About this trial
This is a multi-center, open label, Phase 1b study of NXP900 in combination with lorlatinib in subjects with advanced, ALK-positive non-small cell lung cancer (NSCLC)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years old or older
Unresectable, metastatic or locally advanced ALK-positive NSCLC.
Must have received lorlatinib as first or second line TKI
One prior line of systemic chemotherapy is permitted
Disqualifiers
Known single or compound ALK domain mutations that cause resistance to lorlatinib, or known actionable oncogenic driver alterations other than ALK with approved targeted therapies available, such as, MET or EGFR mutations or HER2 overexpression
Any contraindications to treatment with lorlatinib according to the lorlatinib United States Prescribing Information (USPI)
Trial design
Sequential
Treatments tested in this trial
NXP900
DrugNXP900 is an orally administered inhibitor of SRC family kinases (SFK)
Lorlatinib
DrugLorlatinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC)
Treatment groups
Trial outcomes
Primary outcomes
Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
Objective response rate (ORR)
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
Duration of Response (DoR)
Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
Disease Control Rate (DCR)
The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).
Sponsors and contacts
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