NCT04670107

The Combination of Anlotinib and Immune Checkpoint Inhibitors for Advanced NSCLC Patients With Muti-line Therapy

Completed Phase 1, PHASE2 Last updated 17 December 2020

What this trial tests

Phase 1, PHASE2 trial testing Anlotinib in combination with Immune checkpoint inhibitors in NSCLC in 30 participants. Completed in 1 November 2020.

Timeline

1 June 2018

Primary endpoint
1 October 2020

1 November 2020

Quick facts

Lead sponsor	The Affiliated Hospital of Qingdao University
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 June 2018
Primary completion	1 October 2020
Estimated completion	1 November 2020
Sites	1 location across China

Drugs / interventions tested

• Anlotinib in combination with Immune checkpoint inhibitors — full drug profile →

Conditions studied

• NSCLC — all drugs for NSCLC →
• Angiogenesis — all drugs for Angiogenesis →
• Immunotherapy — all drugs for Immunotherapy →

Sponsor

The Affiliated Hospital of Qingdao University

Who can join

18 and older, any sex, with NSCLC or Angiogenesis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Immunotherapy has made a major progress in Lung cancer.However, challenges such as primary and acquired resistance, small fraction of benefit population and lack of predictive and prognostic biomarkers even exist. The overall objective response rate is lower than 20% in second line-treatment and the progression-free survival (PFS) is also similar to or poorer than that of conventional second-line chemotherapy. Anlotinib is a novel, orally administered, multitarget receptor tyrosine kinase inhibitor that inhibits VEGFR, PDGFR, FGFR, c-Kit, and other kinases. It functions by inhibiting tumor angiogenesis and proliferative signaling pathways. We would observe and analyze the effectiveness and safety of anlotinib combined with Immune checkpoint inhibitors for advanced NSCLC after muti-line therapy to explore the synergistic effect of anti-angiogenic agents and immunotherapy.

Publications & conference data

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

1. Tumor immunotherapies by immune checkpoint inhibitors (ICIs); the pros and cons.
   Naimi A, Mohammed RN, Raji A, Chupradit S, et al · · 2022 · cited 350× · PMID 35392976 · DOI 10.1186/s12964-022-00854-y
2. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
   Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
3. Current treatments for non-small cell lung cancer.
   Guo Q, Liu L, Chen Z, Fan Y, et al · · 2022 · cited 75× · PMID 36033435 · DOI 10.3389/fonc.2022.945102
4. Failure of Immunotherapy-The Molecular and Immunological Origin of Immunotherapy Resistance in Lung Cancer.
   Błach J, Wojas-Krawczyk K, Nicoś M, Krawczyk P. · · 2021 · cited 44× · PMID 34445735 · DOI 10.3390/ijms22169030
5. The benefit and risk of PD-1/PD-L1 inhibitors plus anti-angiogenic agents as second or later-line treatment for patients with advanced non-small-cell lung cancer: a systematic review and single-arm meta-analysis of prospective clinical trials.
   Chen S, Mo W, Jiang W, Zhou S, et al · · 2023 · cited 12× · PMID 37614237 · DOI 10.3389/fimmu.2023.1218258
6. Enhancing the Potential of Immunotherapy in Paediatric Sarcomas: Breaking the Immunosuppressive Barrier with Receptor Tyrosine Kinase Inhibitors.
   Fleuren EDG, Terry RL, Meyran D, Omer N, et al · · 2021 · cited 9× · PMID 34944614 · DOI 10.3390/biomedicines9121798
7. Efficacy and safety of camrelizumab-based comprehensive treatment for non-small cell lung cancer: a systematic review and meta-analysis.
   Maimaitiyiming N, Li Y, Cao Y, Li Y. · · 2024 · cited 1× · PMID 39376584 · DOI 10.1177/17588359241284904