NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC

NCT05246514

Active Not RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: HER2-mutant Non-Small Cell Lung Cancer

Interventions: Trastuzumab deruxtecan

Countries: China

The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Pathologically documented metastatic non-squamous NSCLC.
* Has relapsed from or is refractory to at least one-line of anticancer treatment.
* Documented HER2 exon 19 or 20 mutation from central FFPE tumour tissue testing.
* WHO or ECOG performance status of 0 or 1.
* Presence of at least one measurable lesion assessed by the investigator based on RECIST 1.1.
* LVEF ≥ 50% within 28 days before enrolment.

Exclusion Criteria:

* Mixed small cell lung cancer, squamous histology NSCLC, and sarcomatoid histology variant NSCLC.
* Corrected QT interval (QTcF) prolongation to \> 470 ms (females) or \> 450 ms (males), based on average of the screening triplicate 12-lead ECG.
* History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Has unresolved toxicities from previous anticancer therapy, defined as toxicities (excluding alopecia) not yet resolved to Grade ≤1 or baseline. Participants with clinically stable chronic Grade 2 toxicity not reasonably expected to be exacerbated by study intervention may be included only after consultation with the AstraZeneca study physician or designee.
* Has been previously treated with HER2-targeted therapies, except for pan-HER class TKIs or has received prior treatment with an ADC which consists of an exatecan derivative that is a topoisomerase I inhibitor.
Locations (28)
  • Baoding, China
  • Beijing, China
  • Beijing, China
  • Changchun, China
  • Changsha, China
  • Changsha, China
  • Chengdu, China
  • Chongqing, China
  • Guangzhou, China
  • Guangzhou, China
  • Hangzhou, China
  • Hangzhou, China
  • Harbin, China
  • Hefei, China
  • Hefei, China
  • Linyi, China
  • Nanjing, China
  • Shandong, China
  • Shanghai, China
  • Shanghai, China
  • Shenyang, China
  • Shenzhen, China
  • Wuhan, China
  • Wuhan, China
  • Xi'an, China
  • Xiamen, China
  • Yangzhou, China
  • Zhengzhou, China