt-Wolf IGH. · · 2023 · cited 10× · PMID 36982701 · DOI 10.3390/ijms24065626
3. Toxicities of Immunotherapy for Small Cell Lung Cancer.
   Fu Y, Zheng Y, Wang PP, Ding ZY. · · 2021 · cited 9× · PMID 34136376 · DOI 10.3389/fonc.2021.603658
4. Sintilimab maintenance therapy post first-line cytokine-induced killer cells plus chemotherapy for extensive-stage small cell lung cancer.
   Ma B, Zhou Y, Shang Y, Zhang Y, et al · · 2022 · cited 5× · PMID 36158690 · DOI 10.3389/fonc.2022.852885
5. Current Landscape of Immunotherapy Trials Involving the Programmed Cell Death Protein 1/Programmed Death-Ligand 1 Axis in Intrathoracic Tumors.
   Kareff SA, Samtani S, Burotto M, Prasad V, et al · · 2021 · cited 3× · PMID 34590006 · DOI 10.1016/j.jtocrr.2021.100149
6. Old but gold: the role of drug combinations in improving response to immune check-point inhibitors in thoracic malignancies beyond NSCLC.
   Cantini L, Pecci F, Merloni F, Lanese A, et al · · 2021 · cited 2× · PMID 36046087 · DOI 10.37349/etat.2021.00030
7. On the way of the new strategies aimed to improve the efficacy of PD-1/PD-L1 immune checkpoint blocking mAbs in small cell lung cancer.
   Correale P, Giannicola R, Saladino RE, Nardone V, et al · · 2020 · cited 1× · PMID 33209592 · DOI 10.21037/tlcr-20-536