Clinical trial · Interventional
Study of NXP900 With Lorlatinib in ALK+ Lung Cancer
A Phase 1b Clinical Study of NXP900 in Combination With Lorlatinib in Subjects With Advanced, ALK-positive, Non-Small Cell Lung Cancer
NCT07784959CI-TRIAL-00123767recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK+ Non-Small-Cell Lung Carcinoma | — | UNRESOLVED | — |
| ALK Positive | — | UNRESOLVED | — |
| ALK Positive Non-small Cell Lung Cancer | ALK-Positive Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lorlatinib | Drug | Lorlatinib | ALIAS |
| NXP900 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Exploration
- description
- Escalating doses of NXP900 given with lorlatinib
- interventionNames
- Drug: NXP900
- Drug: Lorlatinib
Primary outcomes (4)
- measure
- Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
- timeFrame
- Up to 30 days post treatment
- measure
- Objective response rate (ORR)
- timeFrame
- Up to approximately 12 months
- description
- Best response of complete response (CR) or partial response (PR) per RECIST 1.1
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.