Assessing an Oral EGFR Inhibitor, DZD9008 in Patients With Advanced Non-small Cell Lung Cancer(NSCLC) With EGFR Mutations (WU-KONG15)

ConditionNon Small Cell Lung Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorPeking Union Medical College Hospital

About this trial

This study is a single center cohort study to access the anti-tumor efficacy, safety and tolerability of DZD9008 in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations and EGFR uncommon mutations who have progressed following standard TKI therapy, and in treatment naive patients with NSCLC harboring EGFR Exon20 insertion mutation and EGFR sensitizing mutations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

To provide a signed and dated, written informed consent.

Aged ≥ 18 years old

Histologically or cytologically confirmed locally advanced or metastatic NSCLC with documented EGFR mutations from a local laboratory

ECOG performance status 0-1.

Disqualifiers

Known history of bleeding diathesis.

Prior malignancy within 2 years requires active treatment.

Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of first administration.

History of stroke or intracranial haemorrhage within 6 months before the first administration.

Trial design

Design model

Single group

Treatments tested in this trial

DZD9008
Drug
Daily dosing of DZD9008 200mg
DZD9008
Drug
Daily dosing of DZD9008 300mg

Treatment groups

180 Participants

are divided into 8 treatment groups

Treatment groups

See each treatment group below.

Group A: Cohort 1: EGFR sensitizing mutations, T790M negExperimental treatment 1 intervention

Group B: Cohort 2: EGFR sensitizing mutationsExperimental treatment 1 intervention

Group C: Cohort 3: EGFR uncommon mutationsExperimental treatment 1 intervention

Group D: Cohort 4: EGFR Exon20insExperimental treatment 1 intervention

Group E: Cohort 5: EGFR sensitizing mutationsExperimental treatment 1 intervention

Group F: Cohort 6: EGFR sensitizing mutations,T790M posExperimental treatment 1 intervention

Group G: Cohort 7: EGFR Exon20ins treatment naiveExperimental treatment 1 intervention

Group H: Cohort 8: treatment-naïve advanced or metastatic NSCLC harbouring EGFR PACC mutationsExperimental treatment 1 intervention