Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Lung Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

All Drugs and Chemicals

Amino Acids

Mitogens

Dacomitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

All subjects will receive the open-label Dacomitinib as tablets for oral self-administration on a continuous daily basis at a dose of 30 mg for one cycle. For subjects eligible for dose titration after Cycle 1, and after shared patient and investigator decision, these subjects will receive Dacomitinib 45 mg orally on a continuous daily basis.

Oral Dacomitinib

Daniel SW Tan

Boon Cher Goh

Eligible subjects will be allocated to one of four cohorts based on tumour type and presence of specific biomarker.

Subjects will receive open-label Dacomitinib as tablets for oral administration on a continuous daily basis at a dose of 30 mg for one cycle. After one cycle, a toxicity assessment will be conducted. Subjects with \>=G2 toxicity attributable to dacomitinib, will continue dacomitinib at 30 mg orally once daily.

In subjects with \<=G1 toxicity, investigator and subjects will make a shared decision for dose escalation of dacomitinib to 45 mg orally once daily or continuation of dacomitinib at 30 mg orally once daily. Subjects will then continue on therapy until disease progression, new systemic anticancer therapy instituted, intolerable toxicities, withdrawal of consent, death, or investigator decision dictated by protocol compliance, whichever occurs first.

Eligible subjects will be allocated to one of four cohorts based on tumour type and presence of specific biomarker. All subjects in cohorts 1 to 3 will have tumours that demonstrate low EGFR-AS1 lncRNA expression as determined through a companion diagnostic biomarker suite (consisting of three components - EGFR Q787Q AA genotype, low AS1 lncRNA levels and increased EGFR isoform D/A ratio).

* Cohort 1 will consist of squamous NSCLC patients with the presence of at least 1 out of 3 in the biomarker suite.
* Cohort 2 will consist of HNSCC patients with the presence of at least 1 out of 3 in the biomarker suite.
* Cohort 3 will consist of any other solid tumour with the presence of at least 1 out of 3 in the biomarker suite.
* Cohort 4 will have tumours that demonstrate the presence of a novel emerging biomarker including but not limited to NRG1 fusions and specific MET SNPs.

Phase-2 Dacomitinib Study on Patients With EGFR-Driven Advanced Solid Tumours With Low EGFR-AS1 IncRNA Expr or Other Novel Emerging Biomarkers

A Phase II Multi-Centre Study Evaluating the Efficacy of Dacomitinib for Patients With Epidermal Growth Factor Receptor (EGFR)-Driven Advanced Solid Tumours With Low EGFR-AS1 IncRNA Expression or Other Novel Emerging Biomarkers

The proportion of subjects with a BOR of either CR or PR, where BOR is the best response recorded from the start of treatment until disease progression.

The time from start of treatment to the date of disease progression or death due to any cause, whichever occurs first.

The time from the initial response to therapy to the date of subsequent disease progression or date of death (if cause of death is due to PD), whichever earlier.

Spots Global Cancer Trial Database for novel emerging biomarker