OncoMatch/Clinical Trials/NCT06031688
Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)
Is NCT06031688 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ramucirumab and Tepotinib for recurrent lung non-small cell carcinoma.
Treatment: Ramucirumab · Tepotinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: MET exon 14 skipping mutation
MET exon 14 skipping mutation determined by tissue-based or blood-based (circulating tumor DNA [ctDNA]) next generation sequencing (NGS) assay
Required: EGFR sensitizing mutation
Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations
Required: EGFR T790M mutation
Participants must not have other known actionable oncogenic alterations, such as (but not limited to) ... EGFR T790M mutation
Required: ALK fusion
Participants must not have other known actionable oncogenic alterations, such as (but not limited to) ... ALK gene fusion
Required: ROS1 rearrangement
Participants must not have other known actionable oncogenic alterations, such as (but not limited to) ... ROS1 gene rearrangement
Required: RET rearrangement
Participants must not have other known actionable oncogenic alterations, such as (but not limited to) ... RET gene rearrangement
Required: NTRK1 rearrangement
Participants must not have other known actionable oncogenic alterations, such as (but not limited to) ... NTRK rearrangement
Required: NTRK2 rearrangement
Participants must not have other known actionable oncogenic alterations, such as (but not limited to) ... NTRK rearrangement
Required: NTRK3 rearrangement
Participants must not have other known actionable oncogenic alterations, such as (but not limited to) ... NTRK rearrangement
Required: HER2 (ERBB2) mutation
Participants must not have other known actionable oncogenic alterations, such as (but not limited to) ... HER2 mutation
Required: KRAS activating mutation
Participants must not have other known actionable oncogenic alterations, such as (but not limited to) ... KRAS activating mutations
Required: BRAF V600E mutation
Participants must not have other known actionable oncogenic alterations, such as (but not limited to) ... BRAF V600E mutation
Disease stage
Required: Stage IV (AJCC v8)
documentation of stage IV or recurrent NSCLC
Performance status
ZUBROD 0–1
Prior therapy
Cannot have received: MET inhibitor (crizotinib, tivantinib, savolitinib, tepotinib, cabozantinib, foretinib)
Participants must not have received any prior MET inhibitor therapies (e.g., crizotinib, tivantinib, savolitinib, tepotinib, cabozantinib, and foretinib).
Cannot have received: angiogenesis inhibitor (bevacizumab, ramucirumab)
Participants must not have received treatment with prior angiogenesis inhibitor therapies (including but not limited to bevacizumab and ramucirumab)
Cannot have received: systemic chemotherapy
Exception: within 21 days prior to sub-study randomization
Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study randomization
Cannot have received: immunotherapy
Exception: within 21 days prior to sub-study randomization
Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study randomization
Cannot have received: investigational drug
Exception: within 21 days prior to sub-study randomization
Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study randomization
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 x 10^3/uL; Hemoglobin ≥ 9.0 g/dL; Platelets ≥ 100 x 10^3/uL
Kidney function
Serum creatinine ≤ institutional ULN or calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault); cystatin C test required
Liver function
Total bilirubin ≤ 1.5 x institutional ULN unless history of Gilbert's disease (≤ 5 x ULN if Gilbert's); AST and ALT ≤ 2.5 × ULN (≤ 5 x ULN if liver metastasis)
Cardiac function
Adequate cardiac function; if cardiac history or risk, NYHA class 2B or better
Absolute neutrophil count ≥ 1.5 x 10^3/uL ... Hemoglobin ≥ 9.0 g/dL ... Platelets ≥ 100 x 10^3/uL ... Total bilirubin ≤ 1.5 x institutional ULN unless history of Gilbert's disease ... AST and ALT ≤ 2.5 × institutional ULN ... Serum creatinine ≤ the institutional ULN or calculated creatinine clearance ≥ 30 mL/min ... cystatin C test ... adequate cardiac function ... NYHA class 2B or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis · Daphne, Alabama
- Thomas Hospital · Fairhope, Alabama
- Mobile Infirmary Medical Center · Mobile, Alabama
- Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland · Saraland, Alabama
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro · Jonesboro, Arkansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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