ALK PositivePhase 1NCT07784959
Study of NXP900 With Lorlatinib in ALK+ Lung Cancer
A Phase 1 study testing NXP900 and Lorlatinib in people with ALK Positive and ALK Positive Non-small Cell Lung Cancer, run by Nuvectis Pharma, Inc. at 1 site in United States.
Trial summary
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) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ALK Positive, ALK Positive Non-small Cell Lung Cancer, NSCLC
- What is being tested?
- NXP900 and Lorlatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2026to Feb 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- Must have tolerated the dose level of lorlatinib actively being explored in the study or a higher dose
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shay Shemesh contact
United States1 site, 1 recruiting
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
About this study
Official title: A Phase 1b Clinical Study of NXP900 in Combination With Lorlatinib in Subjects With Advanced, ALK-positive, Non-Small Cell Lung Cancer
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)
- Conditions
- ALK Positive, ALK Positive Non-small Cell Lung Cancer, NSCLC, ALK+ Non-Small-Cell Lung Carcinoma
- Being tested
- NXP900, Lorlatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NXP900Drug
NXP900 is an orally administered inhibitor of SRC family kinases (SFK)
LorlatinibDrug
Lorlatinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC)
| Study group | Role | What they receive |
|---|---|---|
| Dose Exploration | Experimental | Escalating doses of NXP900 given with lorlatinib Receives: Drug: NXP900; Drug: Lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
Measured: Up to 30 days post treatment
Objective response rate (ORR)
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
Measured: Up to approximately 12 months
Duration of Response (DoR)
Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
Measured: Up to approximately 12 months
Disease Control Rate (DCR)
The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start17 Aug 2026
- Primary completionAug 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuvectis Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Lovly, MD, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784959
- Sponsor's protocol ID
- NXP900-102
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No