Phase 1/2 of TAK-788 in Non-Small Cell Lung Cancer
Research type
Research Study
Full title
A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer
IRAS ID
257847
Contact name
Sanjaykumar Popat
Contact email
Sponsor organisation
Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
Eudract number
2016-001271-68
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 8 months, 30 days
Research summary
In 15-40% of patients with NSCLC, the EGFR mutations play an important role in tumour growth. One class of most effective agents used to treat NSCLC with EGFR mutations is tyrosine kinase inhibitor (TKI). TKIs currently approved have produced high response rates of about 60-70% in NSCLC patients with common EGFR mutations, however approximately 9% of EGFR mutant NSCLC patients have EGFR exon 20 in-frame insertion mutations for which there are currently no targeted therapy is approved. TAK-788 has been created to address this and potentially inhibits most activating EGFR mutations including EGFR exon 20 insertion. TAK-788 is being tested in this study in three parts (dose escalation, dose expansion and extension) however the UK will only take part in the last part, which will test how efficacious TAK-788 at 160mg QD dose is in treatment of previously treated locally advanced or metastatic NSCLC patients whose tumours harbour EGFR exon 20 insertion mutations.
Approximately 91 participants will be enrolled into part 3 at about 100 sites in the UK and other countries. Each participant will be treated in the study for up to 3 years until disease progression or intolerance to the treatment. Participants will experience 2 weeks of screening procedures before treatment. After screening, apart from a visit at day 15 during the first cycle, participants will visit the study site for various tests and to receive more medication on day 1 of each cycle (every 28 days). During these visits participants will undergo various assessments and procedures such as blood sampling, urine sampling, CSF sampling, ECGs, a CT or MRI, tumour sampling and answering of quality of life questionnaires. Participants will be followed up for safety 30 days after last dose and for survival status every 12 weeks after discontinued from the treatment until participants contact cease.REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0700
Date of REC Opinion
24 May 2019
REC opinion
Further Information Favourable Opinion