Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)

Conditions

• Recurrent Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Minutes - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood and urine sample collection
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Lymphoscintigraphy — PROCEDURE
  Undergo lymphoscintigraphy scan
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Ramucirumab — BIOLOGICAL
  Given IV
• Tepotinib — DRUG
  Given PO

Study Details

This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.

Key Dates

Start date

Aug 8, 2024

Status verified

May 2026

Primary completion

May 31, 2028

Completion

May 31, 2028

Study Design

Enrollment

56 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: (Ramucirumab and tepotinib)
  Patients receive ramucirumab IV over 30-60 minutes on day 1 of each cycle and tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients optionally undergo lymphoscintigraphy scan at screening prior to treatment, at the first occurrence of peripheral edema (defined as the development of grade ≥ 1 CTCAE Edema Limbs affecting either the arms, hands, or legs), and if peripheral edema increases in attribution. Patients also undergo blood collection, CT scan and/or MRI throughout the trial. Additionally, patients undergo urine collection during screening and on study.
• Active Comparator: Arm B: (Tepotinib)
  Patients receive tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients optionally undergo lymphoscintigraphy scan at screening prior to treatment, at the first occurrence of peripheral edema (defined as the development of grade ≥ 1 CTCAE Edema Limbs affecting either the arms, hands, or legs), and if peripheral edema increases in attribution. Patients also undergo blood collection, CT scan and/or MRI throughout the trial. Additionally, patients undergo urine collection during screening and on study.

Primary Outcome Measure

Response rate [ Time Frame: Up to 3 years from date of sub-study randomization ]

Locations (266)

Find similar trials in Daphne, AL

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