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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | sunvozertinib (DZD9008) (EGFR inhibitor, HER2 inhibitor, BTK inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A study to assess the Safety, Tolerability, Pharmacokinetics and Anti tumor Efficacy of DZD9008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 mutation Estudio para evaluar la seguridad, la tolerabilidad, la farmacocinética y la eficacia antitumoral de DZD9008 en pacientes con cáncer de pulmón no microcítico (CPNM) avanzado con mutación de EGFR o HER2
Excerpt:
...If a patient declines to participate in any voluntary exploratory research and/or genetic component of the study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspect of the study.Part A of the study (Phase I):Dose escalationPatients must have documented histologically or cytologically confirmed locally advanced or metastatic NSCLC with EGFR or HER2 mutations, and have relapsed from, been refractory to or are intolerant to prior standard therapy without preferred alternative therapy.Dose expansionDose expansion cohort 1 and cohort 2: NSCLC patients with EGFR Exon20ins or HER2 Exon20ins, who have relapsed from, been refractory to or are intolerant to at least one line of prior systemic therapy.Dose expansion cohort 3 and cohort 4: NSCLC patients with EGFR Exon20ins, who have relapsed from, been refractory to or are intolerant to at least one line of prior systemic therapy.Dose expansion cohort 5: NSCLC patients with EGFR Exon20ins, who have not received prior systemic therapy (treatment naïve).Dose expansion cohort 6: NSCLC patients with EGFR Exon20ins, who have recevied at least one line of prior systemic therapy, and must have relapsed from, been refractory to or intolerant to Amivantamab treatment.Part B of the study (Phase II):Patients must have histologically or cytologically confirmed locally advanced or metastatic NSCLC with EGFR Exon20ins which is confirmed by central laboratory using an analytically validated next generation sequencing-based assay in archived tumor samples (if a patient has more than one FFPE blocks, the most recent tissue is preferred) or any fresh tumor biopsies (if archived tumor sample is not available) prior to the study entry. ...
Trial ID:
Source:
Title:
DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29)
Excerpt:
...To investigate the safety and tolerability of DZD9008 in combination with Bevacizumab in patients with locally advanced NSCLC harboring EGFR mutations. ...
Trial ID:
More C2 evidence
Source:
Title:
Assessing an Oral EGFR Inhibitor, DZD9008 in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
Excerpt:
...With documented histological or cytological confirmed locally advanced or metastatic NSCLC with EGFR or HER2 mutations....
Trial ID:
Source:
Title:
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer
Excerpt:
...Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation 4....
Trial ID:
Source:
Title:
Assessing the Effect of DZD9008 on the Pharmacokinetics of the Cocktail Probes Representative for CYP3A4, P-gp, BCRP and OATP1B1 in Patients With EGFR or HER2 Mutant Advanced Non-small Cell Lung Cancer (WU-KONG19)
Excerpt:
...- Patients must have documented histologically or cytologically confirmed locally advanced or metastatic NSCLC with EGFR or HER2 mutations and have progressed from, been refractory to or are intolerant to prior standard therapy without preferred alternative therapy....
Trial ID:
Source:
Title:
DZD9008 in Pretreated Lung Cancer Patients With EGFR Exon20 Insertion Mutation
Excerpt:
...Tumor tissue EGFR exon 20 insertion mutations confirmed by qualified local laboratories or sponsor-designated central laboratories....
Trial ID:
Source:
Title:
Assessing an Oral EGFR Inhibitor, DZD9008 in Patients With Advanced Non-small Cell Lung Cancer(NSCLC) With EGFR Mutations (WU-KONG15)
Excerpt:
...Histologically or cytologically confirmed locally advanced or metastatic NSCLC with documented EGFR mutations from a local laboratory 4....
Trial ID:
Less C2 evidence
Source:
Title:
Sunvozertinib, a Selective EGFR Inhibitor for Previously Treated Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Published date:
07/06/2022
Excerpt:
In addition, the preliminary antitumor activity of sunvozertinib was also observed in patients with EGFR sensitizing mutation, EGFR sensitizing/T790M double mutation, and HER2exon20ins (Supplementary Table S8).
DOI:
https://doi.org/10.1158/2159-8290.CD-21-1615
