Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06007937 | A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer | PHASE1 | RECRUITING | 56 | — | — | Aug 17, 2023 | Aug 17, 2028 | Apr 8, 2026 | 6 | United States |
Dose limiting toxicities using the NCI Common Terminology Criteria for Adverse Events Version 5 (NCI-CTCAE) will be used to grade toxicities during the trial.
by RECIST
| Arm | Type | Description |
|---|---|---|
| Lorlatinib and ramucirumab | EXPERIMENTAL | The phase 1 safety portion of the study will assess whether a dose of lorlatinib 100 mg orally daily and ramucirumab 10 mg/kg intravenous infusion once every three weeks is a tolerable and safe dose. Six patients will be enrolled at this dose level and assessed for dose limiting toxicities (DLTs) for one full cycle (21 days). Once the phase 1 portion of the study is complete, patients will be enrolled in the phase 2 portion of the study, cohort expansion at the MTD. Patients will be enrolled in two patient cohorts: cohort 1, treatment-naïve and cohort 2, patients who have progressed on prior second-generation ALK TKI. A cycle will be 21 days in length. Response to therapy will initially be assessed by interval imaging every 2 cycles. |
| Name | Type | Description |
|---|---|---|
| Lorlatinib | DRUG | Lorlatinib 100 mg orally daily |
| Ramucirumab | DRUG | Ramucirumab 10 mg/kg intravenous infusion once every three weeks is a tolerable and safe dose. |
Inclusion Criteria: * Written informed consent * Age \>18 years old * Metastatic or recurrent, biopsy-proven non-small cell lung cancer * ALK fusion identified by next generation sequencing (NGS) or IHC on material obtained from tumor or plasma * Measurable (RECIST 1.1) indicator lesion not previou...