NCT03790228

Anlotinib Combined With Pemetrexed And Carboplatin as First-line Treatment in Advanced Nonsquamous NSCLC

Status unknown Phase 1 Last updated 15 April 2020

What this trial tests

Phase 1 trial testing Anlotinib Combined With Pemetrexed And Carboplatin in Non-squamous Cell Non-Small Cell Lung Cancer in 43 participants. Status unknown.

Timeline

22 March 2019

Primary endpoint
1 October 2020

31 August 2021

Quick facts

Lead sponsor	Henan Cancer Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	22 March 2019
Primary completion	1 October 2020
Estimated completion	31 August 2021
Sites	1 location across China

Drugs / interventions tested

• Anlotinib Combined With Pemetrexed And Carboplatin — full drug profile →

Conditions studied

• Non-squamous Cell Non-Small Cell Lung Cancer — all drugs for Non-squamous Cell Non-Small Cell Lung Cancer →

Sponsor

Henan Cancer Hospital

Who can join

Adults 18 to 75, any sex, with Non-squamous Cell Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In recent years, with the progress in the treatment field, Non-Small Cell Lung Cancer(NSCLC) has become the most successful cancer species in precision medicine. Patients with positive driving genes such as EGFR, ALK, ROS1, BRAF and so on have clearly targeted drugs, which bring survival benefits to patients.However, about 50% of patients still lack a clear driving gene target, which has become the focus of current research.In the field of wild-type NSCLC with negative driver genes, the classic first-line treatment regimen is the two-drug regimen containing platinum.The study by Kimura T in the first-line treatment of 54 wild-type advanced NSCLC patients with carboplatin and pemetrexed showed that the ORR, mPFS and mOS of patients with wild-type non-squamous NSCLC treated with carboplatin permetrexine were 35.8%, 5.4 months and 12.7 months respectively.

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development.In the phase Ⅲ study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 5.37 months and 9.46 months, the placebo group PFS and OS were 1.4 months and 6.37 months.

The efficacy and safety of Anlotinib combined with Pemetrexed and Carboplatin followed by maintenance therapy with Anlotinib plus Pemetrexed as the first-line treatment in patients with advanced nonsquamous NSCLC deserve further exploration.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and safety of anlotinib combined with carboplatin and pemetrexed as first-line induction therapy followed by anlotinib plus pemetrexed as maintenance therapy in <i>EGFR/ALK</i> wild-type advanced non-squamous non-small cell lung cancer in China: a multicenter, single-arm
   He Z, Yang X, Ma T, Yang Q, et al · · 2022 · cited 4× · PMID 36090635 · DOI 10.21037/tlcr-22-558