Study of NXP900 With Lorlatinib in ALK+ Lung Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNuvectis Pharma, Inc.

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • NXP900

    Drug

    NXP900 is an orally administered inhibitor of SRC family kinases (SFK)

  • Lorlatinib

    Drug

    Lorlatinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC)

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Dose ExplorationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of patients with treatment related adverse events and/or clinical laboratory abnormalities

Time frame
Up to 30 days post treatment
2

Objective response rate (ORR)

Best response of complete response (CR) or partial response (PR) per RECIST 1.1

Time frame
Up to approximately 12 months
3

Duration of Response (DoR)

Confirmed CR or PR from the first documented response to the date of documented disease progression or death.

Time frame
Up to approximately 12 months
4

Disease Control Rate (DCR)

The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).

Time frame
Up to approximately 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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