This study is about a medicine called TAK-788, also known as mobocertinib, given to adults
with non-small cell lung cancer.
The main aims of this study are to check if there are any side effects from TAK-788, to learn
how TAK-788 is processed by the body, and to determine the best dose of TAK-788 to treat this
Participants will take TAK-788 capsules with chemotherapy. Participants will continue to take
TAK-788 unless they or their doctor decide they should stop this treatment.
Participants will take TAK-788 capsules with or without chemotherapy under antidiarrhea
prevention to determine the safety of TAK-788 treatment.
This phase 1/2 study will evaluate the safety, pharmacokinetics, and anti-tumor activity of
oral EGFR/HER2 Inhibitor TAK-788 in participants with NSCLC and anti-tumor activity of
TAK-788 in participants with solid tumors other than NSCLC with EGFR or HER2 mutations. The
trial will be conducted in three parts: a dose escalation (Part 1), including Part 1A (dose
escalation combination component of TAK-788 in combination with Pemetrexed/Carboplatin) and
Part 1B (TAK-788 monotherapy and TAK-788 in combination with pemetrexed/carboplatin with
primary antidiarrhea prevention with loperamide.) and expansion phase (Part 2), followed by
an extension phase (Part 3).
The objectives of the dose escalation phase (Part 1),dose escalation combination phase (Part
1A, only for selected sites in the United States) and Antidiarrhea Prophylaxis Cohorts ( part
1B, only for selected sites in the United States) are to determine the safety profile of
orally administered TAK-788 and TAK-788 in combination with Pemetrexed/Carboplatin, including
the MTD, DLTs, RP2D,pharmacokinetic profile and with loperamide as primary antidiarrhea
prevention incidence and severity of TAK-788-associated diarrhea and anti-tumor activity of
TAK-788 (Part 1B) . The primary goal of the expansion component of the trial is to evaluate
the anti-tumor activity of TAK-788 in seven histologically and molecularly defined cohorts at
the RP2D (determined based on dose escalation phase of the trial).
The seven expansion cohorts will be:
NSCLC participants with EGFR exon 20 activating insertions, who have either not received
or not shown an objective response to an EGFR TKI, and who have no active, measurable
NSCLC participants with HER2 exon 20 activating insertions or point mutations and no
active, measurable CNS metastases;
NSCLC participants with EGFR exon 20 activating insertions or HER2 exon 20 activating
insertions or point mutations and active, measurable CNS metastases;
NSCLC participants with other targets against which TAK-788 is active (examples include
EGFR exon 19 deletions or exon 21 substitutions [with or without T790M mutations] and
other uncommon EGFR activating mutations), without active CNS metastases;
NSCLC participants with EGFR exon 20 activating insertions, who have previously shown an
objective response to an EGFR TKI and subsequently progressed, without active CNS
NSCLC participants with EGFR exon 20 activating insertions, who have not received prior
systemic anticancer treatment for locally advanced or metastatic disease, without active
CNS metastases; and
Participants with solid tumors other than NSCLC with EGFR/HER2 mutations against which
TAK-788 is active, without active CNS metastases.
The extension phase will evaluate efficacy of TAK-788 in participants with locally advanced
or metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations and who have been
previously treated. The study will enroll approximately 395 participants.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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