A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer

Conditions

• Metastatic
• Non Small Cell Lung Cancer
• Recurrent

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

This study will test the safety of the combination of ramucirumab and lorlatinib. The researchers will test one or two different doses of lorlatinib in combination with ramucirumab to find the drug combination dose that causes few or mild side effects in participants. Once the researchers find this dose, they can test it in future participants to see if it is effective in treating their metastatic ALK-rearranged NSCLC. The researchers are also looking to see whether there are specific genes or DNA sequences associated with a response to treatment with lorlatinib and ramucirumab.

Key Dates

Start date

Aug 17, 2023

Status verified

Apr 2026

Primary completion

Aug 17, 2028

Completion

Aug 17, 2028

Study Design

Enrollment

56 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Lorlatinib and ramucirumab
  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.

Primary Outcome Measure

Maximum tolerated dose (MTD) (Phase I) [ Time Frame: 1 year ]

Central Contacts

• Gregory Riely, MD, PhD
  646-608-3913
  [email protected]
• Alexander Drilon, MD
  646-608-3758

Locations (6)

Find similar trials in Middletown, NJ

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